Kinect-based Upper Limb Rehabilitation System in Stroke Patients

Terminated

Phase N/A Results N/A

Trial Description

The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.
In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.
20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.

Trial Stopped: enrollment is difficult and pilot nature of this study

Conditions

Interventions

  • Kinect-based rehabilitation plus occupational therapy Procedure
    Intervention Desc: The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.
    ARM 1: Kind: Experimental
    Label: Kinect-based Rehabilitation
  • Self-exercise education plus occupational therapy Other
    ARM 1: Kind: Experimental
    Label: Self-exercises education
  • Sham virtual rehabilitation education plus occupational therapy Other
    Intervention Desc: For the sham virtual rehabilitation, computer-based cognitive rehabilitation program will be used. Patients will be encouraged to use their affected arm to push the button but the motion will be minimal and not related to the concept of upper extremity rehabilitation.
    ARM 1: Kind: Experimental
    Label: Self-exercises education

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2weeks Baseline, 2 weeks after the baseline No
Secondary Brunnstrom stage Baseline, 2 weeks after the baseline, 6 weeks after the baseline No
Secondary Modified Barthel Index Baseline, 2 weeks after the baseline, 6 weeks after the baseline No
Secondary Box and Block Test Baseline, 2 weeks after the baseline, 6 weeks after the baseline No
Secondary Nubmer of movement counts during rehabilitation using accelerometer data Baseline, 2 weeks after the baseline, 6 weeks after the baseline No
Secondary Number of movement counts during rehabilitation using accelerometer data Baseline, 2 weeks after the baseline, 6 weeks after the baseline No
Primary Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks Baseline, 2 weeks after the baseline No

Sponsors