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Ankle SprainsNCT05981560

Effects of Closed Chain Exercise Versus Neuromuscular Training on Chronic Ankle Sprain in Football Players

A study testing Group A - Closed Chain Exercise and Group B - Neuromuscular Training Exercise in people with Ankle Sprains and Chronic Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A current study will be conducted to determine the effects of closed-chain exercise versus neuromuscular training on pain, range of motion, and functional performance in football players with a chronic ankle sprain. This study will be a clinical trial conducted at the Pakistan sports board in the Lahore district. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Ankle Sprains, Chronic Pain
What is being tested?
Group A - Closed Chain Exercise and Group B - Neuromuscular Training Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
22 Dec 2022to 30 Jun 2023
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • Both male and female
  • Age 18-35 (3)
  • Grade 1, 2 Ankle Sprain
  • Recurrent ankle Sprains (3)
  • Ankle Sprain Special Tests (Squeeze Test, Talar Tilt Test)

Who cannot join

  • • Traumatic history or Ankle fracture (6 months)
  • any vestibular or balance disorders (1)
  • athletes who had suffered a sprain in the month prior to the start of the study(3)
  • who were taking anti-inflammatory drugs (3)
  • Poor physical fitness
  • Co-morbidities

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Pakistan Sports Board

    Lahore, Punjab Province, 5400

Other trials in Pakistan

About this study

Official title: Effects of Closed Chain Exercise Versus Neuromuscular Training on Pain, Range of Motion, and Functional Performance in Football Players With Chronic Ankle Sprain

A current study will be conducted to determine the effects of closed-chain exercise versus neuromuscular training on pain, range of motion, and functional performance in football players with a chronic ankle sprain. This study will be a clinical trial conducted at the Pakistan sports board in the Lahore district. The study will be completed within the time duration of Six months. Non-probability convenient sampling technique will be used to collect the data. The sample size of 17 participants in each group will be taken in this study to find the effects of closed-chain exercise versus neuromuscular training on pain, range of motion, and functional performance in football players with a chronic ankle sprain. Athletes will be divided into two groups. Group A will be treated with closed-chain exercises and Group B will be with neuromuscular training. Pain (Numeric pain rating scale NPRS), Proprioceptive (balancing on a single leg with the eyes closed, balancing on a wobble board, Dynamic balance (Star Excursion Balance test and Y Balance Test), Functional Ankle Instability (Greek version of the Identification functional ankle instability questionnaire IdFAI), Cumberland Ankle Instability Tool (CHRONIC ANKLE INSTABILITY) and Ankle Instability Instrument (AII), Foot and Ankle Ability Measure (FAAM)-Sport Subscale, Range of Motion ROM (measure Goniometer) will be used as Data collecting tools. Three sessions of treatment per week for 4 weeks will be given. Data will be analyzed on SPSS version 22. In descriptive statistics Frequency tables, pie charts, and bar charts will be used to show the summary of group measurements measured over time.

Read the detailed description

To determine the effects of closed-chain exercise versus neuromuscular training on pain, range of motion, and functional performance in football players with a chronic ankle sprain.

The study design will be a Randomized Clinical trial. Non-Probability Convenient Sampling will be used.

the sample size of 34 subjects is calculated.

TOOLS:

  1. Pain (Numeric pain rating scale NPRS)
  2. Range of Motion ROM (measure Goniometer)
  3. Proprioceptive (balancing on a single leg with the eyes closed, balancing on a wobble board)
  4. Dynamic balance (Star Excursion Balance test and Y Balance Test)
  5. Functional Ankle Instability (Greek version of the Identification functional ankle instability questionnaire IdFAI)
  6. Ankle Instability Instrument (AII)
  7. Foot and Ankle Ability Measure (FAAM)-Sport Subscale The data will be analyzed using SPSS for Windows software, version 25. Statistical significance will be set at P= 0.05. After assessing the normality of the data by Shapiro wilk test it will be decided whether parametric or non-parametric test will be used within a group or between two groups.
Being tested
Group A - Closed Chain Exercise, Group B - Neuromuscular Training Exercise
Keywords
Ankle Sprain, Chronic Ankle Instability, Exercise programs, Neuromuscular Training, Sports Injuries
Medical subject headings
Ankle Injuries, Chronic Pain, Athletic Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A - Closed Chain ExerciseOther

