- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866808
Combined Effects of Talocrural MWM and Therapeutic US on Pain, Balance and Disability in Athletes With Ankle Sprain
Combined Effects of Talocrural Mobilization With Movement and Therapeutic Ultrasound on Pain, Balance and Disability in Athletes With Ankle Sprain.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Punjab Stadium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Experimental group receive Talocrural mobilization with therapeutic ultrasound therapy.
|
Mobilization with movement alongwith the therapeutic ultrasound
|
|
Other: Control Group
Control Group receive the conventional physiotherapy treatment including icing and ankle isometrics.
|
Ankle isometrics, calf stretches, icing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Athlete disability index
Time Frame: 6 weeks
|
The Athlete Disability Index (ADI) is a self-administered questionnaire specifically designed to assess the level of disability experienced by athletes due to low back pain (LBP)
|
6 weeks
|
|
Berg balance scale
Time Frame: 6 weeks
|
The Berg Balance Scale (BBS) is a popular clinical tool for assessing balance and fall risk in older persons.
Katherine Berg created it to assess balance during various activities.
|
6 weeks
|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks
|
The Numeric Pain Rating Scale (NPRS) is a widely used tool for assessing subjective experiences, particularly pain intensity.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adeela Arif, MS, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- Ersoy U, Kocak UZ, Unuvar E, Unver B. The Acute Effect of Talocrural Joint Mobilization on Dorsiflexor Muscle Strength in Healthy Individuals: A Randomized Controlled Single-Blind Study. J Sport Rehabil. 2019 Aug 1;28(6):601-605. doi: 10.1123/jsr.2018-0124.
- Kaminski TW, Needle AR, Delahunt E. Prevention of Lateral Ankle Sprains. J Athl Train. 2019 Jun;54(6):650-661. doi: 10.4085/1062-6050-487-17. Epub 2019 May 22.
- D'Hooghe P, Cruz F, Alkhelaifi K. Return to Play After a Lateral Ligament Ankle Sprain. Curr Rev Musculoskelet Med. 2020 Jun;13(3):281-288. doi: 10.1007/s12178-020-09631-1.
- Chen ET, Borg-Stein J, McInnis KC. Ankle Sprains: Evaluation, Rehabilitation, and Prevention. Curr Sports Med Rep. 2019 Jun;18(6):217-223. doi: 10.1249/JSR.0000000000000603. Erratum In: Curr Sports Med Rep. 2019 Aug;18(8):310. doi: 10.1249/JSR.0000000000000616.
- Sarcon AK, Heyrani N, Giza E, Kreulen C. Lateral Ankle Sprain and Chronic Ankle Instability. Foot Ankle Orthop. 2019 Jun 13;4(2):2473011419846938. doi: 10.1177/2473011419846938. eCollection 2019 Apr.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aman Naveed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Sprains
-
Riphah International UniversityRecruiting
-
Riphah International UniversityRecruitingAnkle SprainsPakistan
-
MEDRx USA, Inc.CompletedAnkle SprainsUnited States
-
Superior UniversityActive, not recruiting
-
Taipei Medical University WanFang HospitalCompleted
-
Lazaros LazarouCompletedAnkle SprainsGreece
-
Rehabilitation Centre ZivotCompletedAnkle SprainsBosnia and Herzegovina
-
Centre Hospitalier Universitaire de Saint EtienneRecruiting
-
Investigación en Hemofilia y FisioterapiaCompleted
-
University of AlcalaCompleted
Clinical Trials on talocrural MWM and Therapeutic US
-
Hacettepe UniversityCompletedHemiplegia, SpasticTurkey
-
Ahram Canadian UniversityRecruitingThoracic Outlet SyndromeEgypt
-
Cairo UniversityCompletedCarpal Tunnel Syndrome
-
Quiropraxia y EquilibrioRecruitingMyofascial Trigger Point Pain (MTrP)Chile
-
Nationwide Children's HospitalCompletedMuscle TightnessUnited States
-
King Saud UniversityCompletedActive Trapezius Trigger Point PainSaudi Arabia
-
University of CadizCompleted
-
Istanbul Kent UniversityIstanbul University - CerrahpasaNot yet recruitingLateral Elbow Tendinopathy (Tennis Elbow)Turkey (Türkiye)
-
Seno Medical Instruments Inc.Completed
-
Cairo UniversityNot yet recruiting