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Evaluation of the Arm Rehabilitation Device for Patients With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698605
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Alice May-Kuen Wong, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Usability test study of the MirrorPath Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Design and Usability Evaluation of a Novel Robotic Bilateral Arm Rehabilitation Device for Patients With Stroke
Study Start Date : August 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Had previous experience using rehabilitation equipment.

Exclusion Criteria:

  • Cognitive deficits or psychiatric illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698605


Locations
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Taiwan
Chang Gung Memorial Hospital
TaoYuan county, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Alice M Wong, MD Chang Gung Memorial Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alice May-Kuen Wong, Attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02698605    
Other Study ID Numbers: 101-5038A3
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases