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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

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 24, 2014
Results First Submitted Date  ICMJE May 2, 2015
Results First Posted Date  ICMJE July 31, 2015
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
Motor Impairment of Wrist and Forearm [ Time Frame: Motor impairment of wrist and forearm at week 6 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Motor Impairment of Wrist and Forearm [ Time Frame: Change from Baseline in motor impairment of wrist and forearm at week 6 and 12 ]
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm (Total of 26 points)
Change History Complete list of historical versions of study NCT02274675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2015)
  • Motor Function Assessment of Hand Movement [ Time Frame: Motor function of hand function at week 6 ]
    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 [ Time Frame: Spasticity level of wrist at week 6 ]
    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 [ Time Frame: Active range of motion of forearm at week 6 ]
    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 [ Time Frame: Passive range of motion of forearm at week 6 ]
    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 [ Time Frame: Passive range of motion of wrist at week 6 ]
    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 [ Time Frame: Active range of motion of wrist at week 6 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
  • Motor Function Assessment of Hand Movement [ Time Frame: Change from Baseline in motor function of hand function related to wrist and forearm at week 6 and 12 ]
    Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale (Total of 2 points)
  • Wrist and forearm active range of movement (AROM) [ Time Frame: Change from Baseline in AROM of wrist and forearm at weeks 6 and 12 ]
    Active range improvement for wrist and forearm which is measured by robot in term of angle
  • Wrist and forearm passive range of movement (PROM) [ Time Frame: Change from Baseline in PROM of wrist and forearm at weeks 6 and 12 ]
    Passive range improvement for wrist and forearm which is measured by robot in term of angle with the help of the therapist
  • Spasticity level of wrist and forearm [ Time Frame: Change from Baseline in spasticity level of wrist and forearm at week 6 and 12 ]
    Spasticity of wrist and forearm are measured using Modifed Ashworth Scale (Total of 4 points)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Official Title  ICMJE A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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 Name: CR2-Haptic Rehabilitation Robot
  • Other: Standard rehabilitation therapy
    Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
Study Arms  ICMJE Experimental: Robot group
Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy
Interventions:
  • Device: Robot-assisted therapy for wrist and forearm
  • Other: Standard rehabilitation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2014)
7
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2014)
6
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02274675
Other Study ID Numbers  ICMJE UTM-CR2-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.Yeong Che Fai, Universiti Teknologi Malaysia
Study Sponsor  ICMJE Universiti Teknologi Malaysia
Collaborators  ICMJE
  • National Stroke Association of Malaysia (NASAM)
  • Collaborative Research in Engineering, Science and Technology Center (CREST)
  • Ministry of Higher Education (Lab2Market)
Investigators  ICMJE
Principal Investigator: Yeong C Fai, PhD Universiti Teknologi Malaysia
PRS Account Universiti Teknologi Malaysia
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP