Ankle SprainsNCT06866808
Combined Effects of Talocrural MWM and Therapeutic US on Pain, Balance and Disability in Athletes With Ankle Sprain
A study testing talocrural MWM and Therapeutic US and Conventional physiotherapy in people with Ankle Sprains, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- talocrural MWM and Therapeutic US and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 30 Sep 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Athletes age 18 to 40 years
- Patients diagnosed with ankle sprain.
- Onset of ankle pain during last six weeks.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Talocrural Mobilization With Movement and Therapeutic Ultrasound on Pain, Balance and Disability in Athletes With Ankle Sprain.
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.
Read the 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.
- Conditions
- Ankle Sprains
- Being tested
- talocrural MWM and Therapeutic US, Conventional physiotherapy
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talocrural MWM and Therapeutic USOther
Mobilization with movement alongwith the therapeutic ultrasound
Conventional physiotherapyOther
Ankle isometrics, calf stretches, icing
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group receive Talocrural mobilization with therapeutic ultrasound therapy. Receives: Other: talocrural MWM and Therapeutic US |
| Control Group | Other | Control Group receive the conventional physiotherapy treatment including icing and ankle isometrics. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Athlete disability index
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)
Measured: 6 weeks
Berg balance scale
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.
Measured: 6 weeks
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a widely used tool for assessing subjective experiences, particularly pain intensity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2024
- Primary completion1 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeela Arif, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866808
- Sponsor's protocol ID
- Aman Naveed
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30040011Kaminski 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.
PubMed 31116041D'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.
PubMed 32377961Chen 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.
PubMed 31385837Sarcon 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.
PubMed 35097325Medina 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.
PubMed 31184957Halabchi 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.
PubMed 33362991Herzog 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.
PubMed 31135209
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Talocrural Mobilization With Movement and Therapeutic Ultrasound on Pain, Balance and Disability in Athletes With Ankle Sprain.
- ClinicalTrials.gov ID
- NCT06866808
- Acronym / sponsor ID
- Aman Naveed
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Mar 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: talocrural MWM and Therapeutic USExperimental group receive Talocrural mobilization with therapeutic ultrasound therapy. |
| Control Group | Other | Other: Conventional physiotherapyControl Group receive the conventional physiotherapy treatment including icing and ankle isometrics. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Athletes age 18 to 40 years
- Patients diagnosed with ankle sprain.
- Onset of ankle pain during last six weeks.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| talocrural MWM and Therapeutic USMobilization with movement alongwith the therapeutic ultrasound | Other | Experimental Group |
| Conventional physiotherapyAnkle isometrics, calf stretches, icing | Other | Control Group |
Primary outcome
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)
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.
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.
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 10 Mar 2025.
- Background: PubMed 30040011Ersoy 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.
- Background: PubMed 31116041Kaminski 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.
- Background: PubMed 32377961D'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.
- Background: PubMed 31385837Chen 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.
- Background: PubMed 35097325Sarcon 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.
- Background: PubMed 31184957Medina 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.
- Background: PubMed 33362991Halabchi 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.
- Background: PubMed 31135209Herzog 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.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
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Enovis High Ankle Sprain Brace Testing
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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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.
Adeela Arif, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing talocrural MWM and Therapeutic US and Conventional physiotherapy in people with Ankle Sprains, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 5 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 10 Mar 2025. 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 Pakistan. 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?
Athlete disability index (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866808, which also lists 8 linked publications.
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 10 Mar 2025.