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Clinical Trials/NCT02485171
NCT02485171
Completed
Not Applicable

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

University Hospital, Toulouse1 site in 1 country20 target enrollmentJune 10, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-fall Syndrome
Sponsor
University Hospital, Toulouse
Enrollment
20
Locations
1
Primary Endpoint
Acceptability of Safewalker
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2015
End Date
February 1, 2017
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Acceptability of Safewalker

Time Frame: Day 14

A composite measure based on questionnaires assessing the acceptability (patient and therapist).

Feasibility of Safewalker

Time Frame: Day 14

Number of steps performed at each of the rehabilitation sessions A composite measure based on questionnaires assessing the feasibility (patient and therapist).

Secondary Outcomes

  • Number of falls during the study(Day 14)
  • Step length(Day 14)
  • Quality of life(Day 14)
  • Independence in basic activities of daily living(Day 14)
  • The fear of falling(Day 14)
  • Walking speed(Day 14)
  • Retropulsion degree(Day 14)

Study Sites (1)

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