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Chronic Ankle InstabilityNCT06020131

Effect Of Thoracic Mobility Versus Lumbopelvic Stabilization Exercises On Patients With Chronic Ankle Instability

A study testing Thoracic Mobility Rehabilitation, Lumbopelvic Stability Rehabilitation and Ankle Strengthening Home Exercises in people with Chronic Ankle Instability, run by Yeditepe University at 1 site in Turkey (Türkiye).

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

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… 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?
Thoracic Mobility Rehabilitation, Lumbopelvic Stability Rehabilitation and Ankle Strengthening Home Exercises
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2022to 15 Jan 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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Noi Physio Pilates Studio

    Istanbul, Ataşehir

Other trials in Turkey (Türkiye)

About this study

Official title: Effect Of Thoracic Mobility Versus Lumbopelvic Stabilization Exercises On Lower Extremity Flexibility, Dynamic Balance And Proprioception In Patients With Chronic Ankle Instability

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.)

Read the detailed description

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 study were conducted in Noi Physio Pilates Studio in Istanbul between November 2022 - January 2023 during 8 weeks. 30 volunteers with chronic ankle instability were included according to Cumberland Ankle Instability Tool (CAIT). The cut off value for the CAIT test was determined as 27. Participants who received 27 or less than this value were included in the study. All participants were right dominant. Lower extremity flexibility was assessed with Active Straight Leg Raise Test, proprioception (hip, knee, ankle) was assessed with Joint Position Sense Test using electronic goniometer. Determined angles for joints; hip flexion angle as 75°, knee flexion angle as 50° and ankle dorsiflexion as 10° plantarflexion as 40°.Y Balance Test (anterior, posterolateral, posteromedial) was used for evaluating dynamic balance. 30 participants were divided into two groups as thoracic mobility and lumbopelvic stability group. Both groups were given ankle strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions. Thoracic mobility group was given; thoracic extension on foam roller, sidelying thoracic rotation, quadruped thoracic rotation, squat with extension and rotation. Lumbopelvic stabilization group was prescribed; 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.Sessions took approximately 50 minutes and exercise program was planned twice a week for 8 weeks, 16 sessions total. Both groups were given ankle strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions.

Being tested
Thoracic Mobility Rehabilitation, Lumbopelvic Stability Rehabilitation, Ankle Strengthening Home Exercises
Keywords
chronic ankle instability, dynamic balance, proprioception, flexibility, thoracic mobility, lumbopelvic stability

What participants receive

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

  • Thoracic Mobility RehabilitationProcedure or surgery

    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)

  • Lumbopelvic Stability RehabilitationProcedure or surgery

    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)

  • Ankle Strengthening Home ExercisesProcedure or surgery

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

Study groups in NCT06020131
Study groupRoleWhat they receive
Thoracic Mobility GroupExperimentalThoracic Mobility Exercises Ankle Strengthening Home Exercises with resistive band
Receives: Procedure: Thoracic Mobility Rehabilitation; Procedure: Ankle Strengthening Home Exercises
Lumbopelvic Stability GroupExperimentalLumbopelvic stabilization exercises Ankle Strengthening Home Exercises with resistive band
Receives: Procedure: Lumbopelvic Stability Rehabilitation; Procedure: Ankle Strengthening Home Exercises

What is being measured

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

  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

    Measured: 8 weeks

Secondary outcomes (3)
  1. Active Straight Leg Raise Test

    It is used for evaluation of lower extremity flexibility.

    Measured: 8 weeks

  2. Y Balance Test

    Dynamic balance test for right and left leg including three directions (anterior, posterolateral, posteromedial)

    Measured: 8 weeks

  3. Joint Position Sense Test

    It is a test for measuring proprioception of joints. (Hip, knee, ankle)

    Measured: 8 weeks

Timeline

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

  1. First posted31 Aug 2023
  2. Study start1 Nov 2022
  3. Primary completion1 Jan 2023
  4. Study completion15 Jan 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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06020131
Sponsor's protocol ID
ecemnur
Status last verified
Aug 2023
First submitted
30 Apr 2023
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participants were included to study accorcing to Informed Consent Form (ICF). Datas and informations were recorded.

Publications

  • Herzog 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 31135209
  • Al-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 27843798
  • Hertel J, Corbett RO. An Updated Model of Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):572-588. doi: 10.4085/1062-6050-344-18. Epub 2019 Jun 4.

    PubMed 31162943
  • Kobayashi T, Gamada K. Lateral Ankle Sprain and Chronic Ankle Instability: A Critical Review. Foot Ankle Spec. 2014 Aug 1;7(4):298-326. doi: 10.1177/1938640014539813. Epub 2014 Jun 24.

    PubMed 24962695
  • Hiller CE, Kilbreath SL, Refshauge KM. Chronic ankle instability: evolution of the model. J Athl Train. 2011 Mar-Apr;46(2):133-41. doi: 10.4085/1062-6050-46.2.133.

    PubMed 21391798
  • Chen ET, Borg-Stein J, McInnis KC. Ankle Sprains: Evaluation, Rehabilitation, and Prevention. Curr Sports Med Rep. 2019 Jun;18(6):217-223. doi: 10.1249/JSR.0000000000000603.

    PubMed 31385837
  • Vuurberg G, Hoorntje A, Wink LM, van der Doelen BFW, van den Bekerom MP, Dekker R, van Dijk CN, Krips R, Loogman MCM, Ridderikhof ML, Smithuis FF, Stufkens SAS, Verhagen EALM, de Bie RA, Kerkhoffs GMMJ. Diagnosis, treatment and prevention of ankle sprains: update of an evidence-based clinical guideline. Br J Sports Med. 2018 Aug;52(15):956. doi: 10.1136/bjsports-2017-098106. Epub 2018 Mar 7.

    PubMed 29514819
  • Cleland JA, Mintken PE, McDevitt A, Bieniek ML, Carpenter KJ, Kulp K, Whitman JM. Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2013;43(7):443-55. doi: 10.2519/jospt.2013.4792. Epub 2013 Apr 29.

    PubMed 23628755
  • 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
  • Needle AR, Tinsley JE, Cash JJ, Koeval BK, Barton JA, Howard JS. The effects of neuromuscular electrical stimulation to the ankle pronators on neural excitability & functional status in patients with chronic ankle instability. Phys Ther Sport. 2023 Mar;60:1-8. doi: 10.1016/j.ptsp.2022.12.001. Epub 2022 Dec 9.

    PubMed 36634453
  • 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.

    PubMed 25365134
  • Donovan L, Hertel J. A new paradigm for rehabilitation of patients with chronic ankle instability. Phys Sportsmed. 2012 Nov;40(4):41-51. doi: 10.3810/psm.2012.11.1987.

    PubMed 23306414
  • 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.

    PubMed 22057817
  • 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.

    PubMed 34058832
  • 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.

    PubMed 36994176

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic Mobility Rehabilitation, Lumbopelvic Stability Rehabilitation and Ankle Strengthening Home Exercises in people with Chronic Ankle Instability, run by Yeditepe University at 1 site in Turkey (Türkiye).

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 4 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 31 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 Turkey (Türkiye). 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: 8 weeks). 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 NCT06020131, which also lists 36 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 31 Aug 2023.

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