Chronic Ankle InstabilityNCT05585385
Effect of Backward Walking Versus Balance Training in Chronic Ankle Instability Patients
A study testing Backward Walking Training, Balance Training and Conventional treatment in people with Chronic Ankle Instability, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to investigate the effect of backward walking versus balance training in patients with chronic ankle instability. The main question it aims to answer is: Is there a difference between the effect of balance training and BW training on balance, ankle proprioception, risk of fall, and… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Backward Walking Training, Balance Training and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2022to 25 Jun 2023
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects will complete a questionnaire by self-report (Cumberland Ankle Instability Tool (CAIT) to be characterized as having Functional Ankle Instability (FAI) ; All subjects' scores on CAIT will be less than 23 to be severely identified with FAI. Subjects will satisfy the following criteria:
- Having FAI that persists after the initial lateral ankle sprain and complaining of residual symptoms (repeated episodes of giving way or feeling of ankle joint instability) and suffering of repeating injury.
- Having mechanical ankle instability on one ankle joint (will be identified by manual testing as talar tilt and anterior drawer test of the ankle to determine the integrity of ankle ligaments).
- Their age ranges from 18 to 35 years.
- Subjects with body mass index less than 30 kg/m2.
- Not undergoing any formal or informal rehabilitation of the unstable ankle.
Who cannot join
- Ankle joint swelling or any rheumatological disorders in both legs.
- Ankle surgery in either leg.
- Gross limitation in ankle range of motion in both legs.
- Any joint disease or bony fracture in the lower extremity.
- History of neurological disorder affecting the upper or lower extremities, vestibular dysfunction, or balance disorder.
- Receiving formal or informal rehabilitation of their unstable ankle for 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to investigate the effect of backward walking versus balance training in patients with chronic ankle instability. The main question it aims to answer is:
Is there a difference between the effect of balance training and BW training on balance, ankle proprioception, risk of fall, and functional limitations in CAI patients?
Read the detailed description
Lateral ankle sprains are among the most common musculoskeletal injuries. Approximately 40% of individuals who have ever suffered any lateral ankle sprain will develop chronic ankle instability which is defined as posterior mechanical and functional deficits in this joint.
Balance is the process that maintains the center of gravity within the body's support base, which needs constant adjustments with joint positioning and muscular activity. Many musculoskeletal and nervous system diseases can alter balance control. It has been reported that individuals with CAI have poor static and dynamic balance compared to those with normal ankles, and this affection of balance, increases the falling risks and leads to serious injuries.
A reversal of normal walking is simply recognized as retro-walking or backward walking (BW), where the toes first reach the ground and finish with the heel off. BW training causes changes in the motion control system and gait characteristics and exerts a positive effect on postural stability.
Sixty patients with chronic ankle instability will be assigned randomly into 3 equal groups; group A will receive BW training in addition to the traditional physical therapy program for 3 sessions/ week, over 6 weeks periods, Group B: will receive balance training on Biodex balance system in addition to the traditional physical therapy program for 3 sessions/ week, over 6 weeks periods, group C: will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks periods.
- Conditions
- Chronic Ankle Instability
- Being tested
- Backward Walking Training, Balance Training, Conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backward Walking TrainingDevice
The subjects in this group will receive BW training program on an electric treadmill. The subject will be asked to walk, arms beside, in a backward manner on a level treadmill, zero inclination, with a warming up and cooling down period (5 minutes for each period). The subject walks at his self-selected and comfortable walking speed. A warm-up and cool-down period, in form of light jogging on a treadmill, will be done at speed of 1-2 m/sec. The total training is 30 minutes, three times a week for six consecutive weeks.
Balance TrainingDevice
Subjects in this group will receive balance training on Biodex Balance System for 3 sessions/ week, over 6 weeks period. Each subject will be instructed to stand with both legs on the "locked" platform. The researcher advances the platform to an unstable state while instructing the subject to focus on the visual feedback screen. Arms are free at the side of the body and not grasping handrails.
After selecting the stability training program (dynamic balance training), Stability levels are changed depending on the subject's ability to maintain balance, and subjects are instructed to maintain their Center of Pressure (COP) in the smallest concentric rings (balance zones) of the Biodex Balance System monitor, named A zone.
The stability level of the platform is set at level plate stability 8 (the most stable) for the first two sessions. After that, the plate stability is decreased by one level every two sessions to increase the difficulty in training.
Conventional treatmentOther
Patients in this group will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks period. The traditional physical therapy program is (evertors strengthening, short foot ex, heel raise ex, and calf stretch).
| Study group | Role | What they receive |
|---|---|---|
| Backward Walking Training | Experimental | The patients will receive BW training in addition to the traditional physical therapy program for 6 weeks. Receives: Device: Backward Walking Training |
| Balance Training | Experimental | The patients will receive balance training on the Biodex balance system in addition to the traditional physical therapy program for 6 weeks. Receives: Device: Balance Training |
| conventional treatment | Active comparator | The patients will receive the traditional physical therapy program only for 6 weeks. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance Assessment
Dynamic balance is assessed by the Biodex stability system which has a high level of accuracy in determining dynamic equilibrium for postural control testing. It establishes three numeric stability indexes: Overall Stability Index (OSI), Anterior/Posterior Stability Index (APSI), and Medial/Lateral Stability Index (MLSI), to assess the body's deviation from its gravity center. The OSI indicates the overall score in all directions, while the APSI and MLSI represent the sagittal and frontal planes, respectively. The higher the stability, the lower the ranking.
Measured: up to 6 weeks
Active repositioning accuracy of ankle joint
Ankle proprioception will be assessed by a digital goniometer. The starting position for ankle joint testing is 90 degree. The maximum ankle planter flexion for each subject will be measured, and half this max. range will be selected as the target position. Subjects will be asked to remain in that position for 10 seconds. The subject with closed eyes actively moves the ankle from starting position (90 degrees) to the targeted plantar-flexion angle with constant speed during the test (they were asked to return to the initial position and progressively move towards the target degree). This process would be repeated 3 times and the average error in active repositioning of the targeted angle would be taken.
Measured: up to 6 weeks
Functional limitations
Functional disability will be assessed by the Foot and Ankle Disability Index (FAID).This index is a 34-item questionnaire divided into subscales, FADI and FADI sport. FADI contains 4 pain related items and 22 activity related items, while the FADI sport contains 8 activity related items. Each question can be scored on a 5- point Likert scale (from 0 to four). FADI and FADI sport are scored separately. FADI has total score of 104 points and FADI Sport 32 points. Both are transformed into percentage.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start2 Nov 2022
- Primary completion1 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies 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
- Backward Walking Training and Balance Training
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ibrahim Ibrahim ElGayar, Cairo University
- Investigators
- Neveen A. Abdel Raoof, PhD, Study chair, Cairo UniversityGhada A. Abd Allah, PhD, Study director, Cairo UniversityRania R. Mohamed, PhD, Study director, Cairo UniversityAmr A. Azzam, PhD, Study director, National Institute of Neuromotor System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585385
- Sponsor's protocol ID
- P.T.REC/012/003911
- Status last verified
- Jul 2023
- First submitted
- 14 Oct 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Backward Walking Versus Balance Training in Chronic Ankle Instability Patients
- ClinicalTrials.gov ID
- NCT05585385
- Acronym / sponsor ID
- P.T.REC/012/003911
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 18 Oct 2022 (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 investigate the effect of backward walking versus balance training in patients with chronic ankle instability. The main question it aims to answer is:
Is there a difference between the effect of balance training and BW training on balance, ankle proprioception, risk of fall, and functional limitations in CAI patients?
Detailed description
Lateral ankle sprains are among the most common musculoskeletal injuries. Approximately 40% of individuals who have ever suffered any lateral ankle sprain will develop chronic ankle instability which is defined as posterior mechanical and functional deficits in this joint.
Balance is the process that maintains the center of gravity within the body's support base, which needs constant adjustments with joint positioning and muscular activity. Many musculoskeletal and nervous system diseases can alter balance control. It has been reported that individuals with CAI have poor static and dynamic balance compared to those with normal ankles, and this affection of balance, increases the falling risks and leads to serious injuries.
A reversal of normal walking is simply recognized as retro-walking or backward walking (BW), where the toes first reach the ground and finish with the heel off. BW training causes changes in the motion control system and gait characteristics and exerts a positive effect on postural stability.
Sixty patients with chronic ankle instability will be assigned randomly into 3 equal groups; group A will receive BW training in addition to the traditional physical therapy program for 3 sessions/ week, over 6 weeks periods, Group B: will receive balance training on Biodex balance system in addition to the traditional physical therapy program for 3 sessions/ week, over 6 weeks periods, group C: will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Backward Walking Training and Balance Training
| Arm | Type | Receives |
|---|---|---|
| Backward Walking Training | Experimental | Device: Backward Walking TrainingThe patients will receive BW training in addition to the traditional physical therapy program for 6 weeks. |
| Balance Training | Experimental | Device: Balance TrainingThe patients will receive balance training on the Biodex balance system in addition to the traditional physical therapy program for 6 weeks. |
| conventional treatment | Active comparator | Other: Conventional treatmentThe patients will receive the traditional physical therapy program only for 6 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All subjects will complete a questionnaire by self-report (Cumberland Ankle Instability Tool (CAIT) to be characterized as having Functional Ankle Instability (FAI) ; All subjects' scores on CAIT will be less than 23 to be severely identified with FAI. Subjects will satisfy the following criteria:
- Having FAI that persists after the initial lateral ankle sprain and complaining of residual symptoms (repeated episodes of giving way or feeling of ankle joint instability) and suffering of repeating injury.
