Clinical trial NCT02485171: SAFEWALKER Contribution to the Rehabilitation of Older People After a Post-fall Syndrome
Official title: Post-fall Syndrome of the Aged Person : Contribution of SAFEWALKER for Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-fall Syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Safe Step and Walk Movement (SSWM), Toulouse, France
First posted: 2015-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of Safewalker
timeFrame: Day 14
measure: Acceptability of Safewalker
timeFrame: Day 14
Secondary outcomes:
measure: Walking speed
timeFrame: Day 14
measure: Retropulsion degree
timeFrame: Day 14
measure: Step length
timeFrame: Day 14
measure: Number of falls during the study
timeFrame: Day 14
measure: Quality of life
timeFrame: Day 14
measure: Independence in basic activities of daily living
timeFrame: Day 14
measure: The fear of falling
timeFrame: Day 14
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Nourhashemi Fatemeh
state: MIDI Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: Fatemeh NOURHASHEMI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambrose AF, Paul G, Hausdorff JM. Risk factors for falls among older adults: a review of the literature. Maturitas. 2013 May;75(1):51-61. doi: 10.1016/j.maturitas.2013.02.009. Epub 2013 Mar 22.
citation: Buchele G, Becker C, Cameron ID, Konig HH, Robinovitch S, Rapp K. Predictors of serious consequences of falls in residential aged care: analysis of more than 70,000 falls from residents of Bavarian nursing homes. J Am Med Dir Assoc. 2014 Aug;15(8):559-63. doi: 10.1016/j.jamda.2014.03.015. Epub 2014 May 11.
citation: Cumming RG, Salkeld G, Thomas M, Szonyi G. Prospective study of the impact of fear of falling on activities of daily living, SF-36 scores, and nursing home admission. J Gerontol A Biol Sci Med Sci. 2000 May;55(5):M299-305. doi: 10.1093/gerona/55.5.m299.
citation: Denkinger MD, Lukas A, Nikolaus T, Hauer K. Factors associated with fear of falling and associated activity restriction in community-dwelling older adults: a systematic review. Am J Geriatr Psychiatry. 2015 Jan;23(1):72-86. doi: 10.1016/j.jagp.2014.03.002. Epub 2014 Mar 15.
citation: Evitt CP, Quigley PA. Fear of falling in older adults: a guide to its prevalence, risk factors, and consequences. Rehabil Nurs. 2004 Nov-Dec;29(6):207-10.