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Completed

NCT Number: NCT06348667

Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults

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.

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Key information

Conditions

Fall

Age range

75 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rodrigo Martin-San Agustin

Valencia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific ankle stability exercises

Other

Exercise program specifically designed to address ankle dorsiflexion and mediolateral displacement of the center of pressure, using the described device (BB). Done twice a week for 5 weeks.

Conventional physiotherapy exercises program

Other

Conventional exercise program performed in the center twice a week, of which all participants are part.

Primary outcomes

  1. Foot and ankle pain

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    Foot-Function Index (FFI) scale. The FFI consists of 23 items divided into 3 subscales that quantify the impact of foot pathology on pain, disability, and activity limitation. It offers a score from 0 to 267, with higher scores indicating worse outcomes. The total score obtained on the scale is divided by 207 and multiplied by 100 to obtain a final percentage.

  2. Foot and ankle strength

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    Suiff Pro dynamometer. Movements: dorsal and plantar flexion, inversion, eversion of the ankle. Flexion and extension of the big toe.

  3. Foot and ankle ROM

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    Video recording + Kinovea. Movements: dorsal and plantar flexion, inversion, eversion of the ankle. Flexion and extension of the big toe.

  4. Ankle dorsiflexion under load

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    Weight bearing Lunge test. This test is used to assess ankle dorsiflexion. The movement will be recorded for later processing with Kinovea to determine the angle.

  5. Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface)

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    K-Force plates will be used during bipedal and monopodal stances. First on a firm surface with eyes open, and then with eyes closed. The same procedure will be performed on a soft surface.

  6. Monopodal stability

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    Single-leg Stance Test. During this test, the time that the participant is able to maintain single-leg stance without arm support and with eyes open is recorded.

  7. Functional stability

    Time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study

    Timed Up and Go test. In this test, the participant is seated in a chair with a cone placed 3 meters in front of them. Upon signal, they stand up, walk to the cone, walk around it, come back, and sit down again. The time taken to complete the task will be recorded.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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