NCT03229733

Brief Summary

The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 18, 2018

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

July 23, 2017

Last Update Submit

July 17, 2018

Conditions

Stroke

Keywords

StrokeKinectRehabilitationUpper limbs

Outcome Measures

Primary Outcomes (1)

  • Motor function assessed on Fugl-Meyer Assessment (FMA)

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

    Change from baseline at 5 months

Secondary Outcomes (7)

  • The amount of movement assessed on Actigraph Assessment

    Change from baseline at 2 months

  • The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)

    Change from baseline at 5 months

  • The quality of movement and amount of use assessed on Motor Activity Log (MAL)

    Change from baseline at 5 months

  • The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)

    Change from baseline at 5 months

  • The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)

    Change from baseline at 5 months

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.

Device: KinectBehavioral: Traditional occupational therapy

Control group

ACTIVE COMPARATOR

Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar.

Behavioral: Traditional occupational therapy

Interventions

KinectDEVICE

Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks

Experimental group
Traditional occupational therapyBEHAVIORAL

Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.

Control groupExperimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment
  • months post stroke
  • Impaired arm motor function at Brunnstrom stage 3-5
  • Age 18 years or older

You may not qualify if:

  • severe cognitive impairment defined as \< 20 on Mini Mental State Examination
  • visual disorders or neglect limiting the ability to comply with treatment regimen
  • orthopedic problem or other neurological diagnosis that makes the UE dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.

    PMID: 25297823RESULT

  • Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.

    PMID: 25265612RESULT

  • Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.

    PMID: 11441212RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jen-Wen Hung

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 25, 2017

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 18, 2018

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share