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

June 10, 2024 updated by: Rodrigo Martín-San-Agustin, University of Valencia

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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rodrigo Martin-San Agustin, Doctor
  • Phone Number: +34 963 983 853
  • Email: rodrigo.martin@uv.es

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain
        • Rodrigo Martin-San Agustin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Specific ankle stability exercises
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.
Active Comparator: Control

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre, after 5 weeks of intervention, after 1 month of the end of the study
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.
Pre, after 5 weeks of intervention, after 1 month of the end of the study
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.
Pre, after 5 weeks of intervention, after 1 month of the end of the study
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.
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)
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.
Pre, after 5 weeks of intervention, after 1 month of the end of the study
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.
Pre, after 5 weeks of intervention, after 1 month of the end of the study
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.
Pre, after 5 weeks of intervention, after 1 month of the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodrigo Martín-San Agustín, Doctor, University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3184794

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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