- Having mechanical ankle instability on one ankle joint (will be identified by manual testing as talar tilt and anterior drawer test of the ankle to determine the integrity of ankle ligaments).
- Their age ranges from 18 to 35 years.
- Subjects with body mass index less than 30 kg/m2.
Key exclusion criteria (6 listed)
- Ankle joint swelling or any rheumatological disorders in both legs.
- Ankle surgery in either leg.
- Gross limitation in ankle range of motion in both legs.
- Any joint disease or bony fracture in the lower extremity.
- History of neurological disorder affecting the upper or lower extremities, vestibular dysfunction, or balance disorder.
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 |
|---|---|---|
| Backward Walking TrainingThe subjects in this group will receive BW training program on an electric treadmill. The subject will be asked to walk, arms beside, in a backward manner on a level treadmill, zero inclination, with a warming up and cooling down period (5 minutes for each period). The subject walks at his self-selected and comfortable walking speed. A warm-up and cool-down period, in form of light jogging on a treadmill, will be done at speed of 1-2 m/sec. The total training is 30 minutes, three times a week for six consecutive weeks. | Device | Backward Walking Training |
| Balance TrainingSubjects in this group will receive balance training on Biodex Balance System for 3 sessions/ week, over 6 weeks period. Each subject will be instructed to stand with both legs on the "locked" platform. The researcher advances the platform to an unstable state while instructing the subject to focus on the visual feedback screen. Arms are free at the side of the body and not grasping handrails. After selecting the stability training program (dynamic balance training), Stability levels are changed depending on the subject's ability to maintain balance, and subjects are instructed to maintain their Center of Pressure (COP) in the smallest concentric rings (balance zones) of the Biodex Balance System monitor, named A zone. The stability level of the platform is set at level plate stability 8 (the most stable) for the first two sessions. After that, the plate stability is decreased by one level every two sessions to increase the difficulty in training. | Device | Balance Training |
| Conventional treatmentPatients in this group will receive the traditional physical therapy program only for 3 sessions/ week, over 6 weeks period. The traditional physical therapy program is (evertors strengthening, short foot ex, heel raise ex, and calf stretch). | Other | conventional treatment |
Primary outcome
Dynamic Balance Assessment
Time frame: up to 6 weeks
Dynamic balance is assessed by the Biodex stability system which has a high level of accuracy in determining dynamic equilibrium for postural control testing. It establishes three numeric stability indexes: Overall Stability Index (OSI), Anterior/Posterior Stability Index (APSI), and Medial/Lateral Stability Index (MLSI), to assess the body's deviation from its gravity center. The OSI indicates the overall score in all directions, while the APSI and MLSI represent the sagittal and frontal planes, respectively. The higher the stability, the lower the ranking.
Active repositioning accuracy of ankle joint
Time frame: up to 6 weeks
Ankle proprioception will be assessed by a digital goniometer. The starting position for ankle joint testing is 90 degree. The maximum ankle planter flexion for each subject will be measured, and half this max. range will be selected as the target position. Subjects will be asked to remain in that position for 10 seconds. The subject with closed eyes actively moves the ankle from starting position (90 degrees) to the targeted plantar-flexion angle with constant speed during the test (they were asked to return to the initial position and progressively move towards the target degree). This process would be repeated 3 times and the average error in active repositioning of the targeted angle would be taken.
Functional limitations
Time frame: up to 6 weeks
Functional disability will be assessed by the Foot and Ankle Disability Index (FAID).This index is a 34-item questionnaire divided into subscales, FADI and FADI sport. FADI contains 4 pain related items and 22 activity related items, while the FADI sport contains 8 activity related items. Each question can be scored on a 5- point Likert scale (from 0 to four). FADI and FADI sport are scored separately. FADI has total score of 104 points and FADI Sport 32 points. Both are transformed into percentage.
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 18 Jul 2023.
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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.
Neveen A. Abdel Raoof, PhD study chair
Cairo University
Ghada A. Abd Allah, PhD study director
Cairo University
Rania R. Mohamed, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Backward Walking Training, Balance Training and Conventional treatment in people with Chronic 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 6 inclusion and 6 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 18 Jul 2023. 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?
Dynamic Balance Assessment (time frame: up to 6 weeks). The study lists 3 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 18 Jul 2023.