    17 participants were in experimental group giving them closed chain exercise plan of 5 exercises, 10reps x 3sets each, on alternate 3 days per week for duration of 4-weeks, all values measured before and after 4-weeks

  • Group B - Neuromuscular Training ExerciseOther

    17 participants were in experimental group giving them neuromuscular training plan of 5 exercises, 10reps x 3sets each, on alternate 3 days per week for duration of 4-weeks, all values measured before and after 4-weeks.

Study groups in NCT05981560
Study groupRoleWhat they receive
Closed Chain ExerciseExperimentalclosed chain exercise plan given to the participant of this group
Receives: Other: Group A - Closed Chain Exercise
Neuromuscular Training ExerciseExperimentalNeuromuscular training plan given to the participants of this group
Receives: Other: Group B - Neuromuscular Training Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain (NPRS Scale)

    The Numeric Pain Rating Scale (NPRS) is a widely used tool for measuring and assessing pain intensity. It is a simple and subjective rating scale that allows individuals to quantify and communicate their level of pain on a numerical scale.

    The NPRS typically consists of a horizontal or vertical line with numbers ranging from 0 to 10. The numbers represent a continuum of pain intensity, where 0 represents "no pain" and 10 represents the "worst possible pain." The individual is asked to select the number that best corresponds to their current level of pain, with 0 indicating no pain and 10 indicating the most severe pain imaginable.

    Measured: 4 weeks

  2. Range of Motion (Goniometer)

    A goniometer is a measuring tool commonly used in healthcare and physical therapy to assess and quantify the range of motion (ROM) in joints. It consists of a stationary arm, a movable arm, and a protractor or scale to measure angles.

    To measure range of motion with a goniometer, the stationary arm is aligned with a fixed point on the body, typically an anatomical landmark associated with the joint being assessed. The movable arm is aligned with a second anatomical landmark, which moves as the joint is flexed or extended.

    Measured: 4 weeks

  3. Functional Performance (Special Tests)

    Functional performance refers to an individual's ability to perform everyday tasks and activities effectively and independently. It encompasses the physical, cognitive, and emotional skills required to carry out various activities that are necessary for daily living, work, leisure, and social participation.

    Functional performance is closely tied to an individual's overall functional capacity, which involves the integration of physical abilities, such as strength, endurance, balance, and coordination, with cognitive and emotional factors, including problem-solving, decision-making, attention, and motivation.

    The concept of functional performance extends beyond isolated movements or specific skills and focuses on how individuals function within their unique environments and roles.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start22 Dec 2022
  3. Primary completion30 May 2023
  4. Study completion30 Jun 2023

Resources

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
Participant
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05981560
Sponsor's protocol ID
REC/RCR & AHS/23/0402
Status last verified
Jul 2023
First submitted
6 Jun 2023
Last updated
8 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alahmari KA, Kakaraparthi VN, Reddy RS, Silvian P, Tedla JS, Rengaramanujam K, Ahmad I. Combined Effects of Strengthening and Proprioceptive Training on Stability, Balance, and Proprioception Among Subjects with Chronic Ankle Instability in Different Age Groups: Evaluation of Clinical Outcome Measures. Indian J Orthop. 2020 Jul 15;55(Suppl 1):199-208. doi: 10.1007/s43465-020-00192-6. eCollection 2021 May.

    PubMed 34122771
  • Kachanathu S, Hafez A, Alenazi A, Hassan S, Algarni A, Albarrati AJPM, Rehabilitationsmedizin, Kurortmedizin. Efficacy of Closed and Open Kinematic Chain Exercises on Ankle Sprain Rehabilitation. 2016;26(01):28-31.

