Evaluation of the Arm Rehabilitation Device for Patients With Stroke
Design and Usability Evaluation of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients With Stroke
1 other identifier
interventional
17
1 country
1
Brief Summary
The usability assessment focuses on the actual use of the proposed rehabilitation system to clarify issues users would face in actual system operation, thus providing a reference for subsequent system improvement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2013
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
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 13, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedMarch 15, 2016
March 1, 2016
2.4 years
February 13, 2016
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The system usability scale (SUS)
Up to twenty subjects with their age ranging from 20 years to 70 years are planned to recruit for the one-time SUS. Categorizing the SUS questionnaire items in relation to usability (Q1, Q2, Q3, Q5, Q6, Q7, Q8, Q9) and learning (Q4, Q10) domains.
Up to 2 year
Study Arms (1)
Usability test study of the MirrorPath
EXPERIMENTALThis study was a one-arm study and all subjects used the device and received usability test.
Interventions
The study was conducted by research assistants. Each subject received one assessment that last lasted 30 minutes. The subjects were not paid for participation. In that, no randomization or masking were performed. Prior to the experiment part of the study, the subjects provided basic biographical information. We then explained the experimental process and demonstrated the operation of the device. A novel rehabilitation device, the MirrorPath, designed for the upper limb rehabilitation of patients with hemiplegic stroke. The MirrorPath that was 1180x440x300mm in size and had a shell was constructed of acrylonitrile butadiene styrene (ABS). The control module featured an on/off switch, a knob for adjusting the speed, and an emergency cutoff switch.
Eligibility Criteria
You may qualify if:
- Had previous experience using rehabilitation equipment.
You may not qualify if:
- Cognitive deficits or psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Related Publications (1)
Pei YC, Chen JL, Wong AMK, Tseng KC. An Evaluation of the Design and Usability of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients with Stroke. Front Neurorobot. 2017 Jul 28;11:36. doi: 10.3389/fnbot.2017.00036. eCollection 2017.
PMID: 28804454DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice M Wong, MD
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
February 13, 2016
First Posted
March 3, 2016
Study Start
August 1, 2013
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
March 15, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share