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A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training

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ClinicalTrials.gov Identifier: NCT02274675
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Collaborators:
National Stroke Association of Malaysia (NASAM)
Collaborative Research in Engineering, Science and Technology Center (CREST)
Ministry of Higher Education (Lab2Market)
Information provided by (Responsible Party):
Dr.Yeong Che Fai, Universiti Teknologi Malaysia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Device: Robot-assisted therapy for wrist and forearm
Other: Standard rehabilitation therapy
Enrollment 7
Recruitment Details The recruitment started on 1st June 2014 for 4 months duration in a stroke rehabilitation centre.
Pre-assignment Details  
Arm/Group Title Robot Group
Hide Arm/Group Description

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

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Robot Group
Hide Arm/Group Description

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 Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  85.7%
>=65 years
1
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
59.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Motor Impairment of Wrist and Forearm   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores
Number Analyzed 7 participants
20.29  (4.86)
[1]
Measure Description: 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.
Motor Function Assessment of Hand Movement   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores
Number Analyzed 7 participants
0.29  (0.76)
[1]
Measure Description: 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. The score range = 2 and the best/worst score = 2/0 scores.
Spasticity Level of Wrist   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores
Number Analyzed 7 participants
1  (0.82)
[1]
Measure Description: 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. The score range = 4 and the best/worst score = 0/4 scores.
Forearm's Active Range of Movement   [1] 
Mean (Standard Deviation)
Unit of measure:  Angular degree
Number Analyzed 7 participants
76.29  (52.37)
[1]
Measure Description: 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.
Forearm's Passive Range of Motion   [1] 
Mean (Standard Deviation)
Unit of measure:  Angular degree
Number Analyzed 7 participants
168.57  (12.19)
[1]
Measure Description: 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.
Wrist's Passive Range of Motion   [1] 
Mean (Standard Deviation)
Unit of measure:  Angular degree
Number Analyzed 7 participants
121.57  (14.55)
[1]
Measure Description: 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.
Wrist's Active Range of Motion   [1] 
Mean (Standard Deviation)
Unit of measure:  Angular degree
Number Analyzed 7 participants
64.14  (45.86)
[1]
Measure Description: 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.
1.Primary Outcome
Title Motor Impairment of Wrist and Forearm
Hide Description

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.

Time Frame Motor impairment of wrist and forearm at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Scores
23.57  (6.58)
2.Secondary Outcome
Title Motor Function Assessment of Hand Movement
Hide Description

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.

Time Frame Motor function of hand function at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Scores
1.14  (1.07)
3.Secondary Outcome
Title Spasticity Level of Wrist
Hide Description

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.

Time Frame Spasticity level of wrist at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Scores
0.57  (0.79)
4.Secondary Outcome
Title Forearm's Active Range of Movement
Hide Description

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.

Time Frame Active range of motion of forearm at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Angular degree
134.71  (31.34)
5.Secondary Outcome
Title Forearm's Passive Range of Motion
Hide Description

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.

Time Frame Passive range of motion of forearm at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Angular degree
180  (0)
6.Secondary Outcome
Title Wrist's Passive Range of Motion
Hide Description

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.

Time Frame Passive range of motion of wrist at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Angular degree
132  (26.39)
7.Secondary Outcome
Title Wrist's Active Range of Motion
Hide Description

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.

Time Frame Active range of motion of wrist at week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Stroke subjects in rehabilitation centre.
Arm/Group Title Robot Group
Hide Arm/Group Description:

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 Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: Angular degree
100.14  (26.23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Robot Group
Hide Arm/Group Description

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

All-Cause Mortality
Robot Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Robot Group
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Robot Group
Affected / at Risk (%)
Total   0/7 (0.00%) 
The limitations of this study include the relatively small number of subjects in each group, the variation in severity level across subjects and also the lack of comparison groups to differentiate the improvement benefit from robot therapy.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Project Leader
Organization: Universiti Teknologi Malaysia
Responsible Party: Dr.Yeong Che Fai, Universiti Teknologi Malaysia
ClinicalTrials.gov Identifier: NCT02274675     History of Changes
Other Study ID Numbers: UTM-CR2-001
First Submitted: October 21, 2014
First Posted: October 24, 2014
Results First Submitted: May 2, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015