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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedDecember 10, 2025
May 1, 2018
1.6 years
June 11, 2015
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Walking speed
Day 14
Retropulsion degree
Day 14
Step length
Day 14
Number of falls during the study
Day 14
Quality of life
Day 14
- +2 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALIntroduction of a walking aid device SAFEWALKER for elderly patients during rehabilitation after a post-fall syndrome.
No intervention
NO INTERVENTIONNo introduction of a walking aid device for elderly patients during rehabilitation after a post-fall syndrome.
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalized for the treatment of post-fall syndrome
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nourhashemi Fatemeh
Toulouse, MIDI Pyrenees, 31052, France
Related Publications (1)
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.
PMID: 30583763RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Fatemeh NOURHASHEMI
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 30, 2015
Study Start
June 10, 2015
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
December 10, 2025
Record last verified: 2018-05