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

Primary Purpose

Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke), Age Between 18-75 Years

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
WII Rehabilitation
Traditional rehabilitation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke) focused on measuring Hemiparesis,, Rehabilitation,, WII,, Upper limb,, Movement strategies.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Djamel Bensmail

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rehabilitation using Nintendo-Wii

Traditional physiotherapy

Arm Description

30 patients will receive rehabilitation using Nintendo-Wii.

30 patients will receive traditional physiotherapy.

Outcomes

Primary Outcome Measures

Degree of elbow extension during an active reaching task

Secondary Outcome Measures

Clinical
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
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
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'
The number and extent of the movements made with the upper limb during 'wii rehabilitation' will be recorded using accelerometers.
MRI
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.

Full Information

First Posted
March 6, 2013
Last Updated
November 17, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01806883
Brief Title
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
Acronym
WII
Official Title
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke), Age Between 18-75 Years
Keywords
Hemiparesis,, Rehabilitation,, WII,, Upper limb,, Movement strategies.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation using Nintendo-Wii
Arm Type
Experimental
Arm Description
30 patients will receive rehabilitation using Nintendo-Wii.
Arm Title
Traditional physiotherapy
Arm Type
Active Comparator
Arm Description
30 patients will receive traditional physiotherapy.
Intervention Type
Behavioral
Intervention Name(s)
WII Rehabilitation
Intervention Description
30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects.
Intervention Type
Behavioral
Intervention Name(s)
Traditional rehabilitation
Intervention Description
30 patients will receive the traditional rehabilitation.
Primary Outcome Measure Information:
Title
Degree of elbow extension during an active reaching task
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Clinical
Description
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)
Time Frame
1 hour and half
Title
Kinematic measures
Description
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)
Time Frame
45 minutes
Title
Kinetic measures
Description
Capacity to regulate grip force during a visuo-motor task using an instrumented device. (evaluated before and after the rehabilitation period)
Time Frame
45 minutes
Title
Movement strategies during 'Wii rehabilitation'
Description
The number and extent of the movements made with the upper limb during 'wii rehabilitation' will be recorded using accelerometers.
Time Frame
45 minutes
Title
MRI
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djamel Bensmail, MD
Organizational Affiliation
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Djamel Bensmail
City
Garches
State/Province
Hauts-de-Seine
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34929355
Citation
Teremetz M, Garcia Alvarez A, Hanneton S, Roby-Brami A, Roche N, Bensmail D, Lindberg P, Robertson JVG. Improving upper-limb and trunk kinematics by interactive gaming in individuals with chronic stroke: A single-blinded RCT. Ann Phys Rehabil Med. 2022 May;65(3):101622. doi: 10.1016/j.rehab.2021.101622. Epub 2022 Feb 26.
Results Reference
derived

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

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