Talocrural Joint Manipulation in Stroke

NCT06523010 | Completed Results

• 1 other identifier: BEUFTR-5
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

postural balance

Outcome Measures

Primary Outcomes (1)

• Overall Stability Index Measurement

  Overall stability index, evaluated using the Biodex Balance System. Overall stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior and mediolateral axes by the device. A lower score indicates smaller deviation and better postural stability. The assessment was conducted on a stable platform with three 20-second repetitions interspersed with 10-second rest periods. Participants remained standing during the rest periods, and the device automatically computed the average of the three repetitions. As the general stability index value increases, overall stability decreases. No definable minimum or maximum theoretical value.

  Change from baseline overall stability immediately after intervention

Secondary Outcomes (3)

• Mediolateral Stability Index Measurement

  Change from baseline mediolateral stability immediately after intervention

• Anteroposterior Stability Index Measurement

  Change from baseline anteroposterior stability immediately after intervention

• Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions

  Change from baseline ankle dorsiflexion range of motion immediately after intervention

Study Arms (2)

Placebo Talocrural Joint Manipulation Group

PLACEBO COMPARATOR

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.

Other: Talocrural Joint Manipulation; Other: Placebo Talocrural Joint Manipulation

Talocrural Joint Manipulation Group

ACTIVE COMPARATOR

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.

Other: Talocrural Joint Manipulation; Other: Placebo Talocrural Joint Manipulation

Interventions

Talocrural Joint Manipulation 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 Group; Talocrural Joint Manipulation Group

Placebo Talocrural Joint Manipulation OTHER

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

Placebo Talocrural Joint Manipulation Group; Talocrural Joint Manipulation Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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,
• \. The ability to stand independently for 20 seconds or more,
• \. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
• \. 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,
• \. History of vertigo,
• \. Alcohol consumption within the last 24 hours,
• \. Hemodynamic instability,
• \. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
• \. 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14020, Turkey (Türkiye)

Location

Related Publications (8)

• 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: 16386060 BACKGROUND

• 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.

  PMID: 12173758 BACKGROUND

• 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.

  PMID: 19628798 BACKGROUND

• 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.

  PMID: 12574566 BACKGROUND

• 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: 27632835 BACKGROUND

• 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.

  PMID: 22610971 BACKGROUND

• 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.

  PMID: 20886654 BACKGROUND

• 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.

  PMID: 34512072 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The study has some limitations. Firstly, due to the short follow-up period, the medium-and long-term effects of talocrural joint manipulation on postural stability and ankle mobility could not be evaluated. For this reason, further studies are needed to determine the medium- and long-term effects. Secondly, since accessory joint movements were not evaluated, no conclusions could be drawn regarding the effect of talocrural joint manipulation on accessory joint movements.

Results Point of Contact

• Title: Asst. Prof. Ömer Dursun
• Organization: Bitlis Eren University

fztomrdrsn@gmail.com

5426088687

Study Officials

• ömer dursun, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• burak mavuş, Mr.

  Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

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.

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: August 2, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Locations

TU (1)