Trial Outcomes & Findings for Error Enhancement of the Velocity Component (NCT NCT02017093)
NCT ID: NCT02017093
Last Updated: 2016-01-13
Results Overview
While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.
COMPLETED
NA
7 participants
The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).
2016-01-13
Participant Flow
Participant milestones
| Measure |
Error Enhancement
Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.
|
Control Group: Traditional Therapy
Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Error Enhancement of the Velocity Component
Baseline characteristics by cohort
| Measure |
Study
n=4 Participants
Patients admitted to rehabilitation center after a stroke.
|
Control
n=3 Participants
Patients admitted to rehabilitation center after a stroke.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
57.33 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
59.14 years
STANDARD_DEVIATION 9.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Fugl-Meyer assessment score
|
53.2 units on a scale
STANDARD_DEVIATION 3.26 • n=5 Participants
|
54.3 units on a scale
STANDARD_DEVIATION 5.43 • n=7 Participants
|
53.7 units on a scale
STANDARD_DEVIATION 4.36 • n=5 Participants
|
PRIMARY outcome
Timeframe: The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.
Outcome measures
| Measure |
Error Enhancement
n=4 Participants
Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.
|
Control Group: Traditional Therapy
n=3 Participants
Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.
|
|---|---|---|
|
Improvement in Average Movement Trajectory Error From T1 to T2
|
2.31 cm
Standard Deviation 1.52
|
2.4 cm
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.
Outcome measures
| Measure |
Error Enhancement
n=4 Participants
Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.
|
Control Group: Traditional Therapy
n=3 Participants
Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.
Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement
Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included.
|
|---|---|---|
|
Fugl-Meyer Assessment Score
Fugl-Meyer score at T1
|
53.2 units on a scale
Standard Deviation 3.26
|
54.33 units on a scale
Standard Deviation 5.43
|
|
Fugl-Meyer Assessment Score
Fugl-Meyer score at T2
|
56.75 units on a scale
Standard Deviation 2.38
|
55.33 units on a scale
Standard Deviation 4.49
|
Adverse Events
Error Enhancement
Control Group: Traditional Therapy
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