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

NCT ID: NCT02485171

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2017-02-01

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.

Conditions

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Post-fall Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Introduction of a walking aid device SAFEWALKER for elderly patients during rehabilitation after a post-fall syndrome.

Group Type EXPERIMENTAL

SAFEWALKER

Intervention Type DEVICE

Medical device walking aids.

No intervention

No introduction of a walking aid device for elderly patients during rehabilitation after a post-fall syndrome.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SAFEWALKER

Medical device walking aids.

Intervention Type DEVICE

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)
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Safe Step and Walk Movement (SSWM), Toulouse, France

UNKNOWN

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fatemeh NOURHASHEMI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Nourhashemi Fatemeh

Toulouse, MIDI Pyrenees, France

Site Status

Countries

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France

References

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Piau A, Krams T, Voisin T, Lepage B, Nourhashemi F. Use of a robotic walking aid in rehabilitation to reduce fear of falling is feasible and acceptable from the end user's perspective: A randomised comparative study. Maturitas. 2019 Feb;120:40-46. doi: 10.1016/j.maturitas.2018.11.008. Epub 2018 Nov 17.

Reference Type RESULT
PMID: 30583763 (View on PubMed)

Other Identifiers

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RC31/14/7420

Identifier Type: -

Identifier Source: org_study_id

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