Study of the Impact of Implicit Motor Training in a Rehabilitation Programme in Frail Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Rehabilitation Frail Elderly Subjects

Intervention / Treatment
-----------------
* Other: serious game et virtual reality
* Other: Nintendo Wii


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: serious game<br> | Other: serious game et virtual reality<br> <br> |
| Placebo Comparator: control<br> | Other: Nintendo Wii<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Change from baseline at Day0 and after 6 weeks of training |