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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274675
• Other study ID #: UTM-CR2-001
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2014
• Last updated: July 3, 2015
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Universiti Teknologi Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robot-assisted therapy for wrist and forearm
Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.

Other:
• Standard rehabilitation therapy
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities

Locations

Country	Name	City	State
Malaysia	National Stroke Association of Malaysia (NASAM)	Petaling Jaya	Kuala Lumpur

Sponsors (4)

Lead Sponsor	Collaborator
Universiti Teknologi Malaysia	Collaborative Research in Engineering, Science and Technology Center (CREST), Ministry of Higher Education (Lab2Market), National Stroke Association of Malaysia (NASAM)

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Motor impairment of wrist and forearm at week 6	No
Secondary	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.	Motor function of hand function at week 6	No
Secondary	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.	Spasticity level of wrist at week 6	No
Secondary	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.	Active range of motion of forearm at week 6	No
Secondary	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.	Passive range of motion of forearm at week 6	No
Secondary	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.	Passive range of motion of wrist at week 6	No
Secondary	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.	Active range of motion of wrist at week 6	No