Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation
1 other identifier
interventional
72
1 country
3
Brief Summary
The aim of the project is to compare the effects of unilateral hybrid therapy \[unilateral robot-assisted therapy (RT)\] + unilateral arm training (UAT)\] and bilateral hybrid therapy \[bilateral RT + bilateral arm training (BAT)\] on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2015
Longer than P75 for not_applicable stroke
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 7, 2016
June 1, 2016
3.9 years
May 19, 2015
July 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change scores of Fugl-Meyer assessment(FMA)
baseline, 3 weeks, 6 weeks, 18 weeks
Secondary Outcomes (21)
Wolf Motor Function Test (WMFT)
baseline, 6 weeks
Change scores of Box and block test (BBT)
baseline, 3 weeks, 6 weeks, 18 weeks
Change scores of Action research arm test (ARAT)
baseline, 3 weeks, 6 weeks
Change scores of Medical Research Council scale (MRC)
baseline, 3 weeks, 6 weeks
Change scores of Modified Ashworth scale (MAS)
baseline, 3 weeks, 6 weeks
- +16 more secondary outcomes
Study Arms (3)
Unilateral Hybrid Intervention Group
EXPERIMENTALParticipants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.
Bilateral Hybrid Intervention Group
EXPERIMENTALParticipants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.
Robot-Assisted Training Group
EXPERIMENTALParticipants will receive 6 weeks of RT training using the BMT in each session.
Interventions
For the unilateral RT training, participants will practice with their affected arms following a unilateral training protocol of BMT for 45 minutes (Yang, et al., 2012). For the UAT training, participants will receive training of the affected UL in functional tasks with behavioral shaping for 45 minutes (Lin, Wu, et al., 2009).
For the bilateral RT training, patients will focus on training involving both arms using the BMT robot for 45 minutes. During the 45 minutes BAT training, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs.
The RT intervention will be matched in duration and intensity with the hybrid interventions. Participants in the RT group will practice on the BMT with bilateral protocols for 90 minutes. The tasks will be tailored according to the level
Eligibility Criteria
You may qualify if:
- ≥3 months onset from a first-ever unilateral stroke;
- minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits);
- an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment;
- no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers);
- able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22);
- without upper extremity fracture within 3 months;
- no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent.
You may not qualify if:
- acute inflammatory disease;
- major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Lo-Sheng Sanatorium and Hospital
Kwei-shan, Toayuan County, 333, Taiwan
Chang Gung Memorial Hospital
Kwei-Shan, Tao-Yuan, 333, Taiwan
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
Related Publications (1)
Hung CS, Lin KC, Chang WY, Huang WC, Chang YJ, Chen CL, Grace Yao K, Lee YY. Unilateral vs Bilateral Hybrid Approaches for Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Dec;100(12):2225-2232. doi: 10.1016/j.apmr.2019.06.021. Epub 2019 Aug 14.
PMID: 31421096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Yi Wu, ScD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2015
First Posted
May 21, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
July 7, 2016
Record last verified: 2016-06