Evaluation of the Arm Rehabilitation Device for Patients With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698605
• Other study ID #: 101-5038A3
• Status: Completed
• Phase: N/A
• First received: February 13, 2016
• Last updated: March 14, 2016
• Start date: August 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Had previous experience using rehabilitation equipment.

Exclusion Criteria:

• Cognitive deficits or psychiatric illness.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	TaoYuan county

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes