NCT06020131

Brief Summary

The aim of the study is to investigate the effectiveness of thoracic mobility versus lumbopelvic stabilization exercises combined with ankle strengthening exercises with resistive band on patients with chronic ankle instability in terms of lower extremity flexibility, proprioception and dynamic balance.The participants were divided into two group as Thoracic Mobility group (n=15) and Lumbopelvic Stability group (n=15). In addition their exercise programs (2 times/wk, 8 wk duration), both groups were given home exercise ankle strengthening exercises.(3 sets/ 10 reps, 3 times/wk.)

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 Nov 2022

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

November 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

April 30, 2023

Last Update Submit

August 27, 2023

Conditions

Keywords

chronic ankle instabilitydynamic balanceproprioceptionflexibilitythoracic mobilitylumbopelvic stability

Outcome Measures

Primary Outcomes (1)

  • Cumberland Ankle Instability Tool (CAIT)

    CAIT is questionnaire' has 9 items with scores ranging from 0 to 30, with lower scores indicating worse stability

    8 weeks

Secondary Outcomes (3)

  • Active Straight Leg Raise Test

    8 weeks

  • Y Balance Test

    8 weeks

  • Joint Position Sense Test

    8 weeks

Study Arms (2)

Thoracic Mobility Group

EXPERIMENTAL

Thoracic Mobility Exercises Ankle Strengthening Home Exercises with resistive band

Procedure: Thoracic Mobility RehabilitationProcedure: Ankle Strengthening Home Exercises

Lumbopelvic Stability Group

EXPERIMENTAL

Lumbopelvic stabilization exercises Ankle Strengthening Home Exercises with resistive band

Procedure: Lumbopelvic Stability RehabilitationProcedure: Ankle Strengthening Home Exercises

Interventions

Thoracic mobility exercises: Thoracic extension on foam roller, Sidelying thoracic rotation, Quadruped thoracic rotation, Squat with extension and rotation ( 10 reps x 3 set - 2 times x wk - 8 wk)

Thoracic Mobility Group

Lumbopelvic Stabilization Exercises : Bridge with alternate leg, Single leg bridge, Four point kneeling with arm and leg extension, Side plank on front arm with knee flexed (right, left), Sitting on a Swiss Ball and hip flexion (10 reps x 3 set - 2times/wk - 8 wk)

Lumbopelvic Stability Group

Ankle Strengthening exercises with resistive band (dorsiflexion, plantarflexion, inversion, eversion) (10 reps x 3 set - 3 times/wk)

Lumbopelvic Stability GroupThoracic Mobility Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being older than 18 years
  • Having at least two previous lateral ankle sprain of same ankle.
  • At least one episode of "giving way" wtihin previous 6 months.
  • Having persistent symptoms during functional activities and being free of.
  • Symptoms from any previous lower limb injuries.
  • No other lower extremity injuries.

You may not qualify if:

  • Having any systemic illness (eg. Rheumatoid arthritis, DM).
  • Any surgery history related to fractures or disorders.
  • Getting steroid injection or physiotherapy intervention previous 6 months.
  • Being a pregnant and existence of tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Noi Physio Pilates Studio

Istanbul, Ataşehir, Turkey (Türkiye)

Location

Related Publications (36)

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    PMID: 31385837BACKGROUND
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    PMID: 36634453BACKGROUND
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    PMID: 25365134BACKGROUND
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    PMID: 23306414BACKGROUND
  • Rodriguez-Merchan EC. Chronic ankle instability: diagnosis and treatment. Arch Orthop Trauma Surg. 2012 Feb;132(2):211-9. doi: 10.1007/s00402-011-1421-3. Epub 2011 Nov 5.

    PMID: 22057817BACKGROUND
  • 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
  • Xue X, Tao W, Xu X, Jin Z, Li Q, Wang Y, Gu X, Wang R, Hua Y. Do exercise therapies restore the deficits of joint position sense in patients with chronic ankle instability? A systematic review and meta-analysis. Sports Med Health Sci. 2023 Jan 23;5(1):67-73. doi: 10.1016/j.smhs.2023.01.001. eCollection 2023 Mar.

