SAFEWALKER Contribution to the Rehabilitation of Older People After a Post-fall Syndrome

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the feasibility and acceptability of the use of the robot SAFEWALKER complement classical rehabilitation in a group of elderly patients over 70 years during the rehabilitation of post-fall syndrome.

Detailed Description
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The post-fall syndrome is an acute functional complications of falls that affects nearly one in five elderly fallers. It combines phobia of the previous vacuum, axial and hypertension astasia abasia. Unrecognized and untreated, it progresses to a major regressive syndrome, severe physical, psychological and social implications. Only an early rehabilitation for an early resumption of walking, prevents such a development. The main element is to support and encourage the subject to walking. In practice, it was found that the physiotherapist can not be present daily and the duration of its intervention is often short-lived. This study will examine the contribution of a medical device of a walking aid (SAFEWALKER the robot) in the rehabilitation and empowerment of seniors with a post-fall syndrome. The SAFEWALKER, which is a walking aid device (http://www.safewalker.com), completes the support action exercised by a third person, by reducing support and securing travel. It allows the subject to move alone at will and is a continuity in relation to the management of the physiotherapist, a potential source of motivation. The hypothesis is that the SAFEWALKER device can be complementary to the walking rehabilitation in post-fall syndrome.

Official Title
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Post-fall Syndrome of the Aged Person : Contribution of SAFEWALKER for Rehabilitation

Conditions
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Post-fall Syndrome

Intervention / Treatment
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* Device: SAFEWALKER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized for the treatment of post-fall syndrome Exclusion Criteria: Demential pathology (Mini Mental State <20) Parkinson's disease and other degenerative neurological disorders Stroke sequelae Fractures members in the previous 12 months Lower limb prostheses in place within 6 months prior Psychiatric disease Presence of mucocutaneous lesions perineal Obesity (weight >120 kg)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Introduction of a walking aid device SAFEWALKER for elderly patients during rehabilitation after a post-fall syndrome. | Device: SAFEWALKER<br>* Medical device walking aids.<br>|
| No Intervention: No intervention<br>No introduction of a walking aid device for elderly patients during rehabilitation after a post-fall syndrome. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Safewalker | Number of steps performed at each of the rehabilitation sessions A composite measure based on questionnaires assessing the feasibility (patient and therapist). | Day 14 | 
| Acceptability of Safewalker | A composite measure based on questionnaires assessing the acceptability (patient and therapist). | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed | This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®). | Day 14 | 
| Retropulsion degree | This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®). | Day 14 | 
| Step length | This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®). | Day 14 | 
| Number of falls during the study | The nurse will report the number of times that the patient fell during his hospitalization | Day 14 | 
| Quality of life | Using the Short Form 36 scale | Day 14 | 
| Independence in basic activities of daily living | Using the Activities of Daily Living scale | Day 14 | 
| The fear of falling | Using the Falls Efficacy Scale International | Day 14 |