BalanceNCT04072965
Cross Education Effect of Balance Program in Patients With Ankle Instability
A study testing balance training in people with Balance and Ankle Instability, run by Cairo University at 1 site in Egypt.
Trial summary
Researchers recommended that NeuroMuscularControl (NMC) training should not begin immediately after an acute Lateral Ankle Sprain(LAS) because of pain and weight-bearing restrictions. So, there is a need for an alternative way by which we can begin NMC retraining sooner. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Balance, Ankle Instability
- What is being tested?
- balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2019to 30 Dec 2019
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At least 1 ankle sprain, with the initial sprain occurring more than 1 year before the study
- A feeling of ''giving way'' (at least 2 episodes in the 6 months before the study).
- At least two ''yes'' answers on questions four to eight on the Modified Ankle Instability Instrument (MAII)
Who cannot join
- - A history of previous surgeries or fractures in either limb of the lower extremities.
- - Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.
- - Balance deficits due to vestibular disorders, such as vertebrabasilar insufficiency and/or visual disorders.
- - Neuropathies and diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Researchers recommended that NeuroMuscularControl (NMC) training should not begin immediately after an acute Lateral Ankle Sprain(LAS) because of pain and weight-bearing restrictions. So, there is a need for an alternative way by which we can begin NMC retraining sooner. By training the non-affected ankle (Cross education), clinicians can begin NMC retraining before the individuals can bear weight on the affected ankle, in the acute stage of healing, or even if there is any other precautions or contraindications to exercise due to the injuries. Athletes with more chronic injuries may be able to perform NMC and functional retraining at higher levels than otherwise would be possible by initiating the training on the non affected ankle. Initiating these activities on the non-affected ankle will result in earlier improvements in postural control and function in the affected ankle.
By this way, the rehabilitation times will be short, athletes can return earlier to sport participation or work, health care costs will decrease. Up to the knowledge of the author, there is a gap in research investigating cross education effect of balance program in patients with ankle instability. So, the current study was conducted to reveal the role of this phenomena in such cases and add this phenomenon on the physical therapy field to manage patients with ankle instability (If Cross Education phenomena is effective, this phenomena will be used in rehabilitation).
Read the detailed description
Thirty five females with Chronic Ankle Instability will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study. They will be randomly assigned into three groups; (A) Cross Education (balance training for the non affected side )(n=10), (B) Traditional training(balance training for the affected side) (n=10), (C) control group (no intervention) (n=15). stability indices measured by the Biodex Balance system , Single Leg Stance Test and scores of Star Excursion Balance Test will be assesssed before and after six weeks of Single Leg Balance training.
- Conditions
- Balance, Ankle Instability
- Being tested
- balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance trainingOther
Thirty five females with CAI will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study. The participants will be randomly assigned into three groups; (A) Cross Education will receive single leg balance training for the non affected side (n=10), (B) Traditional training will receive single leg balance training for the affected side (n=10), (C) control group will receive no intervention (n=15).
| Study group | Role | What they receive |
|---|---|---|
| Cross eduacation of balance | Experimental | 10 females with Chronic Ankle Instability will receive balance training for the non affected side for a six weeks Receives: Other: balance training |
| Traditional training | Experimental | 10 females with Chronic Ankle Instability will receive balance training for the affected side for a six weeks Receives: Other: balance training |
| control | No intervention | balance of 15 females with Chronic Ankle Instability will be assessed before and after six weeks of no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change in the Anterior reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
The maximum distance the patient is able to reach in the Anterior direction during standing on one leg measured by centimeter
Measured: 6 weeks
Assessing change in the Posteromedial reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
The maximum distance the patient is able to reach in the Posteromedial direction during standing on one leg measured by centimeter
Measured: 6 weeks
Assessing change in the Posterolateral reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
The maximum distance the patient is able to reach in the Posterolateral direction during standing on one leg measured by centimeter
Measured: 6 weeks
Assessing change in the Composite reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
The mean of the anterior,Posteromedial and Posterolateral reach distances will be divided by the three times the limb lenght of the each patient
Measured: 6 weeks
Assessing change in the Medio-lateral Stability Index (MLSI) measured by the Biodex Balance system between the initial assessment and after six weeks of single leg balance training
The Medio-lateral Stability Index (MLSI) assess the fluctuations from the horizontal along Medio-Lateral (ML) axis of the Biodex Balance System
Measured: 6 weeks
Assessing change in the Antero-posterior Stability Index (APSI) measured by the Biodex Balance System between the initial assessment and after six weeks of single leg balance training
The Antero-posterior Stability Index (APSI) assess the fluctuations from the horizontal along the Antero-Posterior (AP) axis of the BBS
Measured: 6 weeks
Assessing change in the Overall Stability Index (OASI) measured by the Biodex Balance system between the initial assessment and after six weeks of single leg balance training
The Overall Stability Index (OASI) is a composite of the Antero-posterior Stability Index (APSI) and the Medio-lateral Stability Index (MLSI)
Measured: 6 weeks
Assessing change in the time of Single Leg Stance Test between the initial assessment and after six weeks of single leg balance training
The time during which the patient is able to stand on one leg measured by seconds
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Jun 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group (A) Cross Education group(B) Traditional training group (C) control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Magdy Amen Elsotohy, Cairo University
- Investigators
- Nadia Ma Elsotohy, Dr, Principal investigator, Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072965
- Sponsor's protocol ID
- Cross Education of balance
- Status last verified
- Jul 2020
- First submitted
- 20 Aug 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anguish B, Sandrey MA. Two 4-Week Balance-Training Programs for Chronic Ankle Instability. J Athl Train. 2018 Jul;53(7):662-671. doi: 10.4085/1062-6050-555-16.
PubMed 30192681
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Education Effect of Balance Program in Patients With Ankle Instability
- ClinicalTrials.gov ID
- NCT04072965
- Acronym / sponsor ID
- Cross Education of balance
- Conditions
- Balance, Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 28 Aug 2019 (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.
Researchers recommended that NeuroMuscularControl (NMC) training should not begin immediately after an acute Lateral Ankle Sprain(LAS) because of pain and weight-bearing restrictions. So, there is a need for an alternative way by which we can begin NMC retraining sooner. By training the non-affected ankle (Cross education), clinicians can begin NMC retraining before the individuals can bear weight on the affected ankle, in the acute stage of healing, or even if there is any other precautions or contraindications to exercise due to the injuries. Athletes with more chronic injuries may be able to perform NMC and functional retraining at higher levels than otherwise would be possible by initiating the training on the non affected ankle. Initiating these activities on the non-affected ankle will result in earlier improvements in postural control and function in the affected ankle.
By this way, the rehabilitation times will be short, athletes can return earlier to sport participation or work, health care costs will decrease. Up to the knowledge of the author, there is a gap in research investigating cross education effect of balance program in patients with ankle instability. So, the current study was conducted to reveal the role of this phenomena in such cases and add this phenomenon on the physical therapy field to manage patients with ankle instability (If Cross Education phenomena is effective, this phenomena will be used in rehabilitation).
Detailed description
Thirty five females with Chronic Ankle Instability will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study. They will be randomly assigned into three groups; (A) Cross Education (balance training for the non affected side )(n=10), (B) Traditional training(balance training for the affected side) (n=10), (C) control group (no intervention) (n=15). stability indices measured by the Biodex Balance system , Single Leg Stance Test and scores of Star Excursion Balance Test will be assesssed before and after six weeks of Single Leg Balance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- group (A) Cross Education group(B) Traditional training group (C) control
| Arm | Type | Receives |
|---|---|---|
| Cross eduacation of balance | Experimental | Other: balance training10 females with Chronic Ankle Instability will receive balance training for the non affected side for a six weeks |
| Traditional training | Experimental | Other: balance training10 females with Chronic Ankle Instability will receive balance training for the affected side for a six weeks |
| control | No intervention | –balance of 15 females with Chronic Ankle Instability will be assessed before and after six weeks of no intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least 1 ankle sprain, with the initial sprain occurring more than 1 year before the study
- A feeling of ''giving way'' (at least 2 episodes in the 6 months before the study).
- At least two ''yes'' answers on questions four to eight on the Modified Ankle Instability Instrument (MAII)
Key exclusion criteria (4 listed)
- - A history of previous surgeries or fractures in either limb of the lower extremities.
- - Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.
- - Balance deficits due to vestibular disorders, such as vertebrabasilar insufficiency and/or visual disorders.
- - Neuropathies and diabetes
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 |
|---|---|---|
| balance trainingThirty five females with CAI will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study. The participants will be randomly assigned into three groups; (A) Cross Education will receive single leg balance training for the non affected side (n=10), (B) Traditional training will receive single leg balance training for the affected side (n=10), (C) control group will receive no intervention (n=15). | Other | Cross eduacation of balance, Traditional training |
Primary outcome
Assessing change in the Anterior reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The maximum distance the patient is able to reach in the Anterior direction during standing on one leg measured by centimeter
Assessing change in the Posteromedial reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The maximum distance the patient is able to reach in the Posteromedial direction during standing on one leg measured by centimeter
Assessing change in the Posterolateral reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The maximum distance the patient is able to reach in the Posterolateral direction during standing on one leg measured by centimeter
Assessing change in the Composite reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The mean of the anterior,Posteromedial and Posterolateral reach distances will be divided by the three times the limb lenght of the each patient
Assessing change in the Medio-lateral Stability Index (MLSI) measured by the Biodex Balance system between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The Medio-lateral Stability Index (MLSI) assess the fluctuations from the horizontal along Medio-Lateral (ML) axis of the Biodex Balance System
Assessing change in the Antero-posterior Stability Index (APSI) measured by the Biodex Balance System between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The Antero-posterior Stability Index (APSI) assess the fluctuations from the horizontal along the Antero-Posterior (AP) axis of the BBS
Assessing change in the Overall Stability Index (OASI) measured by the Biodex Balance system between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The Overall Stability Index (OASI) is a composite of the Antero-posterior Stability Index (APSI) and the Medio-lateral Stability Index (MLSI)
Assessing change in the time of Single Leg Stance Test between the initial assessment and after six weeks of single leg balance training
Time frame: 6 weeks
The time during which the patient is able to stand on one leg measured by seconds
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 16 Jul 2020.
- Background: PubMed 30192681Anguish B, Sandrey MA. Two 4-Week Balance-Training Programs for Chronic Ankle Instability. J Athl Train. 2018 Jul;53(7):662-671. doi: 10.4085/1062-6050-555-16.
- Individual participant dataSharing planned: No
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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.
Nadia Ma Elsotohy, Dr principal investigator
Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance training in people with Balance and Ankle Instability, run by Cairo University at 1 site in Egypt.
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 4 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 16 Jul 2020. 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 Egypt. 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?
Assessing change in the Anterior reach distance of Star excursion balance test between the initial assessment and after six weeks of single leg balance training (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072965, which also lists 1 linked publication.
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 16 Jul 2020.