Backward Walking Rehabilitation to Prevent Falls in High-risk Adults Aged 75 Years and Older

NCT07650097 | Not Yet Recruiting

• 2 other identifiers: APHP2512452025-A02896-43
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Falls are a major health problem for people over 75 years old. Backward walking may strengthen the muscles of the legs, improve posture and balance, and make walking more stable, which could help prevent new falls and improve everyday movement. This is an open-label, multicenter, randomized controlled trial that will examine whether backward walking, integrated to usual rehabilitation in a geriatric day hospital program, can help reduce the number of new falls in older adult at high risk of falling. About 300 people aged over 75 years, living at home and at high risk of falling, will be included in this trial in 11 geriatric day hospitals in France. After receiving appropriate information, those who agree to participate will sign a written consent form and will then be randomly assigned to one of two groups. Both groups will receive standard rehabilitation care in the geriatric day hospital, with two rehabilitation sessions per week for 12 weeks. In the control group, patients will only receive usual care to prevent falls previously described above. In the intervention group, part of the usual care will be replaced, for 5 weeks, by supervised backward walking exercises, with the goal of doing two effective 10 minute backward walking sessions per week, without increasing the total time spent in rehabilitation. The trial will be conducted under the intention-to-treat principle. Participants will have a clinical visit at day 0, at week 5 and at 6 months, during which clinical information and data related to their usual care and to the study will be collected. All participants will be followed for a total of 12 months, with monthly phone calls from a study team member to record any new falls, hospitalizations, health problems, or other important events. For 10 patients in the intervention group, an individual interview will also be carried out at the 5 week visit to better understand their experience of backward walking. 2 focus groups will be held with 2 randomly selected centers to identify barriers and facilitators to the implementation of backward walking sessions. This study aims to determine whether adding backward walking to standard rehabilitation is a safe, acceptable and effective way to prevent falls in older adults at high risk of falling.

Conditions

High Risk of Falling

Keywords

Fall; Geriatrics; Walking backwards

Outcome Measures

Primary Outcomes (1)

• Number of falls per patient between inclusion and one year of follow-up including rehabilitation period in a geriatric day hospital

  Number of falls per patient

  12 months after inclusion

Secondary Outcomes (15)

• Balance assessment

  At inclusion, Week 5 and 6 months

• Assessment of walking speed

  At inclusion, Week 5 and 6 months

• Measuring fear of falling

  At inclusion, Week 5 and 6 months

• Assessment of functional mobility

  At inclusion, Week 5 and 6 months

• Time to first fall in days

  From inclusion to 12 months (monthly)

Study Arms (2)

Walking backwards

EXPERIMENTAL

Other: Walking backwards

Usual walking

ACTIVE COMPARATOR

Other: Usual walking

Interventions

Walking backwards OTHER

Standard care combined with rehabilitation sessions involving walking backwards. Ten rehabilitation sessions involving walking backwards are scheduled, at a rate of two sessions per week for five weeks, on a secure treadmill designed for walking backwards. Walking backwards will not add to the rehabilitation time; it will replace standard care to allow for two 10-minute sessions of actual walking backwards per week. Walking backwards are integrated to the 12 weeks standard program.

Walking backwards

Usual walking OTHER

The standard program runs for 12 weeks, with sessions twice a week, comprising two 45-minute activities per day. At least one session per week must include balance training, muscle strengthening and multi-modal exercises. The treadmill may be used for these activities, but only for walking forwards.

Usual walking

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• People aged over 75
• Consultant at a geriatric day hospital
• At high risk of falling. High risk of falling is defined in accordance with the World guidelines for falls prevention and management for older adults: a global initiative. The patient must have at least one of the following characteristics:
• At least two falls in the last 12 months;
• A fall resulting in an injury requiring medical attention;
• Inability to get up unaided after a fall for at least one hour;
• Suspected syncope;
• Frailty (Clinical Frailty Scale ≥4)
• Able to walk on a treadmill (physically able and capable of understanding the physiotherapist's instructions)
• Able to understand and follow instructions from healthcare professionals
• Patient or guardian who has been informed about the study and has given their free, informed and written consent to participate
• Covered by a social security scheme (member or beneficiary) excluding Aide Médicale d'Etat (AME).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Charles-Foix

Ivry-sur-Seine, 94205, France

Location

Study Officials

• Bruno OQUENDO, Dr

  Hôpital Charles-Foix - Assistance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno OQUENDO, Dr

CONTACT

01 49 59 43 53; bruno.oquendo@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): March 15, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)