Chronic Ankle SprainNCT05393310
Effects of MET vs Mulligan MWM on Pain, Disability & Balance in Athletes With Ankle Sprain
A study testing post isometric relaxation and MWM group in people with Chronic Ankle Sprain, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men only
- Conditions the study is for
- Chronic Ankle Sprain
- What is being tested?
- post isometric relaxation and MWM group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Oct 2021to Dec 2022
- 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 20 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed cases of chronic ankle sprain (grade I or II) (3-4 months)
- Players have spent at least one year in sports
Who cannot join
- • Players undergone surgery or had an accident.
- Any malignant or chronic disease
- Players with the history of fracture in the same ankle
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Pakistan sports board
Lahore, Punjab Province, 5433
Amna Shahid, t-DPT, 03344512823, amna.shahid@riphah.edu.pk
Faiz Ali Mehdi, MS-SPT
- Recruiting
PSB
Lahore, Punjab Province, 5433
Amna Shahid, t-DPT, 03344512823, amna.shahid@riphah.edu.pk
Faiz Ali Mehdi, MS-SPT
About this study
Official title: Effects of Post Isometric Relaxation Versus Mulligan Mobilization With Movement on Pain, Disability and Dynamic Balance in Athletes With Chronic Ankle Sprain
Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve dynamic balance and to restrain athlete from disability due to chronic ankle sprain.
This study will be a randomized clinical trial,non probability convenience sampling technique will be used to collect the data. The sample size of athletes will be taken in this study to find the effect of post isometric relaxation and mulligan mobilization with movement in athletes.
Read the detailed description
Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve dynamic balance and to restrain athlete from disability due to chronic ankle sprain. As the effect of post isometric relaxation in comparison with Mulligan MWM has never been investigated in Athletes, the aim of this study is to investigate and compare the effect of these two techniques on athletes with chronic ankle sprain presented with pain, dynamic imbalance that leads to disability.
This study will be a randomized clinical trial and will be conducted in Pakistan sports board and Multan sports complex. The study will be completed within the time duration of six months. Non probability convenience sampling technique will be used to collect the data. The sample size of athletes will be taken in this study to find the effect of post isometric relaxation and mulligan mobilization with movement in athletes of PSB and MSC, aged 20-35 years, were allocated to both intervention group. The participants will be divided into two groups i-e, MET group and MWM group. MET group will receive post-isometric relaxation technique for gastrocnemius and soleus muscle. Patient will be in prone lying with the ankle out of the bed. 30% of the available strength will applied by the patient against unyielding resistance towards plantarflexion. The therapist will ensure that foot will not actually move and only a static muscle contraction apply and held for 20 seconds. This will be followed by 2-3 second of relaxation, and then the foot passively stretched to dorsiflexion up to the palpated barrier and/or tolerance to stretch. This will continue until no further gains achieved 2 sets of 5 repetitions a day for 3 days a week for 4 weeks. MWM group will receive inferior tibiofibular, talocrural, or cubometatarsal MWM 2-8 treatment sessions over 4 weeks.
- Conditions
- Chronic Ankle Sprain
- Being tested
- post isometric relaxation, MWM group
- Keywords
- ankle sprain, mulligan MWM, METs
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post isometric relaxationOther
The therapist will apply Post isometric relaxation ensure that foot will not actually move and only a static muscle contraction apply and held for 20 seconds. This will be followed by 2-3 second of relaxation, and then the foot passively stretched to dorsiflexion up to the palpated barrier and/or tolerance to stretch. This will continue until no further gains achieved 2 sets of 5 repetitions a day for 3 days a week for 4 weeks
MWM groupOther
MWM group will receive inferior tibiofibular, talocrural, or cubometatarsal MWM 2-8 treatment sessions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| post-isometric relaxation | Experimental | effects of post-isometric relaxation on pain, disability and dynamic balance in athletes with chronic ankle sprain Receives: Other: post isometric relaxation |
| mulligan mobilization with movement | Experimental | effects of mulligan mobilization with movement on pain, disability and dynamic balance in athletes with chronic ankle sprain Receives: Other: MWM group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
Changes from baseline numeric pain rating scale for pain from 0-10 (0 means no pain and 10 means worst pain)
Measured: 4th week
Dorsiflexion lunge test
Participants are instructed to lunge forward until their knee touches the wall (vertical line). The heel is required to remain in contact with the floor at all times. The foot is moved away from the wall to the point where the knee can only make slight contact with the wall, while the heel remains in contact with the floor. This puts the ankle joint in maximal dorsiflexion. The leg not being tested can rest on the the floor and participants are allowed to hold onto the wall for support. The maximum distance from the wall to the tip of the big toe is recorded. The distance is measured in centimeters (cm) with each centimeter corresponding to approximately 3.6° of ankle dorsiflexion
Measured: 4th week
star excursion balance test
The Star Excursion Balance Test is a dynamic test that requires strength, flexibility, and proprioception.
Measured: 4th week
Foot and Ankle outcome score
ankle disability
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 Oct 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle SprainStudies 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, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amna Shahid, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393310
- Sponsor's protocol ID
- REC/22/0401 Faiz Ali
- Status last verified
- Sep 2022
- First submitted
- 23 May 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.
PubMed 12937557McGovern RP, Martin RL. Managing ankle ligament sprains and tears: current opinion. Open Access J Sports Med. 2016 Mar 2;7:33-42. doi: 10.2147/OAJSM.S72334. eCollection 2016.
PubMed 27042147Mohd Salim NS, Umar MA, Shaharudin S. Effects of the standard physiotherapy programme on pain and isokinetic ankle strength in individuals with grade I ankle sprain. J Taibah Univ Med Sci. 2018 Nov 30;13(6):576-581. doi: 10.1016/j.jtumed.2018.10.007. eCollection 2018 Dec.
PubMed 31435381Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Dynamic balance deficits in individuals with chronic ankle instability compared to ankle sprain copers 1 year after a first-time lateral ankle sprain injury. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1086-95. doi: 10.1007/s00167-015-3744-z. Epub 2015 Aug 8.
PubMed 26254090Golightly YM, Devellis RF, Nelson AE, Hannan MT, Lohmander LS, Renner JB, Jordan JM. Psychometric properties of the foot and ankle outcome score in a community-based study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2014 Mar;66(3):395-403. doi: 10.1002/acr.22162.
PubMed 24023029
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Post Isometric Relaxation Versus Mulligan Mobilization With Movement on Pain, Disability and Dynamic Balance in Athletes With Chronic Ankle Sprain
- ClinicalTrials.gov ID
- NCT05393310
- Acronym / sponsor ID
- REC/22/0401 Faiz Ali
- Conditions
- Chronic Ankle Sprain
- Keywords
- ankle sprain, mulligan MWM, METs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 May 2022 (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.
Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve dynamic balance and to restrain athlete from disability due to chronic ankle sprain.
This study will be a randomized clinical trial,non probability convenience sampling technique will be used to collect the data. The sample size of athletes will be taken in this study to find the effect of post isometric relaxation and mulligan mobilization with movement in athletes.
Detailed description
Ankle Sprains are the most common injury in Athletes and have a high rate of recurrence, pain, dynamic balance and disability is the leading cause of season break in athletes with chronic ankle sprain so as we see post isometric relaxation and Mulligan MWM are the useful techniques used to minimize pain, improve dynamic balance and to restrain athlete from disability due to chronic ankle sprain. As the effect of post isometric relaxation in comparison with Mulligan MWM has never been investigated in Athletes, the aim of this study is to investigate and compare the effect of these two techniques on athletes with chronic ankle sprain presented with pain, dynamic imbalance that leads to disability.
