- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02855853
Study of the Impact of Implicit Motor Training in a Rehabilitation Programme in Frail Elderly Subjects (MAAMI)
Study of the Impact of Implicit Motor Training Using a Virtual Reality System and Serious Games on a Tablet Computer in a Rehabilitation Programme in Frail Elderly Subjects
Even though cognitive-motor performances are impaired in frail elderly subjects compared with healthy elderly subjects, exercising cognitive-motor processes in an implicit manner can improve the carrying out of real actions in everyday life.
No training programme using virtual reality and serious games oriented towards the perception/action system has been tested in frail elderly subjects.
The expected results are:
- In the short term, greater strengthening of motor and cognitive abilities in subjects trained with the virtual reality and serious games, thanks to stimulation through action and through the underlying processes.
- In the long term (+1 and +3 months at the end of the training period) better preservation of motor and cognitive abilities in subjects who took part in the virtual reality and serious games programme.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Dijon, France, 21079
- Chu Dijon Bourgogne
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients :
- Who have provided oral consent
- Enrolled in a geriatric rehabilitation programme
- Qualified as cognitively frail, that is to say a MiniMental State Examination (MMSE) score between 15 and 28 and/or for motor abilities, a walking speed less than 0.65 m/s.
- Aged ≥ 65 years
- Able to understand simple instructions
Exclusion Criteria:
Patients:
- Not covered by national health insurance
- With an extremely low cognitive status (MMSE < 15)
- With severely impaired vision and audition (unable to discern any sensory information from the virtual reality system: music, sounds, images)
- Who are unstable when standing
- With an unsteady gait (risk of falling)
- Who cannot walk at least 10 metres
- With an acute non-stabilized cardiovascular disease
- With one or several non-consolidated fractures.
- Under guardianship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control
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Experimental: serious game
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Improvement in performance at the Timed Up and Go (TUG) in the group taking part in the implicit motor training programme compared with a group having conventional motor training.
Time Frame: Change from baseline at Day0 and after 6 weeks of training
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Change from baseline at Day0 and after 6 weeks of training
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MANCKOUNDIA ANR 2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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