Clinical trial NCT06866808: Combined Effects of Talocrural MWM and Therapeutic US on Pain, Balance and Disability in Athletes With Ankle Sprain
Official title: Combined Effects of Talocrural Mobilization With Movement and Therapeutic Ultrasound on Pain, Balance and Disability in Athletes With Ankle Sprain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combined Effects of Talocrural MWM and Therapeutic US on Pain, Balance and Disability in Athletes With Ankle Sprain. Study consist of two groups. One group receives conventional physiotherapy treatment conventional physiotherapy treatment including icing and ankle isometrics. Other receives Talocrural mobilization with therapeutic ultrasound therapy on ankle joint.

Detailed description: Ankle sprain is a prevalent injury marked by harm to the ligaments that provide support to the ankle joint. Ligaments are resilient and pliable fibrous structures that establish a connection between bones, providing joint stability. Ankle sprains commonly arise from excessive rotation or bending of the foot, resulting in the stretching or tearing of ligaments. Talocrural mobilization is a therapy method that utilizes manual techniques to treat the Talocrural joint, which is the joint formed by the tibia, fibula, and talus bone in the ankle. This mobilization approach is designed to enhance joint function, expand range of motion, and alleviate symptoms related to limited movement or musculoskeletal disorders that impact the ankle joint.

Randomized Control Trial will be conducted at the Punjab Stadium over a 10-month period. The sample size, after considering a 10% attrition rate, will consist of 15 participants in each group. Group A, the control group, will receive conventional physiotherapy treatment including icing and ankle isometrics, while Group B will undergo Talocrural mobilization with therapeutic ultrasound therapy and conventional physiotherapy. Participants aged 18 to 40 years diagnosed with ankle sprain and experiencing ankle pain within the last six weeks will be included. Exclusion criteria involve a history of ankle or foot fractures, concurrent lower extremity injuries, neurological disorders affecting lower limb function, and recent ankle or foot surgeries within the last six months. Data collection tools include the Foot and Ankle Disability Index (FADI) for disability, Star Excursion Balance Test (SEBT) for balance, and Numeric Pain Rating Scale (NPRS) for pain intensity. The study will involve pre and post assessments over a 6-week duration, analyzing changes within and between groups using statistical tests such as paired sample t-test, Wilcoxon signed rank test, independent sample t-test, and Mann Whitney U test. The Talocrural mobilization protocol for Group B will comprise five sessions per week, each lasting 40 minutes, including 20 minutes of therapeutic ultrasound and 20 minutes of Talocrural mobilization. The data will be analyzed using SSP for Windows software version 25.

Eligibility criteria: Inclusion Criteria:

* Athletes age 18 to 40 years
* Patients diagnosed with ankle sprain.
* Onset of ankle pain during last six weeks.

Exclusion Criteria:

* Previous history of ankle or foot fractures.
* Concurrent lower extremity injuries affecting pain, balance, and disability assessment
* Any neurological disorders affecting lower limb function.
* Recent ankle or foot surgeries within the last six months.
* Planned surgeries in next 6 months

Primary outcomes:
measure: Athlete disability index
timeFrame: 6 weeks
measure: Berg balance scale
timeFrame: 6 weeks
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Punjab Stadium
state: Punjab
Study officials:
affiliation: Riphah International University
name: Adeela Arif, MS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Medina McKeon JM, Hoch MC. The Ankle-Joint Complex: A Kinesiologic Approach to Lateral Ankle Sprains. J Athl Train. 2019 Jun;54(6):589-602. doi: 10.4085/1062-6050-472-17. Epub 2019 Jun 11.
citation: Halabchi F, Hassabi M. Acute ankle sprain in athletes: Clinical aspects and algorithmic approach. World J Orthop. 2020 Dec 18;11(12):534-558. doi: 10.5312/wjo.v11.i12.534. eCollection 2020 Dec 18.
citation: Herzog MM, Kerr ZY, Marshall SW, Wikstrom EA. Epidemiology of Ankle Sprains and Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):603-610. doi: 10.4085/1062-6050-447-17. Epub 2019 May 28.