Evaluation of the Arm Rehabilitation Device for Patients With Stroke

March 14, 2016 updated by: Alice May-Kuen Wong, Chang Gung Memorial Hospital

Design and Usability Evaluation of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study protocol was approved by the institutional review board of Chang Gung Medical Foundation. 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. Pre-testing and formal testing were conducted at Chang Gung Memorial Hospital at Taoyuan. The pre-test was conducted on five healthy participants, while the formal testing was conducted on 12 participants (4 stroke patients, 4 caregivers, and 4 therapists). The healthy participants were aged 20-70 years old and had no physical disabilities; the stroke patients had normal cognitive and language skills, stable stroke status, no fractures in the upper limbs in the previous three months, and minimal or no upper limb spasticity with Modified Ashworth Scale of 0 or 1; the occupational therapists should had work experience in the hospital for more than one year.

Prior to the experiment, the subject provided basic biographical information. The investigators then explained the experimental process and demonstrated the operation of the device. For usability assessment, the subject operated the device under the instruction by the researchers, during which problems observed and questions asked were recorded. Following device operation, the subjects filled the system usability scale (SUS) questionnaire that obtained subjective evaluations and recommendations for the device. Experimental instrument consisted of the rehabilitation device, video cameras, still image cameras, digital voice recorders, questionnaires and observational recording forms.

The results of the SUS questionnaire were analyzed using SPSS (IBM Corp., Armonk, NY, USA). The split-half method was used for reliability analysis and one-sample t test for comparison.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • TaoYuan county, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Had previous experience using rehabilitation equipment.

Exclusion Criteria:

  • Cognitive deficits or psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usability test study of the MirrorPath
This study was a one-arm study and all subjects used the device and received usability test.
Device: Usability test study of the MirrorPath

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The system usability scale (SUS)
Time Frame: Up to 2 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Alice M Wong, MD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-5038A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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