Kinect-based Upper Limb Rehabilitation System in Stroke Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial

Conditions
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Stroke, Hemiplegia, Virtual Rehabilitation

Intervention / Treatment
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* Procedure: Kinect-based rehabilitation plus occupational therapy
* Other: sham virtual rehabilitation education plus occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 20 to 80 years Stroke within prior 3 months Unilateral upper extremity weakness Exclusion Criteria: Uncontrolled medical conditions Who cannot obey the simple command Who has the hemispatial neglect, visual impairment, apraxia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinect-based Rehabilitation<br> | Procedure: Kinect-based rehabilitation plus occupational therapy<br>* The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.<br>|
| Active Comparator: Self-exercises education<br> | Other: sham virtual rehabilitation education plus occupational therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks |  | Baseline, 2 weeks after the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brunnstrom stage | This is composed of 6 stages. Higher score means better function. The description for each stage as follows. Flaccidity: no voluntary movement. Synergies or minimal voluntary movement. Synergies performed voluntary (spasticity gratest). Some deviation from synergy. Independent or isolated movement. Individual joint movement nearly normal with minimal spasticity. | Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline | 
| Modified Barthel Index |  | Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline | 
| Box and Block Test | Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. | Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline | 
| Number of movement counts during rehabilitation using accelerometer data |  | Baseline, 2 weeks after the baseline |