Trial Outcomes & Findings for Discrete Versus Rhythmic Gait Training (NCT NCT02650440)
NCT ID: NCT02650440
Last Updated: 2017-09-18
Results Overview
The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2017-09-18
Participant Flow
Participant milestones
| Measure |
Novel Protocol
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
Baseline characteristics by cohort
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=10 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=10 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
5 Participants
n=8 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
14 Participants
n=18 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
0 Participants
n=8 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
0 Participants
n=18 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=10 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
3 Participants
n=8 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
4 Participants
n=18 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 14.4 • n=10 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
59.3 years
STANDARD_DEVIATION 13.8 • n=8 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
50.6 years
STANDARD_DEVIATION 14.3 • n=18 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
4 Participants
n=8 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
10 Participants
n=18 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
4 Participants
n=8 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
8 Participants
n=18 Participants • Two individuals from Standard Protocol did not receive allocated intervention due to clinical complications.
|
|
Region of Enrollment
Brazil
|
10 participants
n=10 Participants
|
8 participants
n=10 Participants
|
18 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksThe Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline.
Outcome measures
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=8 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Functional Ambulation Scale (FAC)
|
1 units on a scale
Interval 1.0 to 2.0
|
0 units on a scale
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksChange in distance of the gait applied test after intervention as compared to baseline
Outcome measures
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=8 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Six-minute Walking Test (6MWT)
|
25.4 meters
Standard Error 10.4
|
7.6 meters
Standard Error 14.1
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksThis test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return. This study compared the change in the time of the gait applied test after intervention as compared to baseline.
Outcome measures
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=8 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Time Up and Go (TUG)
|
-42.1 seconds
Standard Error 16.4
|
-11.3 seconds
Standard Error 22.9
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksChange in the time of the gait applied test after intervention as compared to baseline
Outcome measures
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=8 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Ten-meters Walking Test (10MWT)
|
-52.8 seconds
Standard Error 27.9
|
-20.3 seconds
Standard Error 30.5
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksThe Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment. This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline
Outcome measures
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=8 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Lower Limbs Fugl-Meyer
|
2.3 units on a scale
Standard Error 0.8
|
-1.1 units on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksBerg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance. The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points. A score below 45 is considered a fall risk. This study comparede the change in the balance control applied scale after intervention as compared to baseline.
Outcome measures
| Measure |
Novel Protocol
n=10 Participants
Progressive decrease of speed and guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.0 km/h.
Novel Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
|
Standard Protocol
n=8 Participants
Progressive increase of speed and decrease of guidance force on robotic gait training. Initial speed is 1.4 km/h and final speed is 1.9 km/h.
Standard Protocol: All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
|
|---|---|---|
|
Berg Scale
|
11.1 units on a scale
Standard Error 1.6
|
6.0 units on a scale
Standard Error 1.9
|
Adverse Events
Novel Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thais A. Rodrigues, MS, PT.
Coordination of Improvement of Higher Level Personnel - CAPES
Phone: 55 (61) 2022-6002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place