search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Robot-assisted therapy for wrist and forearm
Standard rehabilitation therapy
Sponsored by
Universiti Teknologi Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Robot-assisted therapy, Rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sub-acute and chronic stroke patients
  • Able to rest comfortable in training set-up
  • Mini-Mental Status Examination (MMSE) Score (>21)
  • Motor Assessment Scale (Balance sitting >3)
  • Modified Ashworth Scale (Wrist < 2)

Exclusion Criteria:

  • Contractures in affected upper extremity which inhibit movements being tested

Sites / Locations

  • National Stroke Association of Malaysia (NASAM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robot group

Arm Description

Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy

Outcomes

Primary Outcome Measures

Motor Impairment of Wrist and Forearm
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.

Secondary Outcome Measures

Motor Function Assessment of Hand Movement
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.
Spasticity Level of Wrist
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.
Forearm's Active Range of Movement
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.
Forearm's Passive Range of Motion
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.
Wrist's Passive Range of Motion
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.
Wrist's Active Range of Motion
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.

Full Information

First Posted
October 21, 2014
Last Updated
July 3, 2015
Sponsor
Universiti Teknologi Malaysia
Collaborators
National Stroke Association of Malaysia (NASAM), Collaborative Research in Engineering, Science and Technology Center (CREST), Ministry of Higher Education (Lab2Market)
search

1. Study Identification

Unique Protocol Identification Number
NCT02274675
Brief Title
A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Official Title
A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Malaysia
Collaborators
National Stroke Association of Malaysia (NASAM), Collaborative Research in Engineering, Science and Technology Center (CREST), Ministry of Higher Education (Lab2Market)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.
Detailed Description
The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Robot-assisted therapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot group
Arm Type
Experimental
Arm Description
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Intervention Type
Device
Intervention Name(s)
Robot-assisted therapy for wrist and forearm
Other Intervention Name(s)
CR2-Haptic Rehabilitation Robot
Intervention Description
Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation therapy
Intervention Description
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
Primary Outcome Measure Information:
Title
Motor Impairment of Wrist and Forearm
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
Secondary Outcome Measure Information:
Title
Motor Function Assessment of Hand Movement
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
Title
Spasticity Level of Wrist
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
Title
Forearm's Active Range of Movement
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
Title
Forearm's Passive Range of Motion
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
Title
Wrist's Passive Range of Motion
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
Title
Wrist's Active Range of Motion
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sub-acute and chronic stroke patients Able to rest comfortable in training set-up Mini-Mental Status Examination (MMSE) Score (>21) Motor Assessment Scale (Balance sitting >3) Modified Ashworth Scale (Wrist < 2) Exclusion Criteria: Contractures in affected upper extremity which inhibit movements being tested
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeong C Fai, PhD
Organizational Affiliation
Universiti Teknologi Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Stroke Association of Malaysia (NASAM)
City
Petaling Jaya
State/Province
Kuala Lumpur
ZIP/Postal Code
46050
Country
Malaysia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs