FallNCT06348667
Effects of a Short- and Long-term 'Blackboard' Intervention on Ankle Stability in Older Adults
A study testing Specific ankle stability exercises and Conventional physiotherapy exercises program in people with Fall, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Specific ankle stability exercises and Conventional physiotherapy exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2024to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- Can the addition of BB exercises improve ankle dorsiflexion mobility?
- 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.
Read the 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.
- Conditions
- Fall
- Being tested
- Specific ankle stability exercises, Conventional physiotherapy exercises program
- Keywords
- Ankle stability, Ankle mobility, Balance training, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific ankle stability exercisesOther
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 programOther
Conventional exercise program performed in the center twice a week, of which all participants are part.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 16 subjects who will perform BB exercises twice a week for 5 weeks under the supervision of a physiotherapist.
Each session (50') will include a warm-up of 10' of slow walking, joint mobility, and stretching. Then, BB exercises will be performed, followed by 10' of relaxation and stretching to cool down.
BB exercises:
* Ankle mobility: single-leg ankle dorsiflexion movements in a standing position on the BB with slight assistance from the parallel bars to perform the movement correctly. The BB will be set with the forefoot fixed and the rearfoot with medial drop, to facilitate dorsiflexion by combining dorsal flexion and pronation. 3 sets of 15 repetitions, with a 1' rest between sets.
* Balance: BB will be set with instability in the forefoot and fixed rearfoot, to produce mediolateral instability of the CoP. The exercise will be maintaining balance on the BB while attempting to keep the lateral edges of the board from touching the ground. Five rounds of 40" work and 1' rest. Receives: Other: Specific ankle stability exercises |
| Control | Active comparator | 16 participants who will perform their conventional exercises protocol. The group exercise sessions (45') take place twice a week. Participants sit in a circle in the room, with the physiotherapist in the center to provide instructions, and perform:
* Warm-up: 5' of joint mobility exercises. Shoulder rotations, elbow flexion and extension, knee flexion and extension, ankle rotations, and standing up and sitting down 5 times.
* Main part: 25-30' (with music). Energetic arm movements, e.g. raising and lowering, front and back, inward and outward arm circles, and lateral shoulder raises like "little birds"... These exercises are performed fast within a controlled ROM. CORE work is done while seated on the edge of the chair, bringing knees to the shoulders and moving the legs up and down. Finally, they stand up and sit down several times, and try to maintain an isometric squat position.
* Cool down: 5-7' of stretching, mainly consisting of active neck mobility and arm stretching. Receives: Other: Conventional physiotherapy exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and ankle pain
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.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Foot and ankle strength
Suiff Pro dynamometer. Movements: dorsal and plantar flexion, inversion, eversion of the ankle. Flexion and extension of the big toe.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Foot and ankle ROM
Video recording + Kinovea. Movements: dorsal and plantar flexion, inversion, eversion of the ankle. Flexion and extension of the big toe.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Ankle dorsiflexion under load
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.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Center of pressures variations (anteroposterior and mediolateral center of pressure displacement, velocity, and total surface)
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.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Monopodal stability
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.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Functional stability
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.
Measured: Pre, after 5 weeks of intervention, after 1 month of the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start7 Mar 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
- Investigators
- Rodrigo Martín-San Agustín, Doctor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348667
- Sponsor's protocol ID
- 3184794
- Status last verified
- Jun 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06348667
- Acronym / sponsor ID
- 3184794
- Conditions
- Fall
- Keywords
- Ankle stability, Ankle mobility, Balance training, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the addition of BB exercises improve ankle dorsiflexion mobility?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Specific ankle stability exercises16 subjects who will perform BB exercises twice a week for 5 weeks under the supervision of a physiotherapist. Each session (50') will include a warm-up of 10' of slow walking, joint mobility, and stretching. Then, BB exercises will be performed, followed by 10' of relaxation and stretching to cool down. BB exercises: * Ankle mobility: single-leg ankle dorsiflexion movements in a standing position on the BB with slight assistance from the parallel bars to perform the movement correctly. The BB will be set with the forefoot fixed and the rearfoot with medial drop, to facilitate dorsiflexion by combining dorsal flexion and pronation. 3 sets of 15 repetitions, with a 1' rest between sets. * Balance: BB will be set with instability in the forefoot and fixed rearfoot, to produce mediolateral instability of the CoP. The exercise will be maintaining balance on the BB while attempting to keep the lateral edges of the board from touching the ground. Five rounds of 40" work and 1' rest. |
| Control | Active comparator | Other: Conventional physiotherapy exercises program16 participants who will perform their conventional exercises protocol. The group exercise sessions (45') take place twice a week. Participants sit in a circle in the room, with the physiotherapist in the center to provide instructions, and perform: * Warm-up: 5' of joint mobility exercises. Shoulder rotations, elbow flexion and extension, knee flexion and extension, ankle rotations, and standing up and sitting down 5 times. * Main part: 25-30' (with music). Energetic arm movements, e.g. raising and lowering, front and back, inward and outward arm circles, and lateral shoulder raises like "little birds"... These exercises are performed fast within a controlled ROM. CORE work is done while seated on the edge of the chair, bringing knees to the shoulders and moving the legs up and down. Finally, they stand up and sit down several times, and try to maintain an isometric squat position. * Cool down: 5-7' of stretching, mainly consisting of active neck mobility and arm stretching. |
Who may qualify
- Ages
- 75 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific ankle stability exercisesExercise 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. | Other | Experimental |
| Conventional physiotherapy exercises programConventional exercise program performed in the center twice a week, of which all participants are part. | Other | Control |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Martín-San Agustín, Doctor principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific ankle stability exercises and Conventional physiotherapy exercises program in people with Fall, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and ankle pain (time frame: Pre, after 5 weeks of intervention, after 1 month of the end of the study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.