Robot- Versus Mirror-Assisted Rehabilitation in Stroke Patients
1 other identifier
interventional
100
1 country
2
Brief Summary
The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Typical duration for not_applicable
2 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
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
November 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedNovember 9, 2012
November 1, 2012
2.4 years
August 28, 2012
November 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Fugl-Meyer Assessment (FMA)
2011/8 to 2013/1 (up to 2 years)
Study Arms (5)
Robotic assisted therapy
EXPERIMENTALThis protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
Mirror Therapy
EXPERIMENTALThis protocol includes 1 hour mirror therapy and 0.5 hour 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.
Conventional Rehabilitation
ACTIVE COMPARATORParticipants 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 RR and MT groups.
Robotic rehabilitation with FES
EXPERIMENTALThis combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
Robotic Rehabilitation with PI
PLACEBO COMPARATORThe RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.
Interventions
This protocol includes 1 hour mirror therapy and 0.5 hour 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.
This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.
This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
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 RR and MT groups.
Eligibility Criteria
You may qualify if:
- Willing to provide the written informed consent
- More than 6 months onset of unilateral stroke
- An initial 25-56 or 18-50 scores on the upper limb subtest of the Fugl-Meyer assessment (FMA)
- Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
- Without upper limb fracture within 3 months
You may not qualify if:
- Recurrent of stroke or seizure episode during the intervention
- Occurrence of serious or continuous pain on affected upper-extremity
- History of other neurological disease or severe orthopaedic condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan University Hosipital
Taipei, Taiwan, 100, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keh-chung Lin, ScD
School of Occupational Therapy, College of Medicine, National Taiwan University
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
August 28, 2012
First Posted
November 9, 2012
Study Start
August 1, 2011
Primary Completion
January 1, 2014
Study Completion
July 1, 2014
Last Updated
November 9, 2012
Record last verified: 2012-11