Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
Primary Purpose
Stroke
Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
Sponsored by
About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- stroke (1-3 months)
- Brunnstrom Stage II-III
- single, unilateral
Exclusion Criteria:
- aphasic
- shoulder impairment
- severe osteoporosis
Sites / Locations
- Dpt. Physical Medicine and Rehabilitation, NTUHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
shoulder training, rehabilitation robot
control group
Arm Description
Outcomes
Primary Outcome Measures
Barthel index,
Modified Asworth Scale
STREAM and PASS scales
Secondary Outcome Measures
shoulder range of motion, VAS
Full Information
NCT ID
NCT01117194
First Posted
January 18, 2010
Last Updated
December 20, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01117194
Brief Title
Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
Official Title
Rehabilitation Robot for Upper Limbs, Component Project 5: Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
shoulder training, rehabilitation robot
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)
Other Intervention Name(s)
self-developed robotic arm
Intervention Description
Use an intelligent robot to assist upper limb rehabilitation.
Primary Outcome Measure Information:
Title
Barthel index,
Time Frame
1 year
Title
Modified Asworth Scale
Time Frame
1 year
Title
STREAM and PASS scales
Time Frame
1 year
Secondary Outcome Measure Information:
Title
shoulder range of motion, VAS
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
stroke (1-3 months)
Brunnstrom Stage II-III
single, unilateral
Exclusion Criteria:
aphasic
shoulder impairment
severe osteoporosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Shiang Chen
Phone
+886-2-2123456
Ext
67087
Email
wenshiang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Shiang Chen, MD, PhD
Organizational Affiliation
Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt. Physical Medicine and Rehabilitation, NTUH
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Shiang Chen
Phone
+886-2-2123456
Ext
67087
Email
wenshiang@gmail.com
First Name & Middle Initial & Last Name & Degree
Wen-Shiang Chen, MD PhD
12. IPD Sharing Statement
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Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
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