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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Saudi Arabia1 site
  • Rehabilitation Research Chair

    Riyadh, 11433

Other trials in Saudi Arabia

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.

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 groups in NCT04599985
Study groupRoleWhat they receive
Star excursion balance training (SEBT)ExperimentalReceived 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 comparatorReceived 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted23 Oct 2020
  2. Study start10 Mar 2019
  3. Primary completion19 Jun 2019
  4. Study completion21 Oct 2019

Resources

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)
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

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; AzTrials last refreshed its copy on 6 Nov 2026.

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