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
  Purpose

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.


Condition Intervention
Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke)
Age Between 18-75 Years
Behavioral: WII Rehabilitation
Behavioral: Traditional rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Degree of elbow extension during an active reaching task [ Time Frame: 6 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation using Nintendo-Wii
30 patients will receive rehabilitation using Nintendo-Wii.
Behavioral: WII Rehabilitation
30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects.
Active Comparator: Traditional physiotherapy
30 patients will receive traditional physiotherapy.
Behavioral: Traditional rehabilitation
30 patients will receive the traditional rehabilitation.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806883

Locations
France
Djamel Bensmail Recruiting
Garches, Hauts-de-Seine, France, 92380
Contact: Djamel Bensmail, MD    00 33 1 47 10 70 60    djamel.bensmail@rpc.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Djamel Bensmail, MD Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01806883     History of Changes
Other Study ID Numbers: P110701
Study First Received: March 6, 2013
Last Updated: March 6, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hemiparesis,
Rehabilitation,
WII,
Upper limb,
Movement strategies.

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014