    PMID: 36994176BACKGROUND
  • Kosik KB, McCann RS, Terada M, Gribble PA. Therapeutic interventions for improving self-reported function in patients with chronic ankle instability: a systematic review. Br J Sports Med. 2017 Jan;51(2):105-112. doi: 10.1136/bjsports-2016-096534. Epub 2016 Nov 2.

    PMID: 27806951BACKGROUND
  • McCann RS, Crossett ID, Terada M, Kosik KB, Bolding BA, Gribble PA. Hip strength and star excursion balance test deficits of patients with chronic ankle instability. J Sci Med Sport. 2017 Nov;20(11):992-996. doi: 10.1016/j.jsams.2017.05.005. Epub 2017 May 25.

    PMID: 28595864BACKGROUND
  • Sciascia A, Cromwell R. Kinetic chain rehabilitation: a theoretical framework. Rehabil Res Pract. 2012;2012:853037. doi: 10.1155/2012/853037. Epub 2012 May 14.

    PMID: 22666599BACKGROUND
  • Lee J-I, Kim T-H. Effects of hip joint strengthening exercises and lumbopelvic stabilization exercises on balance and instability of adults with functional ankle instability. International Journal of Human Movement and Sports Sciences. 2021;9(4):757-764. doi:10.13189/saj.2021.090421

    BACKGROUND
  • Terada M, Pietrosimone BG, Gribble PA. Alterations in neuromuscular control at the knee in individuals with chronic ankle instability. J Athl Train. 2014 Sep-Oct;49(5):599-607. doi: 10.4085/1062-6050-49.3.28. Epub 2014 Aug 21.

    PMID: 25144597BACKGROUND
  • Khalaj N, Vicenzino B, Heales LJ, Smith MD. Is chronic ankle instability associated with impaired muscle strength? Ankle, knee and hip muscle strength in individuals with chronic ankle instability: a systematic review with meta-analysis. Br J Sports Med. 2020 Jul;54(14):839-847. doi: 10.1136/bjsports-2018-100070. Epub 2020 Jan 14.

    PMID: 31937576BACKGROUND
  • Jeong H-J, Kim B-J. The effect of thoracic joint mobilization on the changes of the thoracic kyphosis angle and static and dynamic balance. Biomedical Science Letters. 2019;25(2):149-158. doi:10.15616/bsl.2019.25.2.149

    BACKGROUND
  • Cruz-Diaz D, Lomas-Vega R, Osuna-Perez MC, Contreras FH, Martinez-Amat A. Effects of 6 Weeks of Balance Training on Chronic Ankle Instability in Athletes: A Randomized Controlled Trial. Int J Sports Med. 2015 Aug;36(9):754-60. doi: 10.1055/s-0034-1398645. Epub 2015 May 13.

    PMID: 25969966BACKGROUND
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    BACKGROUND
  • Vuurberg G, Kluit L, van Dijk CN. The Cumberland Ankle Instability Tool (CAIT) in the Dutch population with and without complaints of ankle instability. Knee Surg Sports Traumatol Arthrosc. 2018 Mar;26(3):882-891. doi: 10.1007/s00167-016-4350-4. Epub 2016 Oct 6.

    PMID: 27714439BACKGROUND
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    PMID: 26039033BACKGROUND
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    PMID: 19627942BACKGROUND
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    BACKGROUND
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    PMID: 34123527BACKGROUND
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  • 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.

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    BACKGROUND
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    BACKGROUND
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Study Officials

  • Ecem Nur TAKINDI, MSc

    Yeditepe University, Institute of Health Science, Sports Physiotherapy Department

    PRINCIPAL INVESTIGATOR
  • Elif Tuğçe ÇİL, PhD

    Yeditepe University, Institute of Health Science, Sports Physiotherapy Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The sample of study consist of patients with chronic ankle instability who gets 27 and less point from Cumberland Ankle Instability Tool. The study was conducted between November 2022 - January 2023 in Noi Physio Pilates Studio in İstanbul.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2023

First Posted

August 31, 2023

Study Start

November 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 15, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Participants were included to study accorcing to Informed Consent Form (ICF). Datas and informations were recorded.

Shared Documents
ICF
Time Frame
8 week
Access Criteria
Informed consent form was used for gathering demographic information from participants. Cumberland Ankle Instability Tool (CAIT) was used for assesing chronic ankle instability. Cut off value was determined as ≤27 points.

Locations