The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients
The Effect of Upper Limb Rehabilitation on the Application of Proximal Upper Rehabilitation Robot and Distal Upper Rehabilitation Robot With Stroke Patients
1 other identifier
interventional
68
1 country
1
Brief Summary
Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with 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 Oct 2019
Typical duration for not_applicable stroke
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
First Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 16, 2021
September 1, 2021
3.3 years
August 12, 2019
September 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Wolf motor function test
an activity indicator, has 15 items for testing functional ability
change from baseline at 4 weeks
Fugl-Meyer Assessment
indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment
change from baseline at 4 weeks
Secondary Outcomes (11)
Fugl-Meyer Assessment
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor activity log
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Action reach arm test
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor status score
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Box and block test
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
- +6 more secondary outcomes
Study Arms (2)
distal upper rehabilitation robot
EXPERIMENTALexperimental group that applied the distal upper rehabilitation robot
proximal upper rehabilitation robot
OTHERcontrol group that applied the proximal upper rehabilitation robot
Interventions
Intervention with distal upper rehabilitation robot
Intervention with proximal upper rehabilitation robot
Eligibility Criteria
You may qualify if:
- Hemiplegic patients secondary to first cerebrovascular accidents
- Onset ≥ 3 months
- ≤ Fugl-Meyer Assessment score
- 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, 142884, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joon-Ho Shin, MS
National Rehabilitation Center
Central Study Contacts
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
August 12, 2019
First Posted
August 13, 2019
Study Start
October 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share