Trial Outcomes & Findings for Rehabilitating Corticospinal Control of Walking (NCT NCT02132650)
NCT ID: NCT02132650
Last Updated: 2022-05-05
Results Overview
self selected (preferred) steady state walking speed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
assessed pre-intervention (0 months) and post-intervention (3 months)
Results posted on
2022-05-05
Participant Flow
Participant milestones
| Measure |
Accurate Walking Training
Rehabilitation of walking using accurate (ACC) walking tasks
ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
|
Steady State Walking Training
Rehabilitation of walking using typical steady state (SS) walking
SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
18
|
|
Overall Study
Post-Intervention Assessment
|
19
|
17
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rehabilitating Corticospinal Control of Walking
Baseline characteristics by cohort
| Measure |
Accurate Walking Training
n=20 Participants
Rehabilitation of walking using accurate (ACC) walking tasks
ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
|
Steady State Walking Training
n=18 Participants
Rehabilitation of walking using typical steady state (SS) walking
SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Time since stroke
|
15.4 months
STANDARD_DEVIATION 10.0 • n=5 Participants
|
20.9 months
STANDARD_DEVIATION 10.5 • n=7 Participants
|
18.0 months
STANDARD_DEVIATION 10.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: assessed pre-intervention (0 months) and post-intervention (3 months)self selected (preferred) steady state walking speed
Outcome measures
| Measure |
Accurate Walking Training
n=19 Participants
Rehabilitation of walking using accurate (ACC) walking tasks
ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
|
Steady State Walking Training
n=17 Participants
Rehabilitation of walking using typical steady state (SS) walking
SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
|
|---|---|---|
|
Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months)
|
0.13 meters per second
Standard Deviation 0.11
|
0.14 meters per second
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: assessed pre-intervention (0 months) and follow-up (6 months)self selected (preferred) steady state walking speed
Outcome measures
| Measure |
Accurate Walking Training
n=19 Participants
Rehabilitation of walking using accurate (ACC) walking tasks
ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
|
Steady State Walking Training
n=17 Participants
Rehabilitation of walking using typical steady state (SS) walking
SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
|
|---|---|---|
|
Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months)
|
0.10 meters per second
Standard Deviation 0.12
|
0.07 meters per second
Standard Deviation 0.11
|
Adverse Events
Accurate Walking Training
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Steady State Walking Training
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Accurate Walking Training
n=20 participants at risk
Rehabilitation of walking using accurate (ACC) walking tasks
ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
|
Steady State Walking Training
n=18 participants at risk
Rehabilitation of walking using typical steady state (SS) walking
SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
|
|---|---|---|
|
Nervous system disorders
pain
|
5.0%
1/20 • Number of events 1 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
0.00%
0/18 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
|
General disorders
unstable medical condition
|
0.00%
0/20 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
Other adverse events
| Measure |
Accurate Walking Training
n=20 participants at risk
Rehabilitation of walking using accurate (ACC) walking tasks
ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
|
Steady State Walking Training
n=18 participants at risk
Rehabilitation of walking using typical steady state (SS) walking
SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
bone fracture occurring offsite
|
10.0%
2/20 • Number of events 2 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
0.00%
0/18 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
|
General disorders
falling
|
10.0%
2/20 • Number of events 2 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
27.8%
5/18 • Number of events 5 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
|
Nervous system disorders
seizure
|
0.00%
0/20 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
5.6%
1/18 • Number of events 1 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
|
General disorders
car accident
|
5.0%
1/20 • Number of events 1 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
0.00%
0/18 • Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place