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Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients

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ClinicalTrials.gov Identifier: NCT02319785
Recruitment Status : Unknown
Verified December 2014 by Cathay General Hospital.
Recruitment status was:  Recruiting
First Posted : December 18, 2014
Last Update Posted : December 18, 2014
Sponsor:
Collaborators:
National Taiwan University
Chang Gung University
Chang Gung Memorial Hospital
Cheng-Hsin General Hospital
Lo-Sheng Sanatorium
Information provided by (Responsible Party):
Cathay General Hospital

Tracking Information
First Submitted Date  ICMJE October 7, 2014
First Posted Date  ICMJE December 18, 2014
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • change of kinematic analyses [ Time Frame: within three days before and immediately after the intervention ]
    A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used.The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), maximum shoulder and elbow cross-correlation and variables of gait pattern were collected.
  • change of Fugl-Meyer Assessment [ Time Frame: within three days before and immediately after the intervention ]
    The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
  • change of 10-Meter Walk Test (10MWT) [ Time Frame: within three days before and immediately after the intervention ]
    The 10MWT assess mobility function by measuring the time and the numbers of strides required to walk 10 meters under two conditions: (1) with the self-pace of each participant (self-pace); (2) with the speed that the participants walked as soon as possible. The velocity and stride length of the participant are calculated. Research has validated the 10MWT in measuring mobility in stroke.
  • change of Wolf Motor Function Test [ Time Frame: within three days before and immediately after the intervention ]
    The WMFT requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal."
  • change of Functional Independence Measure [ Time Frame: within three days before and immediately after the intervention ]
    The FIM consists of 18 items grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 (maximum score 126) based on the required level of assistance to perform the tasks (e.g., 1-complete assistance and 7-complete independence). A higher score on any subscale indicates a less disability.
  • change of The Action Research Arm Test [ Time Frame: within three days before and immediately after the intervention ]
    The ARAT assesses the ability to handle objects with 19 items divided into 4 subscales of grasp, grip, pinch, and gross movement by 4-level ordinal scale. Higher the score, better the performance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 15, 2014)
  • change of Medical Research Council scale [ Time Frame: within three days before and immediately after the intervention ]
    The MRC assessment measures the muscle strength of the proximal (shoulder flexors, shoulder abductors, elbow flexors, and elbow extensors) and distal (wrist and finger flexors and extensors) parts of the affected arm. The MRC score of each muscle ranges from 0 (no muscle contraction) to 5 (normal strength).
  • change of Functional Ambulation Categories [ Time Frame: within three days before and immediately after the intervention ]
    Functional Ambulation Categories is rated from 1 to 6 based on the required level of assistance to perform the basic motor skills necessary for functional ambulation.
  • change of Modified Ashworth Scale [ Time Frame: within three days before and immediately after the intervention ]
    The MAS grades spasticity from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion and extension). We measured the muscle tone of the shoulder, elbow, forearm, wrist, and finger and calculated the averaged MAS scores of the proximal (shoulder and elbow) and distal (forearm, wrist, and finger) portions.
  • change of Motor Activity Log [ Time Frame: within three days before and immediately after the intervention ]
    The MAL is a semistructured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected UL in 30 important daily activities using a 6-point ordinal scale.
  • change of ABILHAND Questionnaire [ Time Frame: within three days before and immediately after the intervention ]
    The ABILHAND questionnaire is a self-report assessment of UE function that consists of 23 bilateral activities in daily life. Patients were asked to estimate their difficulty in performing each activity using a 3-point ordinal scale.
  • change of Stroke Impact Scale Version 3.0 [ Time Frame: within three days before and immediately after the intervention ]
    The SIS is a 59-item self-report scale designed to assess 8 functional domains including strength, memory, emotion, communication, activities of daily living (ADLs)/instrumental ADLs, mobility, hand function, and participation using a 5-point ordinal scale, with established reliability and validity.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
Official Title  ICMJE Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
Brief Summary The main purpose of this study is to examine the treatment effects and the combined-therapy of the robot-assisted therapy (RAT) by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in the investigators trial to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.
Detailed Description

Stroke remains a leading cause of permanent disability in Taiwan and many other countries. The high incidence of stroke and the decreased mortality from stroke which imply the urgent needs for effective rehabilitation. Various contemporary rehabilitation interventions focused on restoring upper limb motor function have been advocated for stroke rehabilitation. Robot-assisted therapy (RAT), one current prominent activity-based approach, has emerged that incorporates therapeutic elements for success in stroke motor rehabilitation: combined with neuromuscular electrical stimulation and mirror therapy into its design. However, scientific evidence for the effects of the RAT and its combined-therapy on functional outcomes (e.g., motor and daily functions) in stroke patients remains limited. Furthermore, there is a need to identify the proper protocol and intervention type. This research project will use randomized controlled trial design to address these issues.

The main purpose of this study is to examine the treatment effects and the combined-therapy of the RAT by using two groups of combined-therapy with different sensory feedback and one group of unilateral RAT in our trail to compare the relative treatment effects to mirror therapy group, bilateral RAT, and conventional rehabilitation (CR) considering motor ability, basic daily functions, mobility, quality of life, and kinematic variables.

