Effects of Robot-Assisted Combined Therapy in Upper Limb Rehabilitation in Stroke Patients
NCT ID: NCT02319785
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2014-08-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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RAT-NMES
The combined treatment of robot-assisted therapy and neuromuscular electrical stimulation.
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.
RAT-MT
The combined treatment of robot-assisted therapy and mirror therapy.
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.
Mirror therapy
Patients practice motion in a mirror box, and look into mirror while practicing.
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.
Unilateral RAT
Unilateral robot-assisted therapy provided by InMotion Isokinetic Testing and Evaluation System.
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.
Bilateral RAT
Bilateral robot-assisted therapy provided by Bi-Manu-Track.
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).
Conventional rehabilitation
Conventional rehabilitation provided by therapist.
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.
Interventions
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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.
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.
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.
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.
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).
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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National Taiwan University
OTHER
Chang Gung University
OTHER
Chang Gung Memorial Hospital
OTHER
Cheng-Hsin General Hospital
OTHER
Lo-Sheng Sanatorium
OTHER_GOV
Cathay General Hospital
OTHER
Responsible Party
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Principal Investigators
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Keh-Chung Lin, Dr.
Role: STUDY_DIRECTOR
National Taiwan University
Chia-Yi Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Cathay General Hospital
Ming-wei Lee
Role: PRINCIPAL_INVESTIGATOR
Cathay General Hospital
Locations
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Cathay General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chia-Yi Lee, MD
Role: primary
Other Identifiers
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CathayGH
Identifier Type: -
Identifier Source: org_study_id