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Completed

NCT Number: NCT01806883

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.

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Key information

Conditions

Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke) Age Between 18-75 Years Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Djamel Bensmail

Garches, Hauts-de-Seine, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WII Rehabilitation

Behavioral

30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects.

Traditional Rehabilitation

Behavioral

30 patients will receive the traditional rehabilitation.

Primary outcomes

  1. Degree of elbow extension during an active reaching task

    Time frame: 6 minutes

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: WII

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 7, 2013
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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