Clinical trial NCT06523010: Talocrural Joint Manipulation in Stroke
Official title: The Effect of Talocrural Joint Manipulation on Static Balance in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: postural balance
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Stability Index Measurement
timeFrame: Change from baseline overall stability immediately after intervention
Secondary outcomes:
measure: Mediolateral Stability Index Measurement
timeFrame: Change from baseline mediolateral stability immediately after intervention
measure: Anteroposterior Stability Index Measurement
timeFrame: Change from baseline anteroposterior stability immediately after intervention
measure: Ankle Dorsiflexion Range of Motion Measurement
timeFrame: Change from baseline ankle dorsiflexion range of motion immediately after intervention
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
state: Merkez
Study officials:
affiliation: Bitlis Eren University
name: ömer dursun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
name: adnan demirel, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
name: birkan özkardaş, Mr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
name: burak mavuş, Mr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.