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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.