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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Emile Roux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Weekly foot health workshops

    Other intervention

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

  • Balance Workshops

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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).
2

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.

Time frame
at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).
3

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).
4

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: