- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066116
Kinect-based Upper Limb Rehabilitation System in Stroke Patients
Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinect-based Rehabilitation
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The developed kinect-based rehabilitation system will be used for 30min/session.
Conventional 30min occupational therapy also will be applied for the patient enrolled.
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Active Comparator: Self-exercises education
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks
Time Frame: Baseline, 2 weeks after the baseline
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Baseline, 2 weeks after the baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brunnstrom stage
Time Frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
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This is composed of 6 stages. Higher score means better function. The description for each stage as follows.
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Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
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Modified Barthel Index
Time Frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
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Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
|
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Box and Block Test
Time Frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
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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
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Number of movement counts during rehabilitation using accelerometer data
Time Frame: Baseline, 2 weeks after the baseline
|
Baseline, 2 weeks after the baseline
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1401-234-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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