NCT06198270

Brief Summary

This randomized controlled trial, conducted at the Pakistan Sports Board in Lahore from March to August 2023, investigates the impact of neuromuscular training with K-Tape on pain, range of motion, and balance in footballers with grade I and II ankle sprains. A total of 30 male participants aged 18-30, engaged in sports for at least one year with weekly training durations of 15-20 hours, are included in the study through a non-probability convenient sampling technique. The participants are divided into two groups: Group A (Control) receiving closed-chain exercises and Group B (Experimental) undergoing neuromuscular training with K-Tape. Data collection utilizes the Numeric Pain Rating Scale (NPRS) for pain, the Star Excursion Balance Test for dynamic balance, Foot and Ankle Ability Measure (FAAM)-Sport Subscale, and a goniometer for range of motion. Participants undergo three sessions of treatment per week for four weeks. The collected data will be analyzed using SPSS version 25, aiming to provide insights into the efficacy of neuromuscular training with K-Tape as a rehabilitation strategy for ankle sprains in footballers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

December 26, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

ankle sprainneuromuscular trainingclosed kinetic chainBalanceFunctions

Outcome Measures

Primary Outcomes (4)

  • Goniometer for Range of Motion

    A goniometer is a device that measures an angle or permits the rotation of an object to a definite position.

    4 weeks

  • Star balance excursion test for Balance

    The Star Excursion Balance Test is a reliable measure and a valid dynamic test to predict risk of lower extremity injury, to identify dynamic balance deficits in patients with lower extremity conditions, and to be responsive to training programs in healthy participants and those with lower extremity conditions.

    4 weeks

  • Foot and ankle ability Measure for Functional Performance

    The FAAM is a self-report measure that assesses physical function of individuals with lower leg, foot, and ankle musculoskeletal disorders. 2) Sports subscale of 8 items. For each subscale patients are asked to answer each question with a single response that most clearly describes their condition within the past week.

    4 weeks

  • Numerical Rating Pain Scale for Pain

    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).

    4 weeks

Study Arms (2)

Close Kinetic Chain Exercise

OTHER

Control Group (Close Kinetic Chain Exercise)

Other: Closed Kinetic Chain Exercise

Neuromuscular training with K-Tape

EXPERIMENTAL

Experimental Group (Neuromuscular training with K-Tape

Other: Neuromuscular Training with K Tape

Interventions

Closed chain exercise plan of 5 exercises, 10reps x 3sets of each, 3 days in a week for 4-weeks, all values measured before and after 4-weeks.

Close Kinetic Chain Exercise

Neuromuscular training plan of 5 exercises, 10reps x 3sets of each, 3 days in a week, for 4-weeks, all values measured before and after 4-weeks. Just After the session k-tape applied.

Neuromuscular training with K-Tape

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age:18-28 years
  • Football Players (Playing since one year)
  • Ankle Sprain Grade 1, 2
  • (Squeeze Test and Talar Tilt Test) performed to diagnosis ankle sprain

You may not qualify if:

  • Any Lower limb Musculoskeletal injury/Trauma
  • Ankle or lower limb fracture (since last 6months)
  • Any related systemic condition (diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54770, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 34122771BACKGROUND
  • 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.

    PMID: 34391242BACKGROUND
  • 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.

    PMID: 29061135BACKGROUND
  • 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.

    PMID: 26639734BACKGROUND
  • 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.

    PMID: 27313347BACKGROUND
  • Caldemeyer LE, Brown SM, Mulcahey MK. Neuromuscular training for the prevention of ankle sprains in female athletes: a systematic review. Phys Sportsmed. 2020 Nov;48(4):363-369. doi: 10.1080/00913847.2020.1732246. Epub 2020 Feb 28.

    PMID: 32067546BACKGROUND

MeSH Terms

Conditions

Ankle InjuriesPain

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aamir Gul Memon, MS-SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

April 10, 2023

Primary Completion

September 10, 2023

Study Completion

October 1, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations