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.
The purpose of this multicenter cluster-randomized controlled trial is to evaluate whether a structured Foot Health Program combined with balance training improves functional outcomes in nursing home residents compared with balance training alone. Foot disorders are common among older adults living in nursing homes and may contribute to impaired balance, reduced mobility, loss of functional independence, and increased risk of falls. Interventions targeting foot health, sensory stimulation, foot mobility, and foot muscle strengthening may represent an innovative approach to complement conventional fall prevention strategies. This study aims to assess the added value of a multimodal foot-focused intervention when combined with a standardized balance training program. Twenty nursing homes (EHPADs) will participate in the study. Nursing homes will be randomized at the facility level in a 1:1 ratio to either the intervention group or the control group. Ten facilities will be allocated to the intervention group and ten facilities to the control group. A total of 200 participants will be enrolled, with approximately 10 residents recruited in each nursing home. Prior to enrollment, eligibility criteria will be assessed during a screening visit. Study information will be provided to participants and, when applicable, to their legal representative or trusted person. Written informed consent will be obtained before participation in any study procedures. At baseline (T0), demographic and clinical characteristics will be collected. All participants will undergo a podiatric assessment performed by a podiatrist involved in the study. Routine foot care will be provided when required. Baseline outcome assessments will be completed within 15 days before the first intervention session. Participants allocated to the intervention group will receive a structured Foot Health Program in addition to standardized balance workshops. The Foot Health Program consists of 12 weekly sessions delivered by a mobile nurse trained in foot massage techniques and foot health education. The intervention was developed and refined through a feasibility study and subsequently standardized to ensure reproducibility across participating nursing homes. The Foot Health Program is organized into three sequential phases. The first phase (sessions 1 to 3) focuses on foot preparation. Participants attend individual weekly sessions lasting approximately 30 minutes. Sessions include foot massage, sensory stimulation activities, and gentle foot mobilization exercises. Participants are encouraged to perform selected exercises independently between sessions. Minimalist footwear is introduced at the end of this phase and may be used outside supervised sessions according to participant preference and tolerance. The second phase (sessions 4 to 6) focuses on transition toward active exercise. Participants attend weekly group sessions lasting approximately 45 minutes. Activities emphasize foot and ankle mobility, strengthening of intrinsic and extrinsic foot muscles, and progressive motor control exercises. Brief foot massage is maintained as preparation for exercise. The third phase (sessions 7 to 12) focuses on stabilization and functional integration. Participants continue weekly group sessions and progressively incorporate minimalist footwear into the intervention. Exercises acquired during previous phases are reinforced and integrated into functional activities involving posture, balance, gait, and mobility. The objective is to facilitate transfer of acquired abilities into daily activities and support functional autonomy. Participants allocated to the control group will receive balance workshops only. All participants, regardless of group allocation, will participate in a standardized balance training program. Balance workshops will be conducted once weekly for approximately one hour throughout the study period. Sessions may be delivered by external adapted physical activity providers, adapted physical activity professionals employed by the facility, or physiotherapists, depending on local organization. To ensure consistency across study sites, all instructors will follow a predefined exercise framework and standardized session structure. Sessions will include warm-up exercises, static and dynamic balance training, and functional strengthening activities. Exercise intensity and difficulty may be adapted to individual participant abilities while preserving the core components of the program. Following completion of the initial 12-week intervention period, participants in both groups will continue attending weekly balance workshops for an additional 12 weeks. During this follow-up period, no Foot Health Program sessions will be provided. Outcome assessments will be performed at three time points. Baseline assessments (T0) will be conducted within 15 days before the first intervention session. Post-intervention assessments (T1) will be conducted within 15 days after completion of the first 12 sessions. Follow-up assessments (T2) will be conducted after completion of the additional 12 weeks of balance training. In addition to study outcome measures, data collected at T1 will include attendance rates, adherence to the intervention, participant satisfaction with the workshops, satisfaction with minimalist footwear, and footwear utilization. At T2, satisfaction with footwear and continued footwear use will be reassessed. All study data collected at T0, T1, and T2 will be recorded by trained members of the study team and entered into an electronic case report form (eCRF) by qualified clinical research personnel. The study is designed to determine whether a multimodal intervention targeting foot health provides additional benefits beyond standardized balance training alone in nursing home residents and may contribute to the development of new strategies for maintaining mobility, balance, and functional independence in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture, 12 workshops are planned, every week.
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.
EHPAD " Les 2 Volcans"
Allègre, France
EHPAD "Foyer Notre-Dame"
Beaulieu, France
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.
Time frame: at baseline assessment (T0) and after the 12 intervention sessions (T1)
Changes in the position of the center of pressure during static stance
Changes in the movement of the center of pressure in a static position, measured using a stabilometry platform, with eyes open and closed, at baseline assessment (T0), after the foot care intervention (T1), and at the end of the study (T2). Postural control is generally assessed by analyzing the length of the center of pressure trajectory, which quantifies the extent of body sway and stability while standing. The displacement of the center of pressure is widely recognized as one of the most reliable indicators of postural stability 43. When the eyes are open, postural control relies primarily on the visual system, whereas when the eyes are closed, the vestibular system, proprioceptive inputs, and plantar mechanoreceptors play a more significant role in maintaining balance.
Time frame: 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)
Changes in muscle strength of the big toe flexors (hallux) measured using a dynamometer (The Toe Strength Dynamometer) at baseline assessment (T0) and after the foot care intervention (T1) and the end of the study (T2). In older adults, muscle strength loss has recently emerged as a risk factor for falls. The dynamometer used in this study demonstrated moderate to excellent intra-rater reliability, as well as good to excellent inter-rater reliability for all measurements.
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EHPAD "Bon secours"
Beauzac, France
EHPAD "Vert Bocage"
Brives-Charensac, France
EHPAD "Sainte Monique"
Coubon, France
EHPAD "Saint Dominique"
Craponne-sur-Arzon, France
EHPAD Centre Hospitalier du Pays De Craponne
Craponne-sur-Arzon, France
EHPAD "Le grand pré "
Lantriac, France
EHPAD "Les Terrasses de la Gazeille"
Le Monastier-sur-Gazeille, France
EHPAD "Bel Horizon"
Le Puy-en-Velay, France
...and 10 more locations
Time frame: 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
Changes in ankle joint range of motion in dorsiflexion and plantar flexion, measured using a digital goniometer, at baseline assessment (T0) and after the foot care intervention (T1) and the end of the study (T2). The Weight-Bearing Lunge test is commonly used to assess the range of dorsiflexion of the ankle. However, during our feasibility study, it proved difficult to perform in a population of very elderly individuals. To overcome this difficulty, we will use a digital goniometer.
Time frame: at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).
Changes in participants' fear of falling
Changes in participants' fear of falling, measured using a 0-10 numerical rating scale at baseline assessment (T0) and after the foot care intervention (T1) and the end of the study (T2). The use of a binary question to assess fear of falling is reliable and easy to use in research and clinical practice, particularly in nursing homes.
Time frame: at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).
Changes in foot pain experienced while walking
Changes in foot pain experienced while walking, measured at baseline assessment (T0) and after the foot care intervention (T1) and the end of the study (T2) using a numerical scale from 0 to 10;
Time frame: at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).
The Evolution of Mobility Through the TUG
Changes in mobility as measured by the TUG, assessed after the foot care intervention (T1) and the end of the study (T2).
Time frame: after the 12 intervention sessions (T1) and 6 months (T2).
The incidence of falls measured over the course of the study
The recording of falls during the study period, using fall reports from medical records and a patient questionnaire
Time frame: From baseline assessment (T0) until 6 months (T2)
Participants' satisfaction with minimalist shoes and the various workshops
Participants' satisfaction with minimalist shoes and the various workshops, as measured by a questionnaire administered after the foot care intervention (T1) and the end of the study (T2).
Time frame: after the 12 intervention sessions (T1) and 6 months (T2).
The number of hours per day that shoes were worn by participants in the experimental group
The number of hours per day that shoes were worn by participants in the experimental group following the foot care intervention (T1) and at the end of the study (T2), as reported via a questionnaire.
Time frame: after the 12 intervention sessions (T1) and 6 months (T2).