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Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients. (WII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01806883
First received: March 6, 2013
Last updated: NA
Last verified: November 2012
History: No changes posted

March 6, 2013
March 6, 2013
January 2013
November 2015   (final data collection date for primary outcome measure)
Degree of elbow extension during an active reaching task [ Time Frame: 6 minutes ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Clinical [ Time Frame: 1 hour and half ] [ Designated as safety issue: Yes ]
    Pain (VAS) (evaluated at the beginning and end of each session) Borg scale of perceived effort (evaluated at the end of each session) Fugl-Meyer (upper limb section) (evaluated before and after the rehabilitation period) Box and Block test (evaluated before and after the rehabilitation period) Action Research Arm Test (ARAT) (evaluated before and after the rehabilitation period) Motor Activity Log (MAL) (evaluated before and after the rehabilitation period) Stroke Impact scale (SIS) (evaluated before and after the rehabilitation period) Satisfaction (VAS) (evaluated at the end of the rehabilitation period)
  • Kinematic measures [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]
    Parameters relating to hand trajectory (smoothness, curvature, velocity) and upper limb joint angles (trunk flexion, shoulder abduction) during an active reaching task using an electromagnetic motion capture system. (evaluated before and after the rehabilitation period)
  • Kinetic measures [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]
    Capacity to regulate grip force during a visuo-motor task using an instrumented device. (evaluated before and after the rehabilitation period)
  • Movement strategies during 'Wii rehabilitation' [ Time Frame: 45 minutes ] [ Designated as safety issue: Yes ]
    The number and extent of the movements made with the upper limb during 'wii rehabilitation' will be recorded using accelerometers.
  • MRI [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

    The extent and localization of the lesions will be evaluated using MRIcro and correlations will be sought between the lesion locations and the kinematic and kinetic characteristics of the patients.

    Evaluations will be carried out during the week preceding and the week following the rehabilitation period. The evaluating therapist will be blinded to the type of rehabilitation received by the patient.

Same as current
Not Provided
Not Provided
 
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.

The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb movement in chronic stroke patients following rehabilitation using the "Nintendo Wii". The investigators hypothesize that patients will increase their use of compensatory strategies following this rehabilitation.

The principal aim of this study is to evaluate changes in strategies of hemiparetic upper limb movement in chronic stroke patients following twelve one hour sessions of rehabilitation using the "Nintendo Wii" over a period of four weeks, and to compare with a group of patients receiving traditional upper limb rehabilitation of the same duration. The investigators hypothesize that the use of compensatory strategies will increase in the group receiving the "Wii" rehabilitation while they will decrease in the group receiving traditional rehabilitation. The investigators further hypothesize that this will have an impact on the functional benefit with a greater improvement of function in the group receiving traditional rehabilitation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke)
  • Age Between 18-75 Years
  • Behavioral: WII Rehabilitation
    30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects.
  • Behavioral: Traditional rehabilitation
    30 patients will receive the traditional rehabilitation.
  • Experimental: Rehabilitation using Nintendo-Wii
    30 patients will receive rehabilitation using Nintendo-Wii.
    Intervention: Behavioral: WII Rehabilitation
  • Active Comparator: Traditional physiotherapy
    30 patients will receive traditional physiotherapy.
    Intervention: Behavioral: Traditional rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2016
November 2015   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
Yes
France
 
NCT01806883
P110701
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Djamel Bensmail, MD Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Assistance Publique - Hôpitaux de Paris
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP