NCT06552533

Brief Summary

Chronic ankle instability is characterized by a patient's being more than 12 months removed from the initial LAS and exhibiting a propensity for recurrent ankle sprains, frequent episodes or perceptions of the ankle giving way, and persistent symptoms such as pain, swelling, limited motion, weakness, and diminished self-reported function. This study will Compare Resistance Training with and without Plyometric exercises on Athletes with Chronic Ankle instability and changes will be recorded using different methods and tools. Patients will be randomly allocated into two different groups. Group A will be treated with resistance training and Group B will be treated with resistance training along with plyometric exercises . Participants will complete clinician-oriented tests. Participants of both groups will be evaluated before and after the application of respective interventions at the end of 8th week. Data will be analysed.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

June 24, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

goniometry, plyometric exercises, resistance training

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rating scale

    NPRS consists of a scale with 0-10 readings. The zero denotes no pain while 1, 2, 3 denotes to mild pain, 4, 5, 6 denotes to moderate pain while 7-10 denotes to severe pain.

    8 Weeks

  • Goniometer

    Active Range of Motion of the patient will be assessed using universal standard goniometer for ankle plantar flexion, dorsiflexion, inversion and eversion. All ranges will be assessed in sitting position.The data will be collected at baseline ankle goniometry. Goniometry will be performed using a universal goniometer with a measuring scale marked out at two-degree interval

    8 Weeks

  • The Star Excursion Balance Test (SEBT)

    The Star Excursion Balance Test (SEBT) is a widely accepted method of assessing dynamic postural stability. The Y Balance Test (YBT) is a commercially available device for measuring balance that uses 3 (anterior, posteromedial, and posterolateral) of the 8 SEBT directions and has been advocated as a method for assessing dynamic balance.

    8 Weeks

  • 1 RM Leg Press test

    A training load that corresponds to 60-80% of one repetition maximum to increase muscle strength in leg and ankle of subjects with a loading range of 10-12 repetitions. It will measure the strength in pre treatment and post treatment evaluation

    8 Weeks

Study Arms (2)

Resistance Exercises with Plyometric exercises

EXPERIMENTAL

We will apply protocol for 8 weeks 24 Sessions (3 sessions in a week). Resistive training will start in the form of manual resistive exercise for dorsiflexion, plantar flexion, eversion and inversion (manual resistance was applied for 3 to 5 seconds for ten repetitions in each cardinal plane). While controlling the time that a maximal contraction will maintained, the therapist will assure that the targeted musculature will being maximally loaded. Resistance will be applied to the dorsum of the foot just above the toes to resist dorsiflexion and to the plantar surface of the foot at the metatarsals to resist plantar flexion. After resistance training the athletes will go for plyometric exercises and will follow the following guidelines.Tubing Exercises and Plyometric Ankle Jumps Ankle Circles. Move just your foot and ankle, not your leg. Vary the stretch by tracing out the letters of the alphabet with your big toe.

Other: Resistance Exercises with Plyometric exercises

Resistance Exercises without Plyometric exercises

ACTIVE COMPARATOR

We will apply protocol for 8 weeks 24 Sessions (3 sessions in a week).We will apply protocol for 8 weeks 24 Sessions (3 sessions in a week) and 10 sec rest between each segment, 3 sets of 10 repetitions. Resistive training will start in the form of manual resistive exercise for dorsiflexion, plantar flexion, eversion and inversion (manual resistance was applied for 3 to 5 seconds for ten repetitions in each cardinal plane). Active weight bearing exercises in the form of heel rise and toe rise will performed for ten repetitions each. Towel curl and marble pick up was performed at the end of the session for ten repetitions.

Other: Resistance Exercises without Plyometric exercises

Interventions

We will apply protocol for 8 weeks 24 Sessions (3 sessions in a week) and 10 sec rest between each segment, 3 sets of 10 repetitions. Resistive training will start in the form of manual resistive exercise for dorsiflexion, plantar flexion, eversion and inversion (manual resistance was applied for 3 to 5 seconds for ten repetitions in each cardinal plane).After resistance training the athletes will go for plyometric exercises and will follow the following guidelines.Tubing Exercises,Plyometric Ankle Jumps Ankle Circles

Resistance Exercises with Plyometric exercises

We will apply protocol for 8 weeks 24 Sessions (3 sessions in a week) and 10 sec rest between each segment, 3 sets of 10 repetitions. Resistive training will start in the form of manual resistive exercise for dorsiflexion, plantar flexion, eversion and inversion (manual resistance was applied for 3 to 5 seconds for ten repetitions in each cardinal plane). While controlling the time that a maximal contraction will be maintained, the therapist will assure that the targeted musculature will being maximally loaded

Resistance Exercises without Plyometric exercises

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A history of at least 1 substantial ankle sprain with associated inflammatory symptoms and at least 1 interrupted day of desired physical activity, multiple episodes of the ankle "giving way," recurrent sprain, and "feelings of instability" in the 6 months before the study. Patients scoring the FAAM, there should be two scores, less than the ADL subscale and the Sports subscale, 20/21 items and 7/8 items must be completed, respectively
  • If both ankles qualified, the ankle with the highest score (i.e. the most severely affected ankle) was considered the involved limb.

