Kinect-based Upper Limb Rehabilitation System in Stroke Patients

November 1, 2017 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: Kinect-based rehabilitation plus occupational therapy
The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.
Active Comparator: Self-exercises education
Other: sham virtual rehabilitation education plus occupational therapy
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.

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
Baseline, 2 weeks after the baseline

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

This is composed of 6 stages. Higher score means better function. The description for each stage as follows.

  1. Flaccidity: no voluntary movement.
  2. Synergies or minimal voluntary movement.
  3. Synergies performed voluntary (spasticity gratest).
  4. Some deviation from synergy.
  5. Independent or isolated movement.
  6. 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
Time Frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
Box and Block Test
Time Frame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline

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
Time Frame: Baseline, 2 weeks after the baseline
Baseline, 2 weeks after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Microsoft Research
The Ministry of Science, ICT and Future Planning, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 16, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

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)?

Undecided

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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