Ankle SprainsNCT06241001
Effect of Eccentric Streching vs IASTM of Gastrocnemius and Soleus Muscles in Athletes With Ankle Sprain
A study testing eccentric streching and IASTM in people with Ankle Sprains, run by Riphah International University at 1 site in Pakistan.
Trial summary
The primary objective within the current study is to compare the acute and chronic effects of eccentric training and IASTM on the dorsiflexion ROM. To reduce the risk of Achilles tendinopathy, stretching and eccentric (lengthening) exercises are postulated to improve ankle dorsiflexion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- eccentric streching and IASTM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jan 2024to May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 and above Both genders Ankle sprain acute and Sub acute
Who cannot join
- Acute fracture to lower extremity Arthritis patients Any other trauma or injury to the lower extremity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Railway General Hospital
Rawalpindi
Abdul Wasay, MS-SPT
About this study
The primary objective within the current study is to compare the acute and chronic effects of eccentric training and IASTM on the dorsiflexion ROM. To reduce the risk of Achilles tendinopathy, stretching and eccentric (lengthening) exercises are postulated to improve ankle dorsiflexion. An eccentric exercise lengthens an active muscle while it is under load. Consequently, eccentric calf muscle exercises can also increase ankle dorsiflexion through an increase in calf muscle strength. For the above mentioned reasons, a combination of stretching exercises and eccentric (lengthening) exercises are suggested as preventive intervention to increase ankle dorsiflexion. The biggest goal of IASTM is to remove scar tissues and facilitate a return to normal function following soft tissue recovery. These Techniques, eccentric stretching and IASTM works towards bringing back the normal range of motion and strength, allowing individuals to regain mobility and return to their usual activities and we will find out the better option from these.
Read the detailed description
Ankle sprain is a traumatic injury that occurs to one or more of lateral ankle ligaments: anterior talofibular ligament, posterior talofibular ligament and calcaneofibular ligament. Ankle sprains are one of the most common musculoskeletal injuries. The ankle is the second most commonly injured body part during sports, with ankle sprains being the most common ankle injury. Instrument-Assisted Soft Tissue Mobilization (IASTM) is a type of soft tissue mobilization that uses rigid devices to increase the examination and treatment of soft tissues. According to recent studies, Instrument-Assisted Soft Tissue Mobilization (IASTM) is a new and highly trained myofascial technique that has gained favor in modern decades for treating soft-tissue ailments. To reduce the risk of Achilles tendinopathy, stretching and eccentric (lengthening) exercises are postulated to improve ankle dorsiflexion. An eccentric exercise lengthens an active muscle while it is under load.
Consequently, eccentric calf muscle exercises can also increase ankle dorsiflexion through an increase in calf muscle strength. For the above mentioned reasons, a combination of stretching exercises and eccentric (lengthening) exercises are suggested as preventive intervention to increase ankle dorsiflexion. Eccentric training is an alternative modality that also shows promise for inducing chronic improvement in ROM. In past years there has been different protocols to treat ankle sprain but this study will contribute to more effective method of treating ankle sprain, improving their recovery and also reducing the risk of re-injury. This study will potentially reduce healthcare costs associated with rehabilitation or the need of additional interventions. This study will have fast and more effective rehabilitation method which can boost the athlete performance, making it the treatment of choice for both athletes and sports teams.
- Conditions
- Ankle Sprains
- Being tested
- eccentric streching, IASTM
- Keywords
- Soleus, Gastrocnemius, eccentric, IASTM
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eccentric strechingOther
The player will lift up one leg from starting position so he stands on his to-be-trained leg. For performing eccentric exercises of the gastrocnemius muscles, the player will lower his heel until he will feel a slight stretch, while keeping his knee extended
IASTMOther
Specially designed tools are used to apply longitudinal pressure along muscle fibers, and treatment usually includes applying to more than the tissues in the isolated location of the pain
| Study group | Role | What they receive |
|---|---|---|
| Eccentric streching | Experimental | Group A will receive eccentric stretching for ankle sprain Receives: Other: eccentric streching |
| IASTM | Active comparator | Group B will only receive IASTM. Receives: Other: IASTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments
Measured: four weeks
NPRS
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Measured: four weeks
Goniometer
A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start22 Jan 2024
- Primary completion15 Mar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Wasay Nafe, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241001
- Sponsor's protocol ID
- RiphahIU Asim
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eccentric Streching vs IASTM of Gastrocnemius and Soleus Muscles in Athletes With Ankle Sprain
- ClinicalTrials.gov ID
- NCT06241001
- Acronym / sponsor ID
- RiphahIU Asim
- Conditions
- Ankle Sprains
- Keywords
- Soleus, Gastrocnemius, eccentric, IASTM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 5 Feb 2024 (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.
