Clinical trial NCT04599985: Effect of Balance Training Protocols on Balance, Proprioception, ROM, and Pain in Athlete With Chronic Ankle Instability
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ankle Instability
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel groups randomized comparative Trial.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Static Balance
timeFrame: 4-weeks
measure: Proprioception
timeFrame: 4-weeks
measure: Pain intensity,
timeFrame: 4-weeks
measure: Ankle Range of motion
timeFrame: 4-weeks
measure: Dynamic balance
timeFrame: 4-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Rehabilitation Research Chair
Study officials:
affiliation: Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
name: AMIR IQBAL, MPT-Ortho
role: PRINCIPAL_INVESTIGATOR
References: