Chronic Ankle InstabilityNCT04599985
Effect of Balance Training Protocols on Balance, Proprioception, ROM, and Pain in Athlete With Chronic Ankle Instability
A study testing star excursion balance training (SEBT) and Simplified star excursion balance training (SSEBT) in people with Chronic Ankle Instability, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The ankle joint sustains injuries particularly in athletics/sports activities at a high rate, resulting in loss of static \& dynamic balance, neuromuscular control, and diminished lower extremity's function. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men only
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- star excursion balance training (SEBT) and Simplified star excursion balance training (SSEBT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Mar 2019to 21 Oct 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 24 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Self-reported case of unilateral CAI with grade I \& II verified on CT/MRI by orthopedic surgeon;
- Aged between 18-25 years;
- Onset between 2 to 6 months;
- Exhibited enough strength and flexibility of lower extremity, available ankle ROM, and coordination to execute SEBT and SSEBT.
Who cannot join
- Self-reported case of bilateral CAI;
- Grade III ankle sprain;
- No past injuries to the lower extremity including ankle sprain within 2-months prior to the commencement of the study;
- Exhibited any neurological, vestibular, and visual disorder;
- Showed muscle tightness, muscle weakness and joint stiffness of lower extremity;
- History of fracture to the ankle; and
- Showed non-cooperation for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Two Balance Training Protocols on Static and Dynamic Balance, Proprioception, Range of Motion, and Pain in Athletes With Chronic Ankle Instability: A Randomized Comparative Study
The ankle joint sustains injuries particularly in athletics/sports activities at a high rate, resulting in loss of static \& dynamic balance, neuromuscular control, and diminished lower extremity's function. This study aimed to compare the effectiveness of two balance-training protocols on balance, proprioception, range of motion (ROM), and pain in male athletes with chronic ankle instability (CAI). Both the balance training protocols were proven to be equally effective in improving the static \& dynamic balance, proprioception, ROM, and pain in athletes with CAI.
Read the detailed description
Injuries to the lower extremity account for 55-90% of all sports injuries. Of these, the knee, ankle, and foot are generally the three most commonly injured anatomic parts in sports. The incidence of ankle injuries is quite high, constituting 20%-25% of all time-loss injuries in every running or jumping sport, including basketball, football, soccer, field hockey, and volleyball. Out of all ankle sprains injuries in sport, 85% cases comprised of lateral ankle sprain (LAS). Up to 74% sufferers of LAS have been accounted for the incidence of chronic ankle instability (CAI). Balance impairments developed as a by-product over extended duration of undermined treatment for ankle injuries. Previous study reported that the dynamic balance greater affected during performing double-leg stance by the patients with CAI than patient with stable ankle when measured by time-to-stabilization (TTS) in the direction of anterior-posterior post tibial nerve stimulation. Thus, concluded that that the value of longer time-to-stabilization indicate an increased relaxation time and after external-perturbation, relatively a longer time needed to identify to a stable pattern.
The management of CAI include both non-surgical and surgical measures. Non-surgical approach includes use of electrical modalities, the rest, ice, compression and elevation of the limb (RICE) principle of therapy for pain relief, functional rehabilitation for gaining strength of the muscles of foot and ankle complex. Moreover, balance training program have been introduced successfully to achieve the static and dynamic balance in order to regain normalcy specially in athletes. Failure of functional rehabilitation indicates for the surgical intervention such as anatomic repair of the anterior talofibular and calcaneofibular ligaments, anatomic reconstruction with autograft or allograft, ankle arthroscopy when intra-articular conditions associated with chronic ankle instability.In literature, there is lack of focus on the Star Excursion Balance Training (SEBT) as well as Simplified Star Excursion Balance Training (SSEBT) which can be used as a balance training protocol for the improvement of dynamic balance especially in the cases of chronic ankle instability. Since, in addition to the static balance, the dynamic balance plays an important role to assesses the balance and neuromuscular control for lower extremity. As lower extremity balance has been linked to the ankle injuries and deteriorated performance in sports.[27]. Hence, the question arises whether a training program using either star excursion balance training (SEBT) or simplified star excursion balance training (SSEBT), can enhance the static and dynamic balance among athletes having chronic ankle instability? A total of 32-participants (male; aged between 18-25 years) with CAI randomly assigned to two groups to receive their postulated balance training protocols. Star excursion balance test, single-leg stance time, foot position sense, visual analog scale, and goniometer were used to assess the dynamic and static balance, proprioception, pain intensity, and ankle ROM respectively at pre-training (baseline) week 1st and post-training week 1st, 2nd, 3rd, and 4th (follow-up).
Both the SEBT and SSEBT protocol proved to be equally effective in the improvement of static \& dynamic balance, ankle joint position sense and ROM, and reduction in ankle pain among athletes with CAI. However, SSEBT protocol aid more advantage over SEBT protocol in terms of time consumption and level of muscle fatigue as it consumes less time and produces less fatigue-level because of its (SSEBT) less reaching task (3-directions only) compared to SEBT (8-directions only). Therefore, it is advice to the physical therapist to use the SSEBT protocol while dealing with the problem of static \& dynamic balance, joint position sense, ROM, and pain among athletes with CAI.
- Conditions
- Chronic Ankle Instability
- Being tested
- star excursion balance training (SEBT), Simplified star excursion balance training (SSEBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
star excursion balance training (SEBT)Other
The SEBT is aimed to be maintained the single limb stance on one leg while reaching farthest possible with the swing leg. An individual can reach farthest with the swing leg while maintaining the balance on the stance leg
Simplified star excursion balance training (SSEBT)Other
It is one of the training protocols, in a simplified way, with respect to star excursion balance test. It consists a series of reaching tasks for the lower limbs in three-directions i.e., anteromedial, medial and posteromedial.
| Study group | Role | What they receive |
|---|---|---|
| Star excursion balance training (SEBT) | Experimental | Received star excursion balance training (SEBT) program. Performed 3-trials in all 8 directions of the SEBT grid. Receives: Other: star excursion balance training (SEBT) |
| Simplified star excursion balance training (SSEBT) | Active comparator | Received simplified star excursion balance training (SSEBT) program. Performed 3-trials in all 3 directions of SSEBT grid. Receives: Other: Simplified star excursion balance training (SSEBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
Static balance assessed by single-leg stance time test with eyes open and closed. It measures the time (in sec) taken by an individual to uphold their base of support with minimal movement while standing on single leg.
Measured: 4-weeks
Proprioception
Assessed by foot position sense. Foot position sense recorded by placing the ankle joint of non-affected side in some degrees of either dorsiflexion or plantarflexion, and asking athlete to match the position with the affected ankle with eyes closed. Angle of difference in the position of ankles was noted in degrees.
Measured: 4-weeks
Pain intensity,
assessed by Visual Analog Scale (VAS). A 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.
Measured: 4-weeks
Ankle Range of motion
Assessed by hand held half-circle goniometer marked with 0 and 180 degree at either end. It has two arm named as stable arm which is fixed in line with the axis of the non-movable arm and movable arm of goniometer is fixed with the movable arm of the body. It is measured in degree.
Measured: 4-weeks
Dynamic balance
The dynamic balance assessed by Star Excursion Balance Test (SEB test) where an individual was asked to stand barefooted on the affected leg and attempt to reach farthest in all 8-directions one by one with the swing leg and return to the starting position while maintaining the balance on the stance leg. Either falling of swing leg or the deviation of stance-leg from its fixed place while attempting to reach farthest in a particular direction and reaching to its starting position considered as a foul to the test and discarded the reading until correct reach performed.
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start10 Mar 2019
- Primary completion19 Jun 2019
- Study completion21 Oct 2019
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.
- 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
- Two-arm, parallel groups randomized comparative Trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT-Ortho, Principal investigator, Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599985
- Sponsor's protocol ID
- RRC-2019-11
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Balance Training Protocols on Static and Dynamic Balance, Proprioception, Range of Motion, and Pain in Athletes With Chronic Ankle Instability: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT04599985
- Acronym / sponsor ID
- RRC-2019-11
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 23 Oct 2020 (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 ankle joint sustains injuries particularly in athletics/sports activities at a high rate, resulting in loss of static \& dynamic balance, neuromuscular control, and diminished lower extremity's function. This study aimed to compare the effectiveness of two balance-training protocols on balance, proprioception, range of motion (ROM), and pain in male athletes with chronic ankle instability (CAI). Both the balance training protocols were proven to be equally effective in improving the static \& dynamic balance, proprioception, ROM, and pain in athletes with CAI.
Detailed description
Injuries to the lower extremity account for 55-90% of all sports injuries. Of these, the knee, ankle, and foot are generally the three most commonly injured anatomic parts in sports. The incidence of ankle injuries is quite high, constituting 20%-25% of all time-loss injuries in every running or jumping sport, including basketball, football, soccer, field hockey, and volleyball. Out of all ankle sprains injuries in sport, 85% cases comprised of lateral ankle sprain (LAS). Up to 74% sufferers of LAS have been accounted for the incidence of chronic ankle instability (CAI). Balance impairments developed as a by-product over extended duration of undermined treatment for ankle injuries. Previous study reported that the dynamic balance greater affected during performing double-leg stance by the patients with CAI than patient with stable ankle when measured by time-to-stabilization (TTS) in the direction of anterior-posterior post tibial nerve stimulation. Thus, concluded that that the value of longer time-to-stabilization indicate an increased relaxation time and after external-perturbation, relatively a longer time needed to identify to a stable pattern.
The management of CAI include both non-surgical and surgical measures. Non-surgical approach includes use of electrical modalities, the rest, ice, compression and elevation of the limb (RICE) principle of therapy for pain relief, functional rehabilitation for gaining strength of the muscles of foot and ankle complex. Moreover, balance training program have been introduced successfully to achieve the static and dynamic balance in order to regain normalcy specially in athletes. Failure of functional rehabilitation indicates for the surgical intervention such as anatomic repair of the anterior talofibular and calcaneofibular ligaments, anatomic reconstruction with autograft or allograft, ankle arthroscopy when intra-articular conditions associated with chronic ankle instability.In literature, there is lack of focus on the Star Excursion Balance Training (SEBT) as well as Simplified Star Excursion Balance Training (SSEBT) which can be used as a balance training protocol for the improvement of dynamic balance especially in the cases of chronic ankle instability. Since, in addition to the static balance, the dynamic balance plays an important role to assesses the balance and neuromuscular control for lower extremity. As lower extremity balance has been linked to the ankle injuries and deteriorated performance in sports.[27]. Hence, the question arises whether a training program using either star excursion balance training (SEBT) or simplified star excursion balance training (SSEBT), can enhance the static and dynamic balance among athletes having chronic ankle instability? A total of 32-participants (male; aged between 18-25 years) with CAI randomly assigned to two groups to receive their postulated balance training protocols. Star excursion balance test, single-leg stance time, foot position sense, visual analog scale, and goniometer were used to assess the dynamic and static balance, proprioception, pain intensity, and ankle ROM respectively at pre-training (baseline) week 1st and post-training week 1st, 2nd, 3rd, and 4th (follow-up).
