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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02485171
Acronym
SAFEER
Enrollment
20
Registered
2015-06-30
Start date
2015-06-10
Completion date
2017-02-01
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-fall Syndrome

Brief summary

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

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.

Interventions

DEVICESAFEWALKER

Medical device walking aids.

Sponsors

Safe Step and Walk Movement (SSWM), Toulouse, France
CollaboratorUNKNOWN
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of SafewalkerDay 14Number of steps performed at each of the rehabilitation sessions A composite measure based on questionnaires assessing the feasibility (patient and therapist).
Acceptability of SafewalkerDay 14A composite measure based on questionnaires assessing the acceptability (patient and therapist).

Secondary

MeasureTime frameDescription
Step lengthDay 14This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).
Number of falls during the studyDay 14The nurse will report the number of times that the patient fell during his hospitalization
Walking speedDay 14This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).
Independence in basic activities of daily livingDay 14Using the Activities of Daily Living scale
The fear of fallingDay 14Using the Falls Efficacy Scale International
Quality of lifeDay 14Using the Short Form 36 scale
Retropulsion degreeDay 14This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026