Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
1 other identifier
interventional
45
1 country
2
Brief Summary
The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.
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 Sep 2014
Typical duration for not_applicable stroke
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 15, 2016
September 1, 2016
2 years
September 29, 2014
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change scores of Fugl-Meyer assessment(FMA)
baseline, 2 weeks, 4 weeks
Secondary Outcomes (23)
Change scores of Box and block test (BBT)
baseline, 2 weeks, 4 weeks
Change scores of Action research arm test (ARAT)
baseline, 2 weeks, 4 weeks
Change scores of Medical Research Council scale (MRC)
baseline, 2 weeks, 4 weeks
Change scores of Modified Ashworth scale (MAS)
baseline, 2 weeks, 4 weeks
Change scores of Myoton
baseline, 4 weeks
- +18 more secondary outcomes
Study Arms (3)
proximal robot-assisted therapy
EXPERIMENTALtreatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
distal robot-assisted therapy
EXPERIMENTALthe InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.
individualized intensive therapy
ACTIVE COMPARATORindividualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.
Interventions
Eligibility Criteria
You may qualify if:
- unilateral stroke that verified by CT scan
- Time since stroke more than 6 months
- moderate and mild upper limb motor impairment identified from the UE subtest of FMA range from 10 to 50
- Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands
You may not qualify if:
- serious visual or visual perception problems
- orthopedic or other neurological problems occurred in recent 6 months
- attend any other study in recent 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chang Gung Memorial Hospital
Kwei-Shan, Tao-Yuan, 333, Taiwan
Lo-Sheng Sanatorium and Hospital
Kwei-shan, Toayuan County, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Yi Wu, ScD
Chang Gung Memorial Hospital
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
September 29, 2014
First Posted
October 1, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 15, 2016
Record last verified: 2016-09