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

Post-fall Syndrome Clinical Trial

— SAFEER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485171
• Other study ID #: RC31/14/7420
• Status: Completed
• Phase: N/A
• Start date: June 10, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post-fall Syndrome
• Syndrome

Intervention

Device:
• SAFEWALKER
Medical device walking aids.

Locations

Country	Name	City	State
France	Nourhashemi Fatemeh	Toulouse	MIDI Pyrenees

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Safe Step and Walk Movement (SSWM), Toulouse, France

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. — View Citation

Büchele G, Becker C, Cameron ID, König 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability of Safewalker	A composite measure based on questionnaires assessing the acceptability (patient and therapist).	Day 14
Secondary	Walking speed	This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).	Day 14
Secondary	Retropulsion degree	This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).	Day 14
Secondary	Step length	This parameter will be collected by a pedometer (manual and electronic) and embedded soles (Dynafoot ®) and motion sensors (Bioval ®).	Day 14
Secondary	Number of falls during the study	The nurse will report the number of times that the patient fell during his hospitalization	Day 14
Secondary	Quality of life	Using the Short Form 36 scale	Day 14
Secondary	Independence in basic activities of daily living	Using the Activities of Daily Living scale	Day 14
Secondary	The fear of falling	Using the Falls Efficacy Scale International	Day 14