Trial Outcomes & Findings for Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI (NCT NCT01765153)
NCT ID: NCT01765153
Last Updated: 2017-05-02
Results Overview
This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
COMPLETED
NA
21 participants
Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)
2017-05-02
Participant Flow
Participant milestones
| Measure |
Endurance First
Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Precision Training 5x/wk for 2 months. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.
|
|---|---|---|
|
Training Phase 1
STARTED
|
10
|
11
|
|
Training Phase 1
COMPLETED
|
9
|
10
|
|
Training Phase 1
NOT COMPLETED
|
1
|
1
|
|
Rest Phase 1
STARTED
|
9
|
10
|
|
Rest Phase 1
COMPLETED
|
9
|
9
|
|
Rest Phase 1
NOT COMPLETED
|
0
|
1
|
|
Training Phase 2
STARTED
|
10
|
9
|
|
Training Phase 2
COMPLETED
|
10
|
8
|
|
Training Phase 2
NOT COMPLETED
|
0
|
1
|
|
Rest Phase 2
STARTED
|
10
|
8
|
|
Rest Phase 2
COMPLETED
|
8
|
7
|
|
Rest Phase 2
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Endurance First
Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Precision Training 5x/wk for 2 months. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.
|
|---|---|---|
|
Training Phase 1
Format of intervention differed
|
1
|
0
|
|
Training Phase 1
Poor participation in intervention
|
0
|
1
|
|
Rest Phase 1
Withdrawal by Subject
|
0
|
1
|
|
Training Phase 2
Withdrawal by Subject
|
0
|
1
|
|
Rest Phase 2
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI
Baseline characteristics by cohort
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=11 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
45.9 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study
|
-128.77 units on a scale
Standard Deviation 180.73
|
-64.07 units on a scale
Standard Deviation 77.24
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IThis is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I
|
-129.09 units on a scale
Standard Deviation 165.06
|
-69.51 units on a scale
Standard Deviation 106.51
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IThis is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=9 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I
|
-1.04 units on a scale
Standard Deviation 49.67
|
10.34 units on a scale
Standard Deviation 74.23
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIThis is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Outcome measures
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II
|
-15.28 units on a scale
Standard Deviation 31.74
|
-13.35 units on a scale
Standard Deviation 31.58
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIThis is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II
|
1.61 units on a scale
Standard Deviation 34.13
|
16.10 units on a scale
Standard Deviation 63.86
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IParticipants walk for as far as possible in 6 min along a 25m hallway.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I
|
32.75 metres
Standard Deviation 40.07
|
17.43 metres
Standard Deviation 26.67
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IParticipants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=9 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I
|
6.78 metres
Standard Deviation 32.69
|
32.23 metres
Standard Deviation 46.41
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIParticipants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.
Outcome measures
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II
|
3.9 metres
Standard Deviation 11.11
|
25.78 metres
Standard Deviation 26.60
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training to 2 months of Rest Period IIParticipants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II
|
-14.63 metres
Standard Deviation 29.94
|
17.00 metres
Standard Deviation 23.60
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IParticipants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I
|
0.07 m/s
Standard Deviation 0.06
|
0.06 m/s
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IParticipants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=9 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I
|
0.04 m/s
Standard Deviation 0.12
|
0.09 m/s
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIParticipants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II
|
0.02 m/s
Standard Deviation 0.04
|
0.06 m/s
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIParticipants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II
|
-0.02 m/s
Standard Deviation 0.12
|
-0.09 m/s
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IPopulation: Measure was added to study protocol midway through study. 5 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I
|
0.07 m/s
Standard Deviation 0.09
|
0.21 m/s
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IPopulation: Measure was added to study protocol midway through study. 4 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=5 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I
|
0.04 m/s
Standard Deviation 0.18
|
0.14 m/s
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIPopulation: Measure was added to study protocol midway through study. 3 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II
|
0.06 m/s
Standard Deviation 0.09
|
0.09 m/s
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIPopulation: Measure was added to study protocol midway through study. 2 out of 16 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.
Outcome measures
| Measure |
Endurance First
n=7 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=7 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II
|
-0.09 m/s
Standard Deviation 0.11
|
0.12 m/s
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IParticipants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I
|
0.32 units on a scale
Standard Deviation 0.65
|
1.30 units on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IParticipants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=9 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I
|
-0.22 units on a scale
Standard Deviation 0.67
|
-0.22 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIParticipants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II
|
0.50 units on a scale
Standard Deviation 1.58
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIParticipants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IPopulation: Measure was added to study protocol midway through study. 3 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I
|
0.73 units on a scale
Standard Deviation 1.08
|
1.63 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IPopulation: Measure was added to study protocol midway through study. 2 out of 17 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I
|
-0.25 units on a scale
Standard Deviation 0.53
|
-0.19 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIPopulation: Measure was added to study protocol midway through study. 1 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.
Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II
|
0.22 units on a scale
Standard Deviation 1.33
|
0.44 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIParticipants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task. Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II
|
0.00 units on a scale
Standard Deviation 0.00
|
-0.50 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IA survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage. Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I
|
4.15 percentage of confidence in balance
Standard Deviation 9.54
|
3.15 percentage of confidence in balance
Standard Deviation 8.79
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IA survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage. Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=9 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I
|
0.38 percentage of confidence in balance
Standard Deviation 8.23
|
1.70 percentage of confidence in balance
Standard Deviation 3.90
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIA survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage. Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Outcome measures
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II
|
3.78 Percentage of confidence in balance
Standard Deviation 5.37
|
6.48 Percentage of confidence in balance
Standard Deviation 10.52
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIA survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage. Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II
|
-0.08 percentage of confidence in balance
Standard Deviation 5.20
|
-0.63 percentage of confidence in balance
Standard Deviation 5.44
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IA 20 question survey to measure current level of depressive symptoms. The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60. Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I
|
-3.85 units on a scale
Standard Deviation 5.40
|
-2.42 units on a scale
Standard Deviation 6.95
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IA 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60. Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=9 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I
|
0.61 units on a scale
Standard Deviation 1.98
|
-0.64 units on a scale
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIA 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60. Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Outcome measures
| Measure |
Endurance First
n=10 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II
|
-2.75 units on a scale
Standard Deviation 2.95
|
-0.53 units on a scale
Standard Deviation 3.70
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIA 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60. Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II
|
3.25 units on a scale
Standard Deviation 5.92
|
-0.25 units on a scale
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IThe strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=10 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I
|
1.29 units on a scale
Standard Deviation 2.51
|
2.50 units on a scale
Standard Deviation 5.60
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IPopulation: This measure was accidentally omitted for 1 participant at the end of this phase. Data analysed for all participants who performed this measure.
The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I
|
-2.45 units on a scale
Standard Deviation 4.19
|
-1.06 units on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIPopulation: This measure was accidentally omitted for 1 participant at beginning of this phase. Data analysed for all participants who performed this measure.
The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II
|
1.22 units on a scale
Standard Deviation 2.90
|
0.56 units on a scale
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIThe strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.
Outcome measures
| Measure |
Endurance First
n=8 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=8 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II
|
-3.00 units on a scale
Standard Deviation 3.36
|
0.07 units on a scale
Standard Deviation 4.76
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IPopulation: Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.
Reflexes are elicited in standing by electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG) in µV.
Outcome measures
| Measure |
Endurance First
n=6 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=7 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I
|
-6.84 µV
Standard Deviation 6.00
|
2.36 µV
Standard Deviation 17.35
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IPopulation: Data was analysed for the 13 participants who provided CMR data in Training phase 1 in order to dtermine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis
Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.
Outcome measures
| Measure |
Endurance First
n=5 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I
|
0.18 µV
Standard Deviation 5.60
|
4.35 µV
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIPopulation: Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.
Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.
Outcome measures
| Measure |
Endurance First
n=7 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II
|
3.01 µV
Standard Deviation 7.09
|
-5.97 µV
Standard Deviation 11.14
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIPopulation: Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine whether training effect was maintained. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.
Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.
Outcome measures
| Measure |
Endurance First
n=4 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=5 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II
|
2.13 µV
Standard Deviation 5.56
|
1.82 µV
Standard Deviation 14.42
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase ISingle-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=7 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I
|
122.9 Percentage of baseline mep
Standard Error 7.8
|
113.9 Percentage of baseline mep
Standard Error 9.0
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period ISingle-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=7 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I
|
115.1 percentage of baseline mep
Standard Error 14.2
|
121.7 percentage of baseline mep
Standard Error 7.1
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IISingle-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.
Outcome measures
| Measure |
Endurance First
n=9 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=7 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II
|
124.3 percentage of baseline mep
Standard Error 12.4
|
111.0 percentage of baseline mep
Standard Error 9.7
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIMaximum evoked potentials were measured and compared to baseline measures for major muscle groups.
Outcome measures
| Measure |
Endurance First
n=7 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II
|
141.0 percentage of baseline MEP
Standard Error 17.1
|
111.6 percentage of baseline MEP
Standard Error 10.4
|
SECONDARY outcome
Timeframe: Change from Baseline I to 2 months of Training Phase IPopulation: Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Outcome measures
| Measure |
Endurance First
n=6 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=7 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I
|
0.28 µV
Standard Deviation 3.76
|
0.14 µV
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period IPopulation: Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Outcome measures
| Measure |
Endurance First
n=5 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I
|
1.04 µV
Standard Deviation 3.54
|
0.38 µV
Standard Deviation 6.43
|
SECONDARY outcome
Timeframe: Change from Baseline II to 2 months of Training Phase IIPopulation: Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Outcome measures
| Measure |
Endurance First
n=7 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=6 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II
|
0.73 µV
Standard Deviation 2.76
|
-0.26 µV
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period IIPopulation: Data was analysed for the 13 participants who provided CMR data in Training phase 1. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.
Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.
Outcome measures
| Measure |
Endurance First
n=4 Participants
Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
|
Precision First
n=5 Participants
Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
|
|---|---|---|
|
Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II
|
0.53 µV
Standard Deviation 3.11
|
0.63 µV
Standard Deviation 6.17
|
Adverse Events
Endurance First
Precision First
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place