  • Allois R, Niglia A, Pernice A, Cuesta-Barriuso R. Fascial therapy, strength exercises and taping in soccer players with recurrent ankle sprains: A randomized controlled trial. J Bodyw Mov Ther. 2021 Jul;27:256-264. doi: 10.1016/j.jbmt.2021.03.022. Epub 2021 Apr 2.

    PubMed 34391242
  • Shiravi Z, Shadmehr A, Moghadam ST, Moghadam BA. Comparison of dynamic postural stability scores between athletes with and without chronic ankle instability during lateral jump landing. Muscles Ligaments Tendons J. 2017 May 10;7(1):119-124. doi: 10.11138/mltj/2017.7.1.119. eCollection 2017 Jan-Mar.

    PubMed 28717619
  • Thompson JY, Byrne C, Williams MA, Keene DJ, Schlussel MM, Lamb SE. Prognostic factors for recovery following acute lateral ankle ligament sprain: a systematic review. BMC Musculoskelet Disord. 2017 Oct 23;18(1):421. doi: 10.1186/s12891-017-1777-9.

    PubMed 29061135
  • Greig M, McNaughton L. Soccer-specific fatigue decreases reactive postural control with implications for ankle sprain injury. Res Sports Med. 2014;22(4):368-79. doi: 10.1080/15438627.2014.944300.

    PubMed 25295475
  • Davenport TE, Kulig K, Fisher BE. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial. BMC Complement Altern Med. 2010 Oct 19;10:59. doi: 10.1186/1472-6882-10-59.

    PubMed 20958995
  • Czajka CM, Tran E, Cai AN, DiPreta JA. Ankle sprains and instability. Med Clin North Am. 2014 Mar;98(2):313-29. doi: 10.1016/j.mcna.2013.11.003. Epub 2014 Jan 10.

    PubMed 24559877
  • Faizullin I, Faizullina E. Effects of balance training on post-sprained ankle joint instability. Int J Risk Saf Med. 2015;27 Suppl 1:S99-S101. doi: 10.3233/JRS-150707.

    PubMed 26639734
  • Kim K, Jeon K. Development of an efficient rehabilitation exercise program for functional recovery in chronic ankle instability. J Phys Ther Sci. 2016 May;28(5):1443-7. doi: 10.1589/jpts.28.1443. Epub 2016 May 31.

    PubMed 27313347
  • McCall A, Carling C, Nedelec M, Davison M, Le Gall F, Berthoin S, Dupont G. Risk factors, testing and preventative strategies for non-contact injuries in professional football: current perceptions and practices of 44 teams from various premier leagues. Br J Sports Med. 2014 Sep;48(18):1352-7. doi: 10.1136/bjsports-2014-093439. Epub 2014 May 16.

    PubMed 24837243
  • Mohammadi Nia Samakosh H, Brito JP, Shojaedin SS, Hadadnezhad M, Oliveira R. What Does Provide Better Effects on Balance, Strength, and Lower Extremity Muscle Function in Professional Male Soccer Players with Chronic Ankle Instability? Hopping or a Balance Plus Strength Intervention? A Randomized Control Study. Healthcare (Basel). 2022 Sep 21;10(10):1822. doi: 10.3390/healthcare10101822.

    PubMed 36292269
  • 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.

    PubMed 31184957
  • Hung YJ. Neuromuscular control and rehabilitation of the unstable ankle. World J Orthop. 2015 Jun 18;6(5):434-8. doi: 10.5312/wjo.v6.i5.434. eCollection 2015 Jun 18.

    PubMed 26085985
  • Owoeye OB, Akinbo SR, Tella BA, Olawale OA. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial. J Sports Sci Med. 2014 May 1;13(2):321-8. eCollection 2014 May.

    PubMed 24790486

Questions about this trial

What is this clinical trial studying?

A study testing Group A - Closed Chain Exercise and Group B - Neuromuscular Training Exercise in people with Ankle Sprains and Chronic Pain, 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 5 inclusion and 6 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 8 Aug 2023. 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?

Pain (NPRS Scale) (time frame: 4 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 NCT05981560, which also lists 21 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 8 Aug 2023.

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