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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-fall Syndrome
• Intervention / Treatment: Device: SAFEWALKER

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • MIDI Pyrenees
    • Toulouse, MIDI Pyrenees, France, 31052
      • Nourhashemi Fatemeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Safe Step and Walk Movement (SSWM), Toulouse, France
• Investigators: Principal Investigator: Fatemeh NOURHASHEMI, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimated): June 30, 2015

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: RC31/14/7420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No