Chronic Ankle InstabilityNCT06149052
Effects of SMART VS FIRE Training in Chronic Ankle Instability
A study testing SMART TRAINING and FIRE training in people with Chronic Ankle Instability, run by Sehat Medical Complex at 1 site in Pakistan.
Trial summary
The study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects were enrolled according to eligibility criteria. Patients were divided into two groups, each with 13 patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- SMART TRAINING and FIRE training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Aug 2023to 15 Apr 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Athletes 18-45 years of age,
- 2 repeated episodes of giving way, feelings of instability
- Core training not less than 4 week.
- Chronic ankle instability more than 6 months.
- Repeated ankle sprain more than twice and patients with <24 points based on CAIT.
- Athletes with single side ankle instability
Who cannot join
- Acute concomitant injuries of the ankle.
- Individuals who were able to return to pre-injury levels of activity
- Serious lower-extremity injuries of the last 6 months
- Lower-extremity surgery, and neurological diseases
- Simultaneous severe sprain of both ankle joints
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of SMART Training Intervention Versus Foot Intensive Rehabilitation (FIRE) on Strength and Performance in Athletes With Chronic Ankle Instability
The study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects were enrolled according to eligibility criteria. Patients were divided into two groups, each with 13 patients. Group A received SMART training intervention and warm-up exercises, while group B received Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session was around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime was given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) was done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.
Read the detailed description
Ankle sprain is one of the most common sports injuries in physically active individuals and causes a high financial burden on the healthcare system. Seventy-four percent of patients with an acute ankle sprain suffered from residual symptoms lasting 29 months after the initial ankle sprain, such as pain, perceived instability, weakness and swelling. Lateral ankle sprains (LASs) are a common injury sustained by individuals who participate in recreational physical activities and sports. After LAS, a large proportion of individuals develop long-term symptoms, which contribute to the development of chronic ankle instability (CAI).The aim of this study to determine the comparative effects of SMART training intervention versus foot intensive rehabilitation (FIRE) on strength and performance in athletes with chronic ankle instability.
The study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects was enrolled according to eligibility criteria. Patients was divided into two groups, each with 13 patients. Group A received SMART training intervention and warm-up exercises, while group B received Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session was around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime was given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) was done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.
- Conditions
- Chronic Ankle Instability
- Being tested
- SMART TRAINING, FIRE training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART TRAININGOther
Patients in Group A received SMART training intervention. For sensory stimulation planter massage was given, and it was applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization was given (26). For balance, single and double leg stance was performed. For functional training, lateral hops and SEBT was performed. And at the end, for resistance training, theraband was used with normal ankle joint movement. There is a progress in focus between the five domains over the 3weeks, as described below: The domains S and M are present across the whole intervention. In week 1, the main focus is on the A domain, in week 2 on the R domain, and in week 3 on the T domain. During the 3-week intervention period, 3 training sessions was held per week each lasting approximately 45 - 60 min, including 10 min warm up
FIRE trainingOther
Patients in Group B was received foot intensive rehabilitation (FIRE).The FIRE intervention was include the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage consisted of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises were targeted the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension
| Study group | Role | What they receive |
|---|---|---|
| Group A: warm up exercises with SMART training | Active comparator | For sensory stimulation planter massage was given, and it was applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization was given. For balance, single and double leg stance was performed. For functional training, lateral hops and SEBT was performed. And at the end, for resistance training, theraband was used with normal ankle joint movement. There is a progress in focus between the five domains over the 3weeks, as described below: The domains S and M are present across the whole intervention. In week 1, the main focus is on the A domain, in week 2 on the R domain, and in week 3 on the T domain. During the 3-week intervention period, 3 training sessions was held per week each lasting approximately 45 - 60 min, including 10 min warm up. Receives: Other: SMART TRAINING |
| Group B: Warm up exercises with foot intensive rehabilitation(FIRE) | Active comparator | The FIRE intervention was included the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage consisted of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises were target the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension. Receives: Other: FIRE training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumberland Ankle Instability Tool (CAIT)
Cumberland Ankle Instability Tool (CAIT) was originally developed in English and proved to be of high content validity and good reliability. The main advantage of the questionnaire is that it consists of only 9 items, minimizing patient burden and increasing reliability. The precision of the instrument is increased as it is a multiple answer option instrument
Measured: Change from Baseline at 3 weeks and 6 weeks
Foot and Ankle Ability Measurement (FAAM)
The Foot and Ankle Ability Measure (FAAM) assess the functional limitation of the foot and ankle. The FAAM has 29 items, scored between 0 and 4, divided into two sub-scales: activities of daily living (21 items) and sports (8 items)(24).For score analysis, the percentage of each sub scale is used separately. For FAAM ADL, person reliability is 0.87 and item reliability is0.99. For FAAM Sport, person reliability is 0.89 and item reliability is 1.0
Measured: Change from Baseline at 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start23 Aug 2023
- Primary completion31 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wajeeha konain, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149052
- Sponsor's protocol ID
- REC/RCRS/1021 Wajeeha
- Status last verified
- Apr 2024
- First submitted
- 18 Aug 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin CI, Houtenbos S, Lu YH, Mayer F, Wippert PM. The epidemiology of chronic ankle instability with perceived ankle instability- a systematic review. J Foot Ankle Res. 2021 May 28;14(1):41. doi: 10.1186/s13047-021-00480-w.
