Main
|
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: |
|
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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|