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Completed

NCT Number: NCT02485171

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

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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nourhashemi Fatemeh

Toulouse, MIDI Pyrenees, 31052, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SAFEWALKER

Device

Medical device walking aids.

Primary outcomes

  1. 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).

  2. Acceptability of Safewalker

    Time frame: Day 14

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

Secondary outcomes

  1. Walking speed

    Time frame: Day 14

    This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).

  2. Retropulsion degree

    Time frame: Day 14

    This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).

  3. Step length

    Time frame: Day 14

    This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).

  4. Number of falls during the study

    Time frame: Day 14

    The nurse will report the number of times that the patient fell during his hospitalization

  5. Quality of life

    Time frame: Day 14

    Using the Short Form 36 scale

  6. Independence in basic activities of daily living

    Time frame: Day 14

    Using the Activities of Daily Living scale

  7. The fear of falling

    Time frame: Day 14

    Using the Falls Efficacy Scale International

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SAFEER

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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