Talocrural Joint Manipulation in Stroke

NCT ID: NCT06523010

Last Updated: 2025-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2024-11-27

Brief Summary

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The primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. The secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with stroke.

Detailed Description

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The study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive both placebo talocrural joint manipulation and talocrural joint manipulation treatments.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.

Study Groups

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Placebo Talocrural Joint Manipulation Group

Each group will receive both placebo and real talocrural joint manipulations in a randomized cross-over design. There will be a minimum interval of 48 hours between the interventions. Data obtained after the real manipulation will be recorded as the placebo comparator group data.

Group Type PLACEBO_COMPARATOR

Talocrural Joint Manipulation

Intervention Type OTHER

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

Placebo Talocrural Joint Manipulation

Intervention Type OTHER

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

Talocrural Joint Manipulation Group

Each group will receive both placebo and real talocrural joint manipulations in a randomized cross-over design. There will be a minimum interval of 48 hours between the interventions. Data obtained after the real manipulation will be recorded as the active comparison group data.

Group Type ACTIVE_COMPARATOR

Talocrural Joint Manipulation

Intervention Type OTHER

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

Placebo Talocrural Joint Manipulation

Intervention Type OTHER

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

Interventions

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Talocrural Joint Manipulation

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

Intervention Type OTHER

Placebo Talocrural Joint Manipulation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. Two months or longer elapsed since the stroke,
* 2\. A Mini-Mental State Examination score of 24 or higher,
* 3\. The ability to stand independently for 20 seconds or more,
* 4\. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
* 5\. Being between 45 and 75 years of age,
* 6\. Having a Brunnstrom stage of 4 or above

Exclusion Criteria

* 1\. The presence of severe osteoarthritis in the lower extremity,
* 2\. The presence of cancer or diabetic neuropathy,
* 3\. The presence of vestibular disorder,
* 4\. The presence of lower extremity ulceration or amputation,
* 5\. History of vertigo,
* 6\. Alcohol consumption within the last 24 hours,
* 7\. Hemodynamic instability,
* 8\. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
* 9\. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
* 10\. Having experienced an acute lower extremity injury in the last six weeks,
* 11\. History of lower extremity surgery
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Omer Dursun

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ömer dursun, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

burak mavuş, Mr.

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Locations

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Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16386060 (View on PubMed)

Yates JS, Lai SM, Duncan PW, Studenski S. Falls in community-dwelling stroke survivors: an accumulated impairments model. J Rehabil Res Dev. 2002 May-Jun;39(3):385-94.

Reference Type BACKGROUND
PMID: 12173758 (View on PubMed)

Divani AA, Vazquez G, Barrett AM, Asadollahi M, Luft AR. Risk factors associated with injury attributable to falling among elderly population with history of stroke. Stroke. 2009 Oct;40(10):3286-92. doi: 10.1161/STROKEAHA.109.559195. Epub 2009 Jul 23.

Reference Type BACKGROUND
PMID: 19628798 (View on PubMed)

Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.

Reference Type BACKGROUND
PMID: 12574566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27632835 (View on PubMed)

Hoch MC, Andreatta RD, Mullineaux DR, English RA, Medina McKeon JM, Mattacola CG, McKeon PO. Two-week joint mobilization intervention improves self-reported function, range of motion, and dynamic balance in those with chronic ankle instability. J Orthop Res. 2012 Nov;30(11):1798-804. doi: 10.1002/jor.22150. Epub 2012 May 18.

Reference Type BACKGROUND
PMID: 22610971 (View on PubMed)

Hoch MC, McKeon PO. Joint mobilization improves spatiotemporal postural control and range of motion in those with chronic ankle instability. J Orthop Res. 2011 Mar;29(3):326-32. doi: 10.1002/jor.21256. Epub 2010 Sep 30.

Reference Type BACKGROUND
PMID: 20886654 (View on PubMed)

Alamer A, Melese H, Getie K, Deme S, Tsega M, Ayhualem S, Birhanie G, Abich Y, Yitayeh Gelaw A. Effect of Ankle Joint Mobilization with Movement on Range of Motion, Balance and Gait Function in Chronic Stroke Survivors: Systematic Review of Randomized Controlled Trials. Degener Neurol Neuromuscul Dis. 2021 Sep 1;11:51-60. doi: 10.2147/DNND.S317865. eCollection 2021.

Reference Type BACKGROUND
PMID: 34512072 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BEUFTR-5

Identifier Type: -

Identifier Source: org_study_id

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