NCT06849076

Brief Summary

The aim of the study is to investigate the effect of talocrural joint manipulation on the ankle proprioception of patients with stroke.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2025

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

First Submitted

Initial submission to the registry

February 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 22, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

Proprioception

Outcome Measures

Primary Outcomes (1)

  • Ankle Proprioception

    The effect of talocrural joint manipulation on ankle proprioception will be evaluated using the Cybex isokinetic dynamometer. The device will analyze the passive joint position sense of the ankle in various positions.

    Change from baseline ankle proprioception immediately after the intervention

Secondary Outcomes (1)

  • Ankle Dorsiflexion Measurement

    Change from baseline ankle dorsiflexion immediately after the intervention

Study Arms (2)

Placebo Talocrural Joint Manipulation Group

PLACEBO COMPARATOR

In this group, patients will receive placebo talocrural joint manipulation. The application will be similar to that in the experimental group, however, hands will be positioned to avoid creating traction or manipulation force, and this position will be maintained for 20 seconds.

Other: Placebo Talocrural Joint Manipulation

Talocrural Joint Manipulation Group

EXPERIMENTAL

In this group, talocrural joint manipulation will be applied. After positioning the patient, high velocity low amplitude traction will be applied.

Other: Talocrural Joint Manipulation

Interventions

This technique, aiming to increase ankle dorsiflexion and mechanoreceptor activation, is based on the application of high velocity low amplitude traction to the joint.

Talocrural Joint Manipulation Group

This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.

Placebo Talocrural Joint Manipulation Group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Two months or longer elapsed since the stroke,
  • A Mini-Mental State Examination score of 24 or higher,
  • Being between 45 and 75 years of age,
  • Having a Brunnstrom stage of 4 or above

You may not qualify if:

  • The presence of severe osteoarthritis in the lower extremity,
  • The presence of cancer or diabetic neuropathy,
  • The presence of vestibular disorder,
  • The presence of lower extremity ulceration or amputation,
  • Hemodynamic instability,
  • The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
  • Having experienced an acute lower extremity injury in the last six weeks,
  • History of lower extremity surgery
  • Lack of available range of motion values required for the ankle proprioception test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (TĂ¼rkiye)

RECRUITING

Related Publications (28)

  • Vorkas PA, Shalhoub J, Lewis MR, Spagou K, Want EJ, Nicholson JK, Davies AH, Holmes E. Metabolic Phenotypes of Carotid Atherosclerotic Plaques Relate to Stroke Risk: An Exploratory Study. Eur J Vasc Endovasc Surg. 2016 Jul;52(1):5-10. doi: 10.1016/j.ejvs.2016.01.022. Epub 2016 May 23.

    PMID: 27231199BACKGROUND
  • Mansfield A, Inness EL, Mcilroy WE. Stroke. Handb Clin Neurol. 2018;159:205-228. doi: 10.1016/B978-0-444-63916-5.00013-6.

    PMID: 30482315BACKGROUND
  • Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006 Jan;86(1):30-8. doi: 10.1093/ptj/86.1.30.

    PMID: 16386060BACKGROUND
  • de Haart M, Geurts AC, Huidekoper SC, Fasotti L, van Limbeek J. Recovery of standing balance in postacute stroke patients: a rehabilitation cohort study. Arch Phys Med Rehabil. 2004 Jun;85(6):886-95. doi: 10.1016/j.apmr.2003.05.012.

    PMID: 15179641BACKGROUND
  • Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.

    PMID: 12161823BACKGROUND
  • Li J, Zhong D, Ye J, He M, Liu X, Zheng H, Jin R, Zhang SL. Rehabilitation for balance impairment in patients after stroke: a protocol of a systematic review and network meta-analysis. BMJ Open. 2019 Jul 19;9(7):e026844. doi: 10.1136/bmjopen-2018-026844.

    PMID: 31326927BACKGROUND
  • Goto Y, Otaka Y, Suzuki K, Inoue S, Kondo K, Shimizu E. Incidence and circumstances of falls among community-dwelling ambulatory stroke survivors: A prospective study. Geriatr Gerontol Int. 2019 Mar;19(3):240-244. doi: 10.1111/ggi.13594. Epub 2019 Jan 8.

