The Balance and Foot Health Program for Older Adults: A Randomized Study

NCT07758764 | Not Yet Recruiting

• 2 other identifiers: RIPH2_FUNDENBERGER_PREPAS2026-A01073-48
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 20

Brief Summary

Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations. The primary objective of this study is to compare the effectiveness of adding 12 weekly foot health workshops to balance workshops on mobility among older adults living in nursing homes, compared to a program based exclusively on balance workshops.

Conditions

Fall Prevention

Outcome Measures

Primary Outcomes (1)

• The change in the Timed Up and Go test time, expressed in seconds

  The Timed Up and Go is a commonly used screening tool to assess mobility in older adults. The participant must stand up from a chair, walk a distance of three meters, turn around, then walk back to the chair and sit down. These tasks must be performed in a comfortable and safe pace. A practice trial is allowed to help the individual become familiar with the task. The individual wears their usual shoes. The use of a walking aid is permitted, but its use must be noted on the data collection form. No physical assistance is provided. The TUG is also sensitive to changes, detecting improvements or deteriorations in functional mobility. It has high validity, being able to correctly identify fallers and non-fallers with a sensitivity and specificity of 87%. Finally, this test is accurate, simple to administer, and useful for assessing functional mobility, particularly in older or medically compromised populations.

  at baseline assessment (T0) and after the 12 intervention sessions (T1)

Secondary Outcomes (9)

• Changes in the position of the center of pressure during static stance

  at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).

• Changes in the muscle strength of the flexors of the big toes (hallux)

  at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).

• Changes in ankle joint range of motion during dorsiflexion and plantar flexion

  at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).

• Changes in participants' fear of falling

  at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).

• Changes in foot pain experienced while walking

  at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the intervention group will attend weekly workshops as part of the Foot Health program (12 sessions), led by a mobile nurse trained in massage. The mobile nurse will perform all massages and lead the foot health workshops for all participants in the intervention group. Her status as a healthcare professional ensures the safety of the intervention. In addition, she is trained in wellness massage techniques. Participants will also take part in 12 workshops focused on balance, led by a professional in adapted physical activity. This workshop will include recommended strength training and balance exercises.

Other: Weekly foot health workshops; Other: Balance Workshops

Control group

ACTIVE COMPARATOR

The control group will participate only in 24 balance workshops. Balance workshops have been developed over the past decade to improve the independence of nursing home residents. However, their implementation varies widely from one facility to another, with differences in content, frequency, and instructors. This variability underscores the need to establish a common framework to ensure the comparability of interventions in a research setting.

Other: Balance Workshops

Interventions

Weekly foot health workshops OTHER

Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture, 12 workshops are planned, every week.

Experimental Group

Balance Workshops OTHER

Participants will take part in 12 balance workshops following a standardized format, including warm-up exercises, static and dynamic balance exercises, and functional strength training.

Control group; Experimental Group

Eligibility Criteria

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

You may qualify if:

• People aged 65 and older.
• Residents of nursing homes.
• Able to walk, with or without a walking aid (cane, walker, etc.)
• Residents at risk of falling, defined by at least one of the following criteria: history of a fall within the last 12 months; unsteadiness while walking or balance issues; limited mobility.
• Able to understand and follow simple instructions.
• Able to participate in workshops.
• Enrolled in a social security program or beneficiaries of an equivalent program.
• Individuals (participants, guardians, or conservators, as applicable) who have been informed and have provided written consent for their participation in the study.

You may not qualify if:

• \- Regular use of minimalist shoes at the time of enrollment.
• Medical condition or clinical situation contraindicating the use of minimalist shoes, as determined by the investigator.
• Use of orthopedic shoes prescribed by a healthcare professional.
• Unhealed foot wound or active foot infection.
• Recent lower limb fracture (\< 3 months) or recent lower limb trauma, likely to limit participation in the workshops or contraindicate foot mobilization, as assessed by the investigator.
• Severe cognitive impairment preventing the understanding of simple instructions or participation in the workshops.
• Any other clinical condition deemed incompatible with participation in the study by the investigator.

Sponsors & Collaborators

• Centre Hospitalier Emile Roux: lead

Study Sites (20)

EHPAD " Les 2 Volcans"

Allègre, 43270, France

Location

EHPAD "Foyer Notre-Dame"

Beaulieu, 43800, France

Location

EHPAD "Bon secours"

Beauzac, 43590, France

Location

EHPAD "Vert Bocage"

Brives-Charensac, 43700, France

Location

EHPAD "Sainte Monique"

Coubon, 43700, France

Location

EHPAD "Saint Dominique"

Craponne-sur-Arzon, 43500, France

Location

EHPAD Centre Hospitalier du Pays De Craponne

Craponne-sur-Arzon, 43500, France

Location

EHPAD "Le grand pré "

Lantriac, 43260, France

Location

EHPAD "Les Terrasses de la Gazeille"

Le Monastier-sur-Gazeille, 43150, France

Location

EHPAD "Bel Horizon"

Le Puy-en-Velay, 43000, France

Location

EHPAD "Les Patios du Velay"

Le Puy-en-Velay, 43000, France

Location

EHPAD "L'Age d'Or"

Monistrol-sur-Loire, 43120, France

Location

EHPAD "Résidence des Bords de Loire"

Retournac, 43130, France

Location

EHPAD "Résidence La Roseraie"

Rosières, 43800, France

Location

EHPAD "la Tortue"

Saint-Julien-Chapteuil, 43260, France

Location

EHPAD "l'Orangeraie"

Saint-Maurice-de-Lignon, 43200, France

Location

EHPAD "Résidence Ruessium"

Saint-Paulien, 43350, France

Location

EHPAD "Résidence Sainte Sigolène"

Sainte-Sigolène, 43600, France

Location

EHPAD "Foyer Bon Accueil"

Solignac-sur-Loire, 43370, France

Location

EHPAD "Foyer Marie Goy"

Vorey, 43800, France

Location

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: August 3, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)