This study will be a randomized clinical trial and will be conducted in Pakistan sports board and Multan sports complex. The study will be completed within the time duration of six months. Non probability convenience sampling technique will be used to collect the data. The sample size of athletes will be taken in this study to find the effect of post isometric relaxation and mulligan mobilization with movement in athletes of PSB and MSC, aged 20-35 years, were allocated to both intervention group. The participants will be divided into two groups i-e, MET group and MWM group. MET group will receive post-isometric relaxation technique for gastrocnemius and soleus muscle. Patient will be in prone lying with the ankle out of the bed. 30% of the available strength will applied by the patient against unyielding resistance towards plantarflexion. The therapist will ensure that foot will not actually move and only a static muscle contraction apply and held for 20 seconds. This will be followed by 2-3 second of relaxation, and then the foot passively stretched to dorsiflexion up to the palpated barrier and/or tolerance to stretch. This will continue until no further gains achieved 2 sets of 5 repetitions a day for 3 days a week for 4 weeks. MWM group will receive inferior tibiofibular, talocrural, or cubometatarsal MWM 2-8 treatment sessions over 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post-isometric relaxation | Experimental | Other: post isometric relaxationeffects of post-isometric relaxation on pain, disability and dynamic balance in athletes with chronic ankle sprain |
| mulligan mobilization with movement | Experimental | Other: MWM groupeffects of mulligan mobilization with movement on pain, disability and dynamic balance in athletes with chronic ankle sprain |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed cases of chronic ankle sprain (grade I or II) (3-4 months)
- Players have spent at least one year in sports
Key exclusion criteria (3 listed)
- • Players undergone surgery or had an accident.
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 |
|---|---|---|
| post isometric relaxationThe therapist will apply Post isometric relaxation ensure that foot will not actually move and only a static muscle contraction apply and held for 20 seconds. This will be followed by 2-3 second of relaxation, and then the foot passively stretched to dorsiflexion up to the palpated barrier and/or tolerance to stretch. This will continue until no further gains achieved 2 sets of 5 repetitions a day for 3 days a week for 4 weeks | Other | post-isometric relaxation |
| MWM groupMWM group will receive inferior tibiofibular, talocrural, or cubometatarsal MWM 2-8 treatment sessions over 4 weeks. | Other | mulligan mobilization with movement |
Primary outcome
Numeric pain rating scale
Time frame: 4th week
Changes from baseline numeric pain rating scale for pain from 0-10 (0 means no pain and 10 means worst pain)
Dorsiflexion lunge test
Time frame: 4th week
Participants are instructed to lunge forward until their knee touches the wall (vertical line). The heel is required to remain in contact with the floor at all times. The foot is moved away from the wall to the point where the knee can only make slight contact with the wall, while the heel remains in contact with the floor. This puts the ankle joint in maximal dorsiflexion. The leg not being tested can rest on the the floor and participants are allowed to hold onto the wall for support. The maximum distance from the wall to the tip of the big toe is recorded. The distance is measured in centimeters (cm) with each centimeter corresponding to approximately 3.6° of ankle dorsiflexion
star excursion balance test
Time frame: 4th week
The Star Excursion Balance Test is a dynamic test that requires strength, flexibility, and proprioception.
Foot and Ankle outcome score
Time frame: 4th week
ankle disability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 12937557Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.
- Background: PubMed 27042147McGovern RP, Martin RL. Managing ankle ligament sprains and tears: current opinion. Open Access J Sports Med. 2016 Mar 2;7:33-42. doi: 10.2147/OAJSM.S72334. eCollection 2016.
- Background: PubMed 31435381Mohd Salim NS, Umar MA, Shaharudin S. Effects of the standard physiotherapy programme on pain and isokinetic ankle strength in individuals with grade I ankle sprain. J Taibah Univ Med Sci. 2018 Nov 30;13(6):576-581. doi: 10.1016/j.jtumed.2018.10.007. eCollection 2018 Dec.
- Background: PubMed 26254090Doherty C, Bleakley C, Hertel J, Caulfield B, Ryan J, Delahunt E. Dynamic balance deficits in individuals with chronic ankle instability compared to ankle sprain copers 1 year after a first-time lateral ankle sprain injury. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1086-95. doi: 10.1007/s00167-015-3744-z. Epub 2015 Aug 8.
- Background: PubMed 24023029Golightly YM, Devellis RF, Nelson AE, Hannan MT, Lohmander LS, Renner JB, Jordan JM. Psychometric properties of the foot and ankle outcome score in a community-based study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2014 Mar;66(3):395-403. doi: 10.1002/acr.22162.
- Individual participant dataSharing planned: No
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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.
Amna Shahid principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post isometric relaxation and MWM group in people with Chronic Ankle Sprain, run by Riphah International University at 2 sites 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 2 inclusion and 3 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Faiz Ali Mehdi, MS-SPT (0333-6023110, faizalimehdi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 4th week). The study lists 4 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 NCT05393310, which also lists 5 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 7 Sep 2022.