You may not qualify if:

  • Volunteers were excluded if they had sustained an acute lower extremity injury in the 3 months before the study
  • Having participated in formal rehabilitation in the 3 months before the study
  • Having a history of lower extremity surgery or fracture that required alignment in the involved limb
  • Having any diagnosed neurologic dysfunction, such as multiple sclerosis, Parkinson disease, or head injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Pakistan sports board complex

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (14)

  • Tanen L, Docherty CL, Van Der Pol B, Simon J, Schrader J. Prevalence of chronic ankle instability in high school and division I athletes. Foot Ankle Spec. 2014 Feb;7(1):37-44. doi: 10.1177/1938640013509670. Epub 2013 Nov 27.

    PMID: 24287210BACKGROUND
  • Brown CN, Mynark R. Balance deficits in recreational athletes with chronic ankle instability. J Athl Train. 2007 Jul-Sep;42(3):367-73.

    PMID: 18059992BACKGROUND
  • Chan KW, Ding BC, Mroczek KJ. Acute and chronic lateral ankle instability in the athlete. Bull NYU Hosp Jt Dis. 2011;69(1):17-26.

    PMID: 21332435BACKGROUND
  • Yu P, Mei Q, Xiang L, Fernandez J, Gu Y. Differences in the locomotion biomechanics and dynamic postural control between individuals with chronic ankle instability and copers: a systematic review. Sports Biomech. 2022 Apr;21(4):531-549. doi: 10.1080/14763141.2021.1954237. Epub 2021 Aug 19.

    PMID: 34412557BACKGROUND
  • Hall EA, Docherty CL, Simon J, Kingma JJ, Klossner JC. Strength-training protocols to improve deficits in participants with chronic ankle instability: a randomized controlled trial. J Athl Train. 2015 Jan;50(1):36-44. doi: 10.4085/1062-6050-49.3.71. Epub 2014 Nov 3.

    PMID: 25365134BACKGROUND
  • Anderson K, Behm DG. The impact of instability resistance training on balance and stability. Sports Med. 2005;35(1):43-53. doi: 10.2165/00007256-200535010-00004.

    PMID: 15651912BACKGROUND
  • Fakontis C, Iakovidis P, Kasimis K, Lytras D, Koutras G, Fetlis A, Algiounidis I. Efficacy of resistance training with elastic bands compared to proprioceptive training on balance and self-report measures in patients with chronic ankle instability: A systematic review and meta-analysis. Phys Ther Sport. 2023 Nov;64:74-84. doi: 10.1016/j.ptsp.2023.09.009. Epub 2023 Sep 30.

    PMID: 37801793BACKGROUND
  • Wang B, Zhang X, Zhu F, Zhu W, Wang X, Jia F, Chen W, Zhang M. A randomized controlled trial comparing rehabilitation with isokinetic exercises and Thera-Band strength training in patients with functional ankle instability. PLoS One. 2022 Dec 1;17(12):e0278284. doi: 10.1371/journal.pone.0278284. eCollection 2022.

    PMID: 36454876BACKGROUND
  • Lee HM, Oh S, Kwon JW. Effect of Plyometric versus Ankle Stability Exercises on Lower Limb Biomechanics in Taekwondo Demonstration Athletes with Functional Ankle Instability. Int J Environ Res Public Health. 2020 May 22;17(10):3665. doi: 10.3390/ijerph17103665.

    PMID: 32456048BACKGROUND
  • Ismail MM, Ibrahim MM, Youssef EF, El Shorbagy KM. Plyometric training versus resistive exercises after acute lateral ankle sprain. Foot Ankle Int. 2010 Jun;31(6):523-30. doi: 10.3113/FAI.2010.0523.

    PMID: 20557819BACKGROUND
  • Luan L, Adams R, Witchalls J, Ganderton C, Han J. Does Strength Training for Chronic Ankle Instability Improve Balance and Patient-Reported Outcomes and by Clinically Detectable Amounts? A Systematic Review and Meta-Analysis. Phys Ther. 2021 Jul 1;101(7):pzab046. doi: 10.1093/ptj/pzab046.

    PMID: 33517464BACKGROUND
  • Molla-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.

    PMID: 34058832BACKGROUND
  • Matheny LM, Clanton TO. Rasch Analysis of Reliability and Validity of Scores From the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2020 Feb;41(2):229-236. doi: 10.1177/1071100719884554. Epub 2019 Oct 30.

    PMID: 31665926BACKGROUND
  • Lins-Kusterer L, Valdelamar J, Aguiar CVN, Menezes MS, Netto EM, Brites C. Validity and reliability of the 36-Item Short Form Health Survey questionnaire version 2 among people living with HIV in Brazil. Braz J Infect Dis. 2019 Sep-Oct;23(5):313-321. doi: 10.1016/j.bjid.2019.08.001. Epub 2019 Sep 3.

    PMID: 31491370BACKGROUND

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Atif Javed, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Atif Javed, PP-DPT

CONTACT

Anam Dalawar, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
the investigator and participant will be blind.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

August 14, 2024

Study Start

June 14, 2024

Primary Completion

September 14, 2024

Study Completion

September 14, 2024

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations