Comparisons of Two Types of Rehabilitation Robot for Upper Extremities
1 other identifier
interventional
40
1 country
1
Brief Summary
Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Apr 2015
1 active site
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
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedApril 12, 2017
April 1, 2017
1.9 years
October 23, 2016
April 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change of Fugl-Meyer Assessment
Fugl-Meyer Assessment change from baseline at 4 weeks
Wolf motor function test
Fugl-Meyer Assessment change from baseline at 4 weeks
Secondary Outcomes (16)
Wolf motor function test
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Motor status score
baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
medical research council scale of upper extremity
baseline
Modified Ashworth scale of upeer extremity
baseline
Pain of upper extremity
from baseline to 4 weeks after baseline
- +11 more secondary outcomes
Study Arms (2)
3D exoskeleton type robot
EXPERIMENTAL3 dimension exoskeleton type upper extremity robot
2D end-effector type robot
EXPERIMENTAL2 dimension end-effector type upper extremity robot
Interventions
3 dimension exoskeleton type upper extremity robot
2 dimension end-effector type upper extremity robot
Eligibility Criteria
You may qualify if:
- Hemiplegic patients secondary to first cerebrovascular accidents
- Onset ≥ 3 months
- ≤ Fugl-Meyer Assessment score ≤ 30
- Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
- Cognitively intact enough to understand and follow the instructions from the investigator
You may not qualify if:
- History of surgery of affected upper limb
- Fracture of affected upper limb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Rehabilitation Center
Seoul, Seoul, 142884, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joon-Ho Shin, MS
National Rehabilitation Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Team manager
Study Record Dates
First Submitted
October 23, 2016
First Posted
April 7, 2017
Study Start
April 1, 2015
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
April 12, 2017
Record last verified: 2017-04