Evaluation of the Arm Rehabilitation Device for Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Usability test study of the MirrorPath
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)