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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06020131
Other study ID # ecemnur
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date January 15, 2023

Study information

Verified date August 2023
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.)


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 15, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Thoracic Mobility Rehabilitation
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 Rehabilitation
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 Exercises
Ankle Strengthening exercises with resistive band (dorsiflexion, plantarflexion, inversion, eversion) (10 reps x 3 set - 3 times/wk)

Locations

Country Name City State
Turkey Noi Physio Pilates Studio Istanbul Atasehir

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (36)

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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. — View Citation

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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. Erratum In: Curr Sports Med Rep. 2019 Aug;18(8):310. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Kararti C, Bilgin S, Büyükturan Ö, Büyükturan B, Dadali Y, Bek N. Lumbopelvi?k Motor Kontrol, postüral Denge ve Fiziksel Performans Arasindaki Iliski. Türk Fizyoterapi ve Rehabilitasyon Dergisi. 2019. doi:10.21653/tfrd.425735

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. — View Citation

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. — View Citation

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. — View Citation

Lee DK, Kang MH, Lee TS, Oh JS. Relationships among the Y balance test, Berg Balance Scale, and lower limb strength in middle-aged and older females. Braz J Phys Ther. 2015 May-Jun;19(3):227-34. doi: 10.1590/bjpt-rbf.2014.0096. Epub 2015 May 29. — View Citation

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

Liebenson C, Karpowicz AM, Brown SH, Howarth SJ, McGill SM. The active straight leg raise test and lumbar spine stability. PM R. 2009 Jun;1(6):530-5. doi: 10.1016/j.pmrj.2009.03.007. — View Citation

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. — View Citation

McCann RS, Johnson K, Suttmiller AMB. Lumbopelvic Stability and Trunk Muscle Contractility of Individuals with Chronic Ankle Instability. Int J Sports Phys Ther. 2021 Jun 2;16(3):741-748. doi: 10.26603/001c.22132. — View Citation

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. — View Citation

Myer GD, Chu DA, Brent JL, Hewett TE. Trunk and hip control neuromuscular training for the prevention of knee joint injury. Clin Sports Med. 2008 Jul;27(3):425-48, ix. doi: 10.1016/j.csm.2008.02.006. — View Citation

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. — View Citation

Olsson L, Lund H, Henriksen M, Rogind H, Bliddal H, Danneskiold-Samsøe B. Test-retest reliability of a knee joint position sense measurement method in sitting and prone position. Advances in Physiotherapy. 2004;6(1):37-47. doi:10.1080/14038190310009894

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. — View Citation

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. — View Citation

Tahoon A, Shendy, S, El-khozamy, H, Baky, WA. Flexibility deficit in chronic ankle instability. Case Medical Research. 2019. doi:10.31525/ct1-nct04083391

Tamura A, Shimura K, Inoue Y. Hip flexibility and dynamic balance ability in soccer players with functional ankle instability. Trauma Care. 2021;1(3):206-214. doi:10.3390/traumacare1030018

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 36 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Active Straight Leg Raise Test It is used for evaluation of lower extremity flexibility. 8 weeks
Secondary Y Balance Test Dynamic balance test for right and left leg including three directions (anterior, posterolateral, posteromedial) 8 weeks
Secondary Joint Position Sense Test It is a test for measuring proprioception of joints. (Hip, knee, ankle) 8 weeks
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