Clinical trial NCT06348667: Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults
Official title: Randomized, Controlled, Single-Blind, Longitudinal Experimental Study With Follow-up on the Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability and Mobility in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: Ankle stability
Ankle mobility
Balance training
Older Adults
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 75
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to assess the effectiveness of adding specific Blackboard Training (BB) exercises to conventional physiotherapy in improving foot and ankle parameters essential for fall prevention among older adults.

The main questions it aims to answer are:

1. Can the addition of BB exercises improve ankle dorsiflexion mobility?
2. Can the addition of BB exercises enhance single-leg stability and control of mediolateral displacement of the center of pressure?

Participants will be divided into control and intervention groups. Both groups will receive their usual conventional physiotherapy exercises. The intervention group will undergo a 5-week program comprising 10 sessions of BB exercises targeting ankle mobility and balance.

Participants will be asked to:

* Perform 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility.
* Engage in 5 rounds of 40-second balance exercises using the BB.

Researchers will compare the intervention group's outcomes with those of the control group to determine the effectiveness of adding BB exercises in improving foot and ankle parameters related to fall prevention.

Detailed description: Age serves as a predictor of single-leg stability, ankle dorsiflexion range, and plantar flexor strength loss in older adults. Various factors contribute to their heightened risk of falls, such as foot pain, reduced ankle and big toe mobility, increased pressure on specific foot regions during stance, and greater mediolateral displacement of center of pressure.

Exercise interventions have strong support in the field of fall prevention. In turn, foot flexor muscle fatigue has been associated with increased displacement of the center of pressures, so training of this muscles may be useful. While several fall prevention strategies for older adults have shown positive outcomes, some studies face limitations like small sample sizes or insufficient improvement in static balance, possibly due to low exercise intensity and specificity.

The conventional use of instability devices like the BOSU, Wobble board, Airex, or Swiss ball presents challenges in older adult contexts due to their bulkiness and indiscriminate instability. Hence, a specific instability training approach could be interesting to address fall risk factors.

This study proposes a Blackboard Training (BB) exercise intervention for older adults, known for its portability, small size, and adaptability, comparable in effectiveness to traditional devices like the BOSU or Wobble board in activating Peroneus longus muscle, essential for single-leg stability.

Participants will be divided into control and intervention groups, both receiving their usual conventional physiotherapy exercises. The intervention group will undergo a 5-week program comprising 10 sessions. Measurements will be taken pre-study, one week prior, post-study completion, and at a follow-up one month later to assess the duration of observed changes. Each session, lasting 50 minutes, will include a warm-up, BB exercises targeting ankle mobility and balance, and a cool-down. Safety precautions, such as parallel bars for support, will be provided during balance exercises. Specific BB exercises will be: 3 sets of 15 repetitions for assisted ankle dorsiflexion mobility and 5 rounds of 40-second balance exercises.

The analyzed variables will include ankle and big toe range of motion (ROM), the Lunge test, bipedal and monopodal stabilometry, strength of ankle and foot, the Timed-Up-and-Go test and the Single-leg Stance Test.

The hypothesis is that adding specific BB training to conventional physiotherapy for older adults can improve foot and ankle parameters essential for fall prevention, including ankle dorsiflexion and single-leg support. Improvement in ankle dorsiflexion and better control of mediolateral displacement of the center of pressure are expected outcomes.

Eligibility criteria: Inclusion criteria:

* Ability to walk at least 5 meters without the need for technical aids
* Achieving a minimum score of 24 on the Mini-Mental State Examination, ensuring cognitive capacity to understand the study
* Attaining a minimum score of 19 on the Tinetti scale

Exclusion criteria:

* Not having participated in any specific stability or ankle training program in the last 6 months
* Not experiencing any musculoskeletal or neural disorders that could hinder study participation (e.g., diabetic foot, hemiplegia, or amputations)
* Individuals at severe risk of falling and those who are solely able to stand without being able to walk, according to the Tinetti scale

Primary outcomes:
measure: Foot and ankle pain
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
measure: Foot and ankle strength
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
measure: Foot and ankle ROM
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
measure: Ankle dorsiflexion under load
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
measure: Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface)
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
measure: Monopodal stability
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
measure: Functional stability
timeFrame: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Rodrigo Martin-San Agustin
Study officials:
affiliation: University of Valencia
name: Rodrigo Martín-San Agustín, Doctor
role: PRINCIPAL_INVESTIGATOR
References: