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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 9 May 2016
Main ID:  NCT02759328
Date of registration: 28/04/2016
Prospective Registration: No
Primary sponsor: Ankara University
Public title: Xbox Kinect™ Training for Stroke Rehabilitation
Scientific title: Clinical Feasibility of the Xbox Kinect™ Training for Stroke Rehabilitation: a Single Blind Randomized Controlled Pilot Study
Date of first enrolment: December 2012
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02759328
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Turkey
Contacts
Name:     Haydar GOK, Professor
Address: 
Telephone:
Email:
Affiliation:  Ankara University
Key inclusion & exclusion criteria

Inclusion Criteria:

- First-time ischemic or hemorrhagic stroke occurring in the last 9 months

- Between 18 and 80 years of age

- Brunnstrom motor recovery stage in the affected upper extremity = 3

- Ability to understand and follow simple explanations and commands

- Mini-Mental State Examination score of = 24

Exclusion Criteria:

- History of epilepsy or seizure (except childhood febrile seizures)

- Arthritis or pain restricting the repetitive training of the affected upper extremity

- Severe aphasia

- Neglect phenomena

- Cognitive or psychiatric disorders

- = Grade 3 spasticity in the affected upper extremity according to Modified Ashworth
Scale

- Medical conditions which may affect physical performance or the physical activity may
become unsafe (unstable angina, myocardial infarction within the last 3 months,
uncontrolled blood pressure, pulmonary disease, etc.)

- Participation in another clinical trial



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Stroke
Intervention(s)
Behavioral: Conventional rehabilitation
Behavioral: Xbox Kinect™ training
Primary Outcome(s)
Treatment attendance ratios [Time Frame: Every training session during 4 weeks (total 20 sessions)]
Number of patients with adverse events [Time Frame: Every training session during 4 weeks (total 20 sessions)]
Secondary Outcome(s)
Brunnstrom Motor Assessment Scale [Time Frame: Change from baseline at 4 weeks]
Wolf Motor Function Test [Time Frame: Change from baseline at 4 weeks]
Borg 10 Point Scale [Time Frame: Every training session during 4 weeks (total 20 sessions)]
Functional Independence Measure [Time Frame: Change from baseline at 4 weeks]
Patient feedback survey [Time Frame: At 4 weeks (after completion of all treatment sessions (total 20 sessions))]
Box and Blocks Test [Time Frame: Change from baseline at 4 weeks]
Secondary ID(s)
20-645-12
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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