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Clinical Trials/NCT02698605
NCT02698605
Completed
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country17 target enrollmentAugust 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Chang Gung Memorial Hospital
Enrollment
17
Locations
1
Primary Endpoint
The system usability scale (SUS)
Status
Completed
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Alice May-Kuen Wong

Attending physician

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • Had previous experience using rehabilitation equipment.

Exclusion Criteria

  • Cognitive deficits or psychiatric illness.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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