PubMed 34049565Herzog 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 31135209Al-Mohrej OA, Al-Kenani NS. Chronic ankle instability: Current perspectives. Avicenna J Med. 2016 Oct-Dec;6(4):103-108. doi: 10.4103/2231-0770.191446.
PubMed 27843798Abadi FH, Sankaravel M, Zainuddin FF, Elumalai G, Razli AI. The effect of aquatic exercise program on low-back pain disability in obese women. J Exerc Rehabil. 2019 Dec 31;15(6):855-860. doi: 10.12965/jer.1938688.344. eCollection 2019 Dec.
PubMed 31938709Delahunt E, Remus A. Risk Factors for Lateral Ankle Sprains and Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):611-616. doi: 10.4085/1062-6050-44-18. Epub 2019 Jun 4.
PubMed 31161942Hall EA, Chomistek AK, Kingma JJ, Docherty CL. Balance- and Strength-Training Protocols to Improve Chronic Ankle Instability Deficits, Part II: Assessing Patient-Reported Outcome Measures. J Athl Train. 2018 Jun;53(6):578-583. doi: 10.4085/1062-6050-387-16. Epub 2018 Jul 11.
PubMed 29995462Jaber H, Lohman E, Daher N, Bains G, Nagaraj A, Mayekar P, Shanbhag M, Alameri M. Neuromuscular control of ankle and hip during performance of the star excursion balance test in subjects with and without chronic ankle instability. PLoS One. 2018 Aug 13;13(8):e0201479. doi: 10.1371/journal.pone.0201479. eCollection 2018.
PubMed 30102713Kim J, Kang S, Kim SJ. A smart insole system capable of identifying proper heel raise posture for chronic ankle instability rehabilitation. Sci Rep. 2022 Jun 24;12(1):10796. doi: 10.1038/s41598-022-14313-8.
PubMed 35750787Molla-Casanova S, Ingles M, Serra-Ano P. Effects of balance training on functionality, ankle instability, and dynamic balance outcomes in people with chronic ankle instability: Systematic review and meta-analysis. Clin Rehabil. 2021 Dec;35(12):1694-1709. doi: 10.1177/02692155211022009. Epub 2021 May 31.
PubMed 34058832
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SMART Training Intervention Versus Foot Intensive Rehabilitation (FIRE) on Strength and Performance in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06149052
- Acronym / sponsor ID
- REC/RCRS/1021 Wajeeha
- Conditions
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 28 Nov 2023 (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 study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects were enrolled according to eligibility criteria. Patients were divided into two groups, each with 13 patients. Group A received SMART training intervention and warm-up exercises, while group B received Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session was around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime was given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) was done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.
Detailed description
Ankle sprain is one of the most common sports injuries in physically active individuals and causes a high financial burden on the healthcare system. Seventy-four percent of patients with an acute ankle sprain suffered from residual symptoms lasting 29 months after the initial ankle sprain, such as pain, perceived instability, weakness and swelling. Lateral ankle sprains (LASs) are a common injury sustained by individuals who participate in recreational physical activities and sports. After LAS, a large proportion of individuals develop long-term symptoms, which contribute to the development of chronic ankle instability (CAI).The aim of this study to determine the comparative effects of SMART training intervention versus foot intensive rehabilitation (FIRE) on strength and performance in athletes with chronic ankle instability.
The study was a randomized clinical trial with the sample size of 26. The study was conducted at Sports Club Sheikhupura. Subjects was enrolled according to eligibility criteria. Patients was divided into two groups, each with 13 patients. Group A received SMART training intervention and warm-up exercises, while group B received Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session was around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime was given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) was done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: warm up exercises with SMART training | Active comparator | Other: SMART TRAININGFor sensory stimulation planter massage was given, and it was applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization was given. For balance, single and double leg stance was performed. For functional training, lateral hops and SEBT was performed. And at the end, for resistance training, theraband was used with normal ankle joint movement. There is a progress in focus between the five domains over the 3weeks, as described below: The domains S and M are present across the whole intervention. In week 1, the main focus is on the A domain, in week 2 on the R domain, and in week 3 on the T domain. During the 3-week intervention period, 3 training sessions was held per week each lasting approximately 45 - 60 min, including 10 min warm up. |
| Group B: Warm up exercises with foot intensive rehabilitation(FIRE) | Active comparator | Other: FIRE trainingThe FIRE intervention was included the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage consisted of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises were target the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Athletes 18-45 years of age,
- 2 repeated episodes of giving way, feelings of instability
- Core training not less than 4 week.
- Chronic ankle instability more than 6 months.
- Repeated ankle sprain more than twice and patients with <24 points based on CAIT.
Key exclusion criteria (5 listed)
- Acute concomitant injuries of the ankle.
- Individuals who were able to return to pre-injury levels of activity
- Serious lower-extremity injuries of the last 6 months
- Lower-extremity surgery, and neurological diseases
- Simultaneous severe sprain of both ankle joints
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 |
|---|---|---|
| SMART TRAININGPatients in Group A received SMART training intervention. For sensory stimulation planter massage was given, and it was applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization was given (26). For balance, single and double leg stance was performed. For functional training, lateral hops and SEBT was performed. And at the end, for resistance training, theraband was used with normal ankle joint movement. There is a progress in focus between the five domains over the 3weeks, as described below: The domains S and M are present across the whole intervention. In week 1, the main focus is on the A domain, in week 2 on the R domain, and in week 3 on the T domain. During the 3-week intervention period, 3 training sessions was held per week each lasting approximately 45 - 60 min, including 10 min warm up | Other | Group A: warm up exercises with SMART training |
| FIRE trainingPatients in Group B was received foot intensive rehabilitation (FIRE).The FIRE intervention was include the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage consisted of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises were targeted the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension | Other | Group B: Warm up exercises with foot intensive rehabilitation(FIRE) |
Primary outcome
Cumberland Ankle Instability Tool (CAIT)
Time frame: Change from Baseline at 3 weeks and 6 weeks
Cumberland Ankle Instability Tool (CAIT) was originally developed in English and proved to be of high content validity and good reliability. The main advantage of the questionnaire is that it consists of only 9 items, minimizing patient burden and increasing reliability. The precision of the instrument is increased as it is a multiple answer option instrument
Foot and Ankle Ability Measurement (FAAM)
Time frame: Change from Baseline at 3 weeks and 6 weeks
The Foot and Ankle Ability Measure (FAAM) assess the functional limitation of the foot and ankle. The FAAM has 29 items, scored between 0 and 4, divided into two sub-scales: activities of daily living (21 items) and sports (8 items)(24).For score analysis, the percentage of each sub scale is used separately. For FAAM ADL, person reliability is 0.87 and item reliability is0.99. For FAAM Sport, person reliability is 0.89 and item reliability is 1.0
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 2 May 2024.
- Background: PubMed 34049565Lin CI, Houtenbos S, Lu YH, Mayer F, Wippert PM. The epidemiology of chronic ankle instability with perceived ankle instability- a systematic review. J Foot Ankle Res. 2021 May 28;14(1):41. doi: 10.1186/s13047-021-00480-w.
- 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.
- Background: PubMed 27843798Al-Mohrej OA, Al-Kenani NS. Chronic ankle instability: Current perspectives. Avicenna J Med. 2016 Oct-Dec;6(4):103-108. doi: 10.4103/2231-0770.191446.
- Background: PubMed 31938709Abadi FH, Sankaravel M, Zainuddin FF, Elumalai G, Razli AI. The effect of aquatic exercise program on low-back pain disability in obese women. J Exerc Rehabil. 2019 Dec 31;15(6):855-860. doi: 10.12965/jer.1938688.344. eCollection 2019 Dec.
- Background: PubMed 31161942Delahunt E, Remus A. Risk Factors for Lateral Ankle Sprains and Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):611-616. doi: 10.4085/1062-6050-44-18. Epub 2019 Jun 4.
- Background: PubMed 29995462Hall EA, Chomistek AK, Kingma JJ, Docherty CL. Balance- and Strength-Training Protocols to Improve Chronic Ankle Instability Deficits, Part II: Assessing Patient-Reported Outcome Measures. J Athl Train. 2018 Jun;53(6):578-583. doi: 10.4085/1062-6050-387-16. Epub 2018 Jul 11.
- Background: PubMed 30102713Jaber H, Lohman E, Daher N, Bains G, Nagaraj A, Mayekar P, Shanbhag M, Alameri M. Neuromuscular control of ankle and hip during performance of the star excursion balance test in subjects with and without chronic ankle instability. PLoS One. 2018 Aug 13;13(8):e0201479. doi: 10.1371/journal.pone.0201479. eCollection 2018.
- Background: PubMed 35750787Kim J, Kang S, Kim SJ. A smart insole system capable of identifying proper heel raise posture for chronic ankle instability rehabilitation. Sci Rep. 2022 Jun 24;12(1):10796. doi: 10.1038/s41598-022-14313-8.
- Background: PubMed 34058832Molla-Casanova S, Ingles M, Serra-Ano P. Effects of balance training on functionality, ankle instability, and dynamic balance outcomes in people with chronic ankle instability: Systematic review and meta-analysis. Clin Rehabil. 2021 Dec;35(12):1694-1709. doi: 10.1177/02692155211022009. Epub 2021 May 31.
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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.
wajeeha konain, MSPT 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 SMART TRAINING and FIRE training in people with Chronic Ankle Instability, run by Sehat Medical Complex 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 6 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 2 May 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?
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?
Cumberland Ankle Instability Tool (CAIT) (time frame: Change from Baseline at 3 weeks and 6 weeks). The study lists 2 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 NCT06149052, which also lists 9 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 2 May 2024.