The inclusion criteria of subjects are first-ever unilateral stroke with more than 3 months onset ; (2) an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment; (3) no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers); (4) be able to follow study instructions and perform study tasks; (5) without upper limb fracture within 3 months; (6) lack of participation in any experimental rehabilitation or drug studies during the study period; (7) welling to provide written informed consent ; and (8) able to realize and respond to oral instructions. Patients with neural or psychological medical history, recurrent stroke or attack by epilepsy during the intervention will be excluded. Expected sample size is 120.

Subjects will be randomly assigned to one of the six groups: (1) robot-assisted therapy combined with neuromuscular electrical stimulation (RAT-NMES) ; (2) robot-assisted therapy combined with mirror therapy (RAT-MT) ; (3) mirror therapy group; (4) unilateral robot-assisted therapy group ; (5) bilateral robot-assisted therapy and (6) conventional rehabilitation (CR). All subjects in the study will receive treatment from registered occupational therapist 1.5 hours each day, five days a week for four weeks. Pretest and posttest will be hold before and after the intervention to check if the subjects had any improvement. The outcome measures are kinematic analysis of the upper and lower limb movement variables, the Fugl-Meyer Assessment (FMA), Medical Research Council scale (MRC), MYOTON-3, accelerometers, Functional Ambulation Category (FAC), Ten-meter walk test, Functional Independence Measure (FIM), Stroke Impact Scale (SIS), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), ABILHAND, Motor Activity Log (MAL), and Modified Ashworth Scale (MAS). All the data will be calculated by SPSS 13.0. Subject's age, sex, time after stroke in each group will be compared by descriptive statistics. The change of outcome measures after intervention in each group will be calculated by ANOVA to see if combined therapy had better effectiveness than the other groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebrovascular Accident
Intervention  ICMJE
  • Behavioral: RAT-NMES
    This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive neuromuscular electrical stimulation (NMES) concurrently with RAT.
    Other Names:
    • RAT combined neuromuscular electrical stimulation
    • RAT-neuromuscular electrical stimulation
  • Behavioral: RAT-MT
    This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive mirror therapy instead of functional activities training after RAT.
    Other Names:
    • RAT combined MT
    • RAT-mirror therapy
  • Behavioral: Mirror therapy
    This protocol includes mirror therapy and functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
    Other Name: MT
  • Behavioral: Unilateral RAT

    This protocol includes warm-up, unilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks.

    The unilateral RAT session uses the robot-assisted arm trainer, InMotion Isokinetic Testing and Evaluation System.

    Other Name: URAT
  • Behavioral: Bilateral RAT

    This protocol includes warm-up, bilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks.

    The unilateral RAT session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).

    Other Name: BRAT
  • Behavioral: Conventional rehabilitation
    Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RAT and MT groups.
    Other Names:
    • CR
    • Control treatment
    • CT
Study Arms  ICMJE
  • Experimental: RAT-NMES
    The combined treatment of robot-assisted therapy and neuromuscular electrical stimulation.
    Intervention: Behavioral: RAT-NMES
  • Experimental: RAT-MT
    The combined treatment of robot-assisted therapy and mirror therapy.
    Intervention: Behavioral: RAT-MT
  • Active Comparator: Mirror therapy
    Patients practice motion in a mirror box, and look into mirror while practicing.
    Intervention: Behavioral: Mirror therapy
  • Experimental: Unilateral RAT
    Unilateral robot-assisted therapy provided by InMotion Isokinetic Testing and Evaluation System.
    Intervention: Behavioral: Unilateral RAT
  • Active Comparator: Bilateral RAT
    Bilateral robot-assisted therapy provided by Bi-Manu-Track.
    Intervention: Behavioral: Bilateral RAT
  • Active Comparator: Conventional rehabilitation
    Conventional rehabilitation provided by therapist.
    Intervention: Behavioral: Conventional rehabilitation
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 15, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. first-ever unilateral stroke with more than 3 months onset ;
  2. an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment;
  3. no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers);
  4. be able to follow study instructions and perform study tasks;and
  5. willing to provide written informed consent.

Exclusion Criteria:

  1. with neural or psychological medical problem that may influence the study;
  2. with severe joint pain;
  3. with upper limb fracture within 3 months;
  4. participation in any experimental rehabilitation or drug studies during the study period; and
  5. refusing to provide written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02319785
Other Study ID Numbers  ICMJE CathayGH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cathay General Hospital
Study Sponsor  ICMJE Cathay General Hospital
Collaborators  ICMJE
  • National Taiwan University
  • Chang Gung University
  • Chang Gung Memorial Hospital
  • Cheng-Hsin General Hospital
  • Lo-Sheng Sanatorium
Investigators  ICMJE
Study Director: Keh-Chung Lin, Dr. National Taiwan University
Principal Investigator: Chia-Yi Lee, MD Cathay General Hospital
Principal Investigator: Ming-wei Lee Cathay General Hospital
PRS Account Cathay General Hospital
Verification Date December 2014

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