Both the SEBT and SSEBT protocol proved to be equally effective in the improvement of static \& dynamic balance, ankle joint position sense and ROM, and reduction in ankle pain among athletes with CAI. However, SSEBT protocol aid more advantage over SEBT protocol in terms of time consumption and level of muscle fatigue as it consumes less time and produces less fatigue-level because of its (SSEBT) less reaching task (3-directions only) compared to SEBT (8-directions only). Therefore, it is advice to the physical therapist to use the SSEBT protocol while dealing with the problem of static \& dynamic balance, joint position sense, ROM, and pain among athletes with CAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel groups randomized comparative Trial.
| Arm | Type | Receives |
|---|---|---|
| Star excursion balance training (SEBT) | Experimental | Other: star excursion balance training (SEBT)Received star excursion balance training (SEBT) program. Performed 3-trials in all 8 directions of the SEBT grid. |
| Simplified star excursion balance training (SSEBT) | Active comparator | Other: Simplified star excursion balance training (SSEBT)Received simplified star excursion balance training (SSEBT) program. Performed 3-trials in all 3 directions of SSEBT grid. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Self-reported case of unilateral CAI with grade I \& II verified on CT/MRI by orthopedic surgeon;
- Aged between 18-25 years;
- Onset between 2 to 6 months;
- Exhibited enough strength and flexibility of lower extremity, available ankle ROM, and coordination to execute SEBT and SSEBT.
Key exclusion criteria (7 listed)
- Self-reported case of bilateral CAI;
- Grade III ankle sprain;
- No past injuries to the lower extremity including ankle sprain within 2-months prior to the commencement of the study;
- Exhibited any neurological, vestibular, and visual disorder;
- Showed muscle tightness, muscle weakness and joint stiffness of lower extremity;
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 |
|---|---|---|
| star excursion balance training (SEBT)The SEBT is aimed to be maintained the single limb stance on one leg while reaching farthest possible with the swing leg. An individual can reach farthest with the swing leg while maintaining the balance on the stance leg | Other | Star excursion balance training (SEBT) |
| Simplified star excursion balance training (SSEBT)It is one of the training protocols, in a simplified way, with respect to star excursion balance test. It consists a series of reaching tasks for the lower limbs in three-directions i.e., anteromedial, medial and posteromedial. | Other | Simplified star excursion balance training (SSEBT) |
Primary outcome
Static Balance
Time frame: 4-weeks
Static balance assessed by single-leg stance time test with eyes open and closed. It measures the time (in sec) taken by an individual to uphold their base of support with minimal movement while standing on single leg.
Proprioception
Time frame: 4-weeks
Assessed by foot position sense. Foot position sense recorded by placing the ankle joint of non-affected side in some degrees of either dorsiflexion or plantarflexion, and asking athlete to match the position with the affected ankle with eyes closed. Angle of difference in the position of ankles was noted in degrees.
Pain intensity,
Time frame: 4-weeks
assessed by Visual Analog Scale (VAS). A 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.
Ankle Range of motion
Time frame: 4-weeks
Assessed by hand held half-circle goniometer marked with 0 and 180 degree at either end. It has two arm named as stable arm which is fixed in line with the axis of the non-movable arm and movable arm of goniometer is fixed with the movable arm of the body. It is measured in degree.
Dynamic balance
Time frame: 4-weeks
The dynamic balance assessed by Star Excursion Balance Test (SEB test) where an individual was asked to stand barefooted on the affected leg and attempt to reach farthest in all 8-directions one by one with the swing leg and return to the starting position while maintaining the balance on the stance leg. Either falling of swing leg or the deviation of stance-leg from its fixed place while attempting to reach farthest in a particular direction and reaching to its starting position considered as a foul to the test and discarded the reading until correct reach performed.
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 23 Oct 2020.
- Individual participant dataSharing planned: No
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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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.
AMIR IQBAL, MPT-Ortho principal investigator
Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing star excursion balance training (SEBT) and Simplified star excursion balance training (SSEBT) in people with Chronic Ankle Instability, run by King Saud University at 1 site in Saudi Arabia.
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 4 inclusion and 7 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 23 Oct 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 Saudi Arabia. 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?
Static Balance (time frame: 4-weeks). The study lists 5 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 23 Oct 2020.