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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806883
First Posted: March 7, 2013
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]

Secondary Outcome Measures:
  • Clinical [ Time Frame: 1 hour and half ]
    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 ]
    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 ]
    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 ]
    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 ]

    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.



Enrollment: 57
Actual Study Start Date: January 2013
Study Completion Date: June 2017
Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806883


Locations
France
Djamel Bensmail
Garches, Hauts-de-Seine, France, 92380
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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01806883     History of Changes
Other Study ID Numbers: P110701
First Submitted: March 6, 2013
First Posted: March 7, 2013
Last Update Posted: November 20, 2017
Last Verified: November 2017

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

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