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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

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Behavioral: RAT-NMES Behavioral: RAT-MT Behavioral: Mirror therapy Behavioral: Unilateral RAT Behavioral: Bilateral RAT Behavioral: Conventional rehabilitation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
Study Start Date : August 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: RAT-NMES
The combined treatment of robot-assisted therapy and neuromuscular electrical stimulation.
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

Experimental: RAT-MT
The combined treatment of robot-assisted therapy and mirror therapy.
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

Active Comparator: Mirror therapy
Patients practice motion in a mirror box, and look into mirror while practicing.
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

Experimental: Unilateral RAT
Unilateral robot-assisted therapy provided by InMotion Isokinetic Testing and Evaluation System.
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

Active Comparator: Bilateral RAT
Bilateral robot-assisted therapy provided by Bi-Manu-Track.
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

Active Comparator: Conventional rehabilitation
Conventional rehabilitation provided by therapist.
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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."

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319785


Contacts
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Contact: Keh-Chung Lin, Dr. 886-2-33668180 kehchunglin@ntu.edu.tw
Contact: Chung-Shan Hung 886920603731 f00429003@ntu.edu.tw

Locations
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Taiwan
Cathay General Hospital Recruiting
Taipei, Taiwan
Contact: Chia-Yi Lee, MD    886-2-27082121      
Principal Investigator: Chia-Yi Lee, MD         
Sponsors and Collaborators
Cathay General Hospital
National Taiwan University
Chang Gung University
Chang Gung Memorial Hospital
Cheng-Hsin General Hospital
Lo-Sheng Sanatorium
Investigators
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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

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Responsible Party: Cathay General Hospital
ClinicalTrials.gov Identifier: NCT02319785     History of Changes
Other Study ID Numbers: CathayGH
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases