Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke)WIINCT01806883
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
A study testing WII Rehabilitation and Traditional rehabilitation in people with Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke) and Age Between 18-75 Years, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke), Age Between 18-75 Years
- What is being tested?
- WII Rehabilitation and Traditional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major cognitive or perceptive deficits Cerebellar syndrome Epileptic fits within the previous year Pacemaker user Un-corrected visual deficits No social security
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- WII Rehabilitation, Traditional rehabilitation
- Keywords
- Hemiparesis,, Rehabilitation,, WII,, Upper limb,, Movement strategies.
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WII RehabilitationBehavioural
30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects.
Traditional rehabilitationBehavioural
30 patients will receive the traditional rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation using Nintendo-Wii | Experimental | 30 patients will receive rehabilitation using Nintendo-Wii. Receives: Behavioral: WII Rehabilitation |
| Traditional physiotherapy | Active comparator | 30 patients will receive traditional physiotherapy. Receives: Behavioral: Traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of elbow extension during an active reaching task
Measured: 6 minutes
Secondary outcomes (5)
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)
Measured: 1 hour and half
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)
Measured: 45 minutes
Kinetic measures
Capacity to regulate grip force during a visuo-motor task using an instrumented device. (evaluated before and after the rehabilitation period)
Measured: 45 minutes
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.
Measured: 45 minutes
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Djamel Bensmail, MD, Principal investigator, Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806883
- Sponsor's protocol ID
- P110701
- Acronym
- WII
- Status last verified
- Nov 2017
- First submitted
- 6 Mar 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34929355
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
- ClinicalTrials.gov ID
- NCT01806883
- Acronym / sponsor ID
- WII / P110701
- Keywords
- Hemiparesis,, Rehabilitation,, WII,, Upper limb,, Movement strategies.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation using Nintendo-Wii | Experimental | Behavioral: WII Rehabilitation30 patients will receive rehabilitation using Nintendo-Wii. |
| Traditional physiotherapy | Active comparator | Behavioral: Traditional rehabilitation30 patients will receive traditional physiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Major cognitive or perceptive deficits Cerebellar syndrome Epileptic fits within the previous year Pacemaker user Un-corrected visual deficits No social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WII Rehabilitation30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects. | Behavioural | Rehabilitation using Nintendo-Wii |
| Traditional rehabilitation30 patients will receive the traditional rehabilitation. | Behavioural | Traditional physiotherapy |
Primary outcome
Degree of elbow extension during an active reaching task
Time frame: 6 minutes
5 secondary outcomes
Clinical
Time frame: 1 hour and half
Kinematic measures
Time frame: 45 minutes
Kinetic measures
Time frame: 45 minutes
Movement strategies during 'Wii rehabilitation'
Time frame: 45 minutes
MRI
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Derived from this study: PubMed 34929355Teremetz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamel Bensmail, MD principal investigator
Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WII Rehabilitation and Traditional rehabilitation in people with Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke) and Age Between 18-75 Years, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of elbow extension during an active reaching task (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.