The primary objective within the current study is to compare the acute and chronic effects of eccentric training and IASTM on the dorsiflexion ROM. To reduce the risk of Achilles tendinopathy, stretching and eccentric (lengthening) exercises are postulated to improve ankle dorsiflexion. An eccentric exercise lengthens an active muscle while it is under load. Consequently, eccentric calf muscle exercises can also increase ankle dorsiflexion through an increase in calf muscle strength. For the above mentioned reasons, a combination of stretching exercises and eccentric (lengthening) exercises are suggested as preventive intervention to increase ankle dorsiflexion. The biggest goal of IASTM is to remove scar tissues and facilitate a return to normal function following soft tissue recovery. These Techniques, eccentric stretching and IASTM works towards bringing back the normal range of motion and strength, allowing individuals to regain mobility and return to their usual activities and we will find out the better option from these.
Detailed description
Ankle sprain is a traumatic injury that occurs to one or more of lateral ankle ligaments: anterior talofibular ligament, posterior talofibular ligament and calcaneofibular ligament. Ankle sprains are one of the most common musculoskeletal injuries. The ankle is the second most commonly injured body part during sports, with ankle sprains being the most common ankle injury. Instrument-Assisted Soft Tissue Mobilization (IASTM) is a type of soft tissue mobilization that uses rigid devices to increase the examination and treatment of soft tissues. According to recent studies, Instrument-Assisted Soft Tissue Mobilization (IASTM) is a new and highly trained myofascial technique that has gained favor in modern decades for treating soft-tissue ailments. To reduce the risk of Achilles tendinopathy, stretching and eccentric (lengthening) exercises are postulated to improve ankle dorsiflexion. An eccentric exercise lengthens an active muscle while it is under load.
Consequently, eccentric calf muscle exercises can also increase ankle dorsiflexion through an increase in calf muscle strength. For the above mentioned reasons, a combination of stretching exercises and eccentric (lengthening) exercises are suggested as preventive intervention to increase ankle dorsiflexion. Eccentric training is an alternative modality that also shows promise for inducing chronic improvement in ROM. In past years there has been different protocols to treat ankle sprain but this study will contribute to more effective method of treating ankle sprain, improving their recovery and also reducing the risk of re-injury. This study will potentially reduce healthcare costs associated with rehabilitation or the need of additional interventions. This study will have fast and more effective rehabilitation method which can boost the athlete performance, making it the treatment of choice for both athletes and sports teams.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric streching | Experimental | Other: eccentric strechingGroup A will receive eccentric stretching for ankle sprain |
| IASTM | Active comparator | Other: IASTMGroup B will only receive IASTM. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18 and above Both genders Ankle sprain acute and Sub acute
Key exclusion criteria (1 listed)
- Acute fracture to lower extremity Arthritis patients Any other trauma or injury to the lower extremity
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 |
|---|---|---|
| eccentric strechingThe player will lift up one leg from starting position so he stands on his to-be-trained leg. For performing eccentric exercises of the gastrocnemius muscles, the player will lower his heel until he will feel a slight stretch, while keeping his knee extended | Other | Eccentric streching |
| IASTMSpecially designed tools are used to apply longitudinal pressure along muscle fibers, and treatment usually includes applying to more than the tissues in the isolated location of the pain | Other | IASTM |
Primary outcome
Foot and Ankle Ability Measure (FAAM)
Time frame: four weeks
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments
NPRS
Time frame: four weeks
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Goniometer
Time frame: four weeks
A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
Abdul Wasay Nafe, MS-SPT 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 eccentric streching and IASTM 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (FAAM) (time frame: four 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?
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 5 Feb 2024.