|
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:
|
16 December 2017 |
|
Main ID: |
NCT01806883 |
|
Date of registration:
|
06/03/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
WII |
|
Scientific title:
|
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients. |
|
Date of first enrolment:
|
January 2013 |
|
Target sample size:
|
57 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01806883 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Djamel Bensmail, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Age 18 to 75 years Right handed Hemiparesis following vascular lesions of a single
hemisphere of more than 6 months duration.
Not a regular 'Wii' user Able to bring the hand to the mouth. No botulinum toxin injections
within the previous 3 months Having given informed consent
Exclusion Criteria:
Major cognitive or perceptive deficits Cerebellar syndrome Epileptic fits within the
previous year Pacemaker user Un-corrected visual deficits No social security
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Age Between 18-75 Years
|
|
Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke)
|
|
Intervention(s)
|
|
Behavioral: Traditional rehabilitation
|
|
Behavioral: WII Rehabilitation
|
|
Primary Outcome(s)
|
|
Degree of elbow extension during an active reaching task
[Time Frame: 6 minutes]
|
|
Secondary Outcome(s)
|
|
Kinetic measures
[Time Frame: 45 minutes]
|
|
Clinical
[Time Frame: 1 hour and half]
|
|
Movement strategies during 'Wii rehabilitation'
[Time Frame: 45 minutes]
|
|
Kinematic measures
[Time Frame: 45 minutes]
|
|
MRI
[Time Frame: 1 hour]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|