    PMID: 30623545BACKGROUND
  • Darekar A, McFadyen BJ, Lamontagne A, Fung J. Efficacy of virtual reality-based intervention on balance and mobility disorders post-stroke: a scoping review. J Neuroeng Rehabil. 2015 May 10;12:46. doi: 10.1186/s12984-015-0035-3.

    PMID: 25957577BACKGROUND
  • Liu H, Yin H, Yi Y, Liu C, Li C. Effects of different rehabilitation training on balance function in stroke patients: a systematic review and network meta-analysis. Arch Med Sci. 2023 Jun 21;19(6):1671-1683. doi: 10.5114/aoms/167385. eCollection 2023.

    PMID: 38058731BACKGROUND
  • Buvarp D, Rafsten L, Abzhandadze T, Sunnerhagen KS. A cohort study on longitudinal changes in postural balance during the first year after stroke. BMC Neurol. 2022 Aug 30;22(1):324. doi: 10.1186/s12883-022-02851-7.

    PMID: 36042404BACKGROUND
  • An M, Shaughnessy M. The effects of exercise-based rehabilitation on balance and gait for stroke patients: a systematic review. J Neurosci Nurs. 2011 Dec;43(6):298-307. doi: 10.1097/JNN.0b013e318234ea24.

    PMID: 22089406BACKGROUND
  • Oliveira CB, Medeiros IR, Greters MG, Frota NA, Lucato LT, Scaff M, Conforto AB. Abnormal sensory integration affects balance control in hemiparetic patients within the first year after stroke. Clinics (Sao Paulo). 2011;66(12):2043-8. doi: 10.1590/s1807-59322011001200008.

    PMID: 22189728BACKGROUND
  • Powden CJ, Hogan KK, Wikstrom EA, Hoch MC. The Effect of 2 Forms of Talocrural Joint Traction on Dorsiflexion Range of Motion and Postural Control in Those With Chronic Ankle Instability. J Sport Rehabil. 2017 May;26(3):239-244. doi: 10.1123/jsr.2015-0152. Epub 2016 Aug 24.

    PMID: 27632835BACKGROUND
  • Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.

    PMID: 24679362BACKGROUND
  • Pellow JE, Brantingham JW. The efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains. J Manipulative Physiol Ther. 2001 Jan;24(1):17-24. doi: 10.1067/mmt.2001.112015.

    PMID: 11174691BACKGROUND
  • Dananberg HJ, Shearstone J, Guillano M. Manipulation method for the treatment of ankle equinus. J Am Podiatr Med Assoc. 2000 Sep;90(8):385-9. doi: 10.7547/87507315-90-8-385.

    PMID: 11021048BACKGROUND
  • Fisher BE, Piraino A, Lee YY, Smith JA, Johnson S, Davenport TE, Kulig K. The Effect of Velocity of Joint Mobilization on Corticospinal Excitability in Individuals With a History of Ankle Sprain. J Orthop Sports Phys Ther. 2016 Jul;46(7):562-70. doi: 10.2519/jospt.2016.6602. Epub 2016 Jun 6.

    PMID: 27266885BACKGROUND
  • Picelli A, Tamburin S, Cavazza S, Scampoli C, Manca M, Cosma M, Berto G, Vallies G, Roncari L, Melotti C, Santilli V, Smania N. Relationship between ultrasonographic, electromyographic, and clinical parameters in adult stroke patients with spastic equinus: an observational study. Arch Phys Med Rehabil. 2014 Aug;95(8):1564-70. doi: 10.1016/j.apmr.2014.04.011. Epub 2014 May 2.

    PMID: 24792138BACKGROUND
  • Cho KH, Lee HJ, Lee WH. Intra- and inter-rater reliabilities of measurement of ultrasound imaging for muscle thickness and pennation angle of tibialis anterior muscle in stroke patients. Top Stroke Rehabil. 2017 Jul;24(5):368-373. doi: 10.1080/10749357.2017.1285745. Epub 2017 Feb 15.

    PMID: 28198659BACKGROUND
  • Picelli A, Bonetti P, Fontana C, Barausse M, Dambruoso F, Gajofatto F, Girardi P, Manca M, Gimigliano R, Smania N. Is spastic muscle echo intensity related to the response to botulinum toxin type A in patients with stroke? A cohort study. Arch Phys Med Rehabil. 2012 Jul;93(7):1253-8. doi: 10.1016/j.apmr.2012.02.005. Epub 2012 Apr 12.

    PMID: 22502807BACKGROUND
  • Heckmatt JZ, Leeman S, Dubowitz V. Ultrasound imaging in the diagnosis of muscle disease. J Pediatr. 1982 Nov;101(5):656-60. doi: 10.1016/s0022-3476(82)80286-2.

    PMID: 7131136BACKGROUND
  • Pillen S, van Keimpema M, Nievelstein RA, Verrips A, van Kruijsbergen-Raijmann W, Zwarts MJ. Skeletal muscle ultrasonography: Visual versus quantitative evaluation. Ultrasound Med Biol. 2006 Sep;32(9):1315-21. doi: 10.1016/j.ultrasmedbio.2006.05.028.

    PMID: 16965971BACKGROUND
  • Picelli A, Bonetti P, Fontana C, Barausse M, Dambruoso F, Gajofatto F, Tamburin S, Girardi P, Gimigliano R, Smania N. Accuracy of botulinum toxin type A injection into the gastrocnemius muscle of adults with spastic equinus: manual needle placement and electrical stimulation guidance compared using ultrasonography. J Rehabil Med. 2012 May;44(5):450-2. doi: 10.2340/16501977-0970.

    PMID: 22549655BACKGROUND
  • Gao F, Grant TH, Roth EJ, Zhang LQ. Changes in passive mechanical properties of the gastrocnemius muscle at the muscle fascicle and joint levels in stroke survivors. Arch Phys Med Rehabil. 2009 May;90(5):819-26. doi: 10.1016/j.apmr.2008.11.004.

    PMID: 19406302BACKGROUND
  • Maganaris CN, Baltzopoulos V. Predictability of in vivo changes in pennation angle of human tibialis anterior muscle from rest to maximum isometric dorsiflexion. Eur J Appl Physiol Occup Physiol. 1999 Feb;79(3):294-7. doi: 10.1007/s004210050510.

    PMID: 10048637BACKGROUND
  • Manal K, Roberts DP, Buchanan TS. Optimal pennation angle of the primary ankle plantar and dorsiflexors: variations with sex, contraction intensity, and limb. J Appl Biomech. 2006 Nov;22(4):255-63. doi: 10.1123/jab.22.4.255.

    PMID: 17293622BACKGROUND
  • Raj IS, Bird SR, Shield AJ. Reliability of ultrasonographic measurement of the architecture of the vastus lateralis and gastrocnemius medialis muscles in older adults. Clin Physiol Funct Imaging. 2012 Jan;32(1):65-70. doi: 10.1111/j.1475-097X.2011.01056.x. Epub 2011 Sep 25.

    PMID: 22152081BACKGROUND
  • Fryer GA, Mudge JM, McLaughlin PA. The effect of talocrural joint manipulation on range of motion at the ankle. J Manipulative Physiol Ther. 2002 Jul-Aug;25(6):384-90. doi: 10.1067/mmt.2002.126129.

    PMID: 12183696BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • ömer dursun, Asst. Prof.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR
  • burak mavuÅŸ, M.Sc.

    Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • merve tunçdemir, Asst. Prof.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ömer dursun, Asst. Prof.

CONTACT

burak mavuÅŸ, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The patients enrolled in the study will receive placebo talocrural joint traction and talocrural joint traction in a randomized sequence. The order of the interventions will be determined by flipping a coin.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 22, 2025

First Posted

February 27, 2025

Study Start

April 14, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations