Trial Outcomes & Findings for A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training (NCT NCT02274675)
NCT ID: NCT02274675
Last Updated: 2015-07-31
Results Overview
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject. Procedure: The procedure is done according to the standard guideline of this assessment scale.
COMPLETED
PHASE1
7 participants
Motor impairment of wrist and forearm at week 6
2015-07-31
Participant Flow
The recruitment started on 1st June 2014 for 4 months duration in a stroke rehabilitation centre.
Participant milestones
| Measure |
Robot Group
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Baseline characteristics by cohort
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Motor Impairment of Wrist and Forearm
|
20.29 Scores
STANDARD_DEVIATION 4.86 • n=5 Participants
|
|
Motor Function Assessment of Hand Movement
|
0.29 Scores
STANDARD_DEVIATION 0.76 • n=5 Participants
|
|
Spasticity Level of Wrist
|
1 Scores
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Forearm's Active Range of Movement
|
76.29 Angular degree
STANDARD_DEVIATION 52.37 • n=5 Participants
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|
Forearm's Passive Range of Motion
|
168.57 Angular degree
STANDARD_DEVIATION 12.19 • n=5 Participants
|
|
Wrist's Passive Range of Motion
|
121.57 Angular degree
STANDARD_DEVIATION 14.55 • n=5 Participants
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|
Wrist's Active Range of Motion
|
64.14 Angular degree
STANDARD_DEVIATION 45.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: Motor impairment of wrist and forearm at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject. Procedure: The procedure is done according to the standard guideline of this assessment scale.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Motor Impairment of Wrist and Forearm
|
23.57 Scores
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: Motor function of hand function at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement. Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2. Procedure: The procedure is done according to the standard guideline of this assessment scale.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Motor Function Assessment of Hand Movement
|
1.14 Scores
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Spasticity level of wrist at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale. Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed. Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Spasticity Level of Wrist
|
0.57 Scores
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Active range of motion of forearm at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: Forearm's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort. Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The normalized AROM for normal forearm pronation-supination is about 157 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree will be 0. Procedure: The forearm AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the subject will move their forearm to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Forearm's Active Range of Movement
|
134.71 Angular degree
Standard Deviation 31.34
|
SECONDARY outcome
Timeframe: Passive range of motion of forearm at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: Forearm's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually. Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition.The normalized forearm pronation-supination is about 169 angular degree, a person who is able to achieve or over this range is considered normal or in good condition in this study. The minimum angular degree is 0. Procedure: The forearm PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the forearm will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and stored as report in its software.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Forearm's Passive Range of Motion
|
180 Angular degree
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Passive range of motion of wrist at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: Wrist's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in flexion-extension directed by a person manually. Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized PROM for normal wrist flexion-extension is about 164 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0. Procedure: The wrist PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the wrist will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and store as report in its software.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Wrist's Passive Range of Motion
|
132 Angular degree
Standard Deviation 26.39
|
SECONDARY outcome
Timeframe: Active range of motion of wrist at week 6Population: Stroke subjects in rehabilitation centre.
Introduction: Wrist's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in by moving with their own effort. Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized AROM for normal wrist flexion-extension is about 144 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0. Procedure: The wrist's AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the subject will move their wrist to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software.
Outcome measures
| Measure |
Robot Group
n=7 Participants
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
|
|---|---|
|
Wrist's Active Range of Motion
|
100.14 Angular degree
Standard Deviation 26.23
|
Adverse Events
Robot Group
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