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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mediolateral Stability Index Measurement | Mediolateral stability index, evaluated using the Biodex Balance System. Mediolateral stability index scores were derived from calculations of deviations from the center of gravity in the mediolateral axis by the device. As the mediolateral index value increases, mediolateral stability decreases. No definable minimum or maximum theoretical value. | Change from baseline mediolateral stability immediately after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi | Bolu | Merkez | 14020 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16386060 | Background | 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. | |
| 12173758 | 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. |
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Before group allocation, one individual was excluded from the study due to being over 75 years of age, 29 individuals due to cognitive dysfunction, 2 individuals due to lower extremity amputation, and 90 individuals because their Brunnstrom recovery stage was below stage four.
The study was conducted in compliance with the principles outlined in the 1964 Declaration of Helsinki, and it took place at İzzet Baysal Physical Therapy and Rehabilitation Training and Research Hospital between August 2024, and December 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Talocrural Joint Manipulation Group | Patients in this group will first receive a placebo talocrural joint manipulation, followed by the actual talocrural joint manipulation after a washout period of at least 48 hours. |
| FG001 | Talocrural Joint Manipulation Group | Patients in this group will first receive the actual talocrural joint manipulation, followed by the placebo talocrural joint manipulation after a washout period of at least 48 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants were involved in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Change from baseline overall stability immediately after intervention |
|
Through study completion, an average of one week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants in the Study | All study participants were involved in the study. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asst. Prof. Ömer Dursun | Bitlis Eren University | 5426088687 | +90 | fztomrdrsn@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | May 8, 2024 | Apr 20, 2025 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2024 | Apr 20, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
| Placebo Talocrural Joint Manipulation | Other | This intervention is a classic method used to evaluate the effect of talocrural joint manipulation. |
|
| Anteroposterior Stability Index Measurement | Anteroposterior stability index, evaluated using the Biodex Balance System. Anteroposterior stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior axis by the device. As the overall anteroposterior stability value increases, anteroposterior stability decreases. No definable minimum or maximum theoretical value. | Change from baseline anteroposterior stability immediately after intervention |
| Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | The patient was asked to stand facing the wall and place their hands on the wall at shoulder width apart, with the affected foot positioned behind and the knee in full extension. Then, without lifting the back foot or compromising knee extension, the patient was instructed to reach forward as far as possible. Subsequently, the calcaneal tubercle was placed one centimeter above the floor, and the measurement was taken with a water level gauge attached to the phone. The same measurement was repeated with the knee in flexion (20 degrees or more). | Change from baseline ankle dorsiflexion range of motion immediately after intervention |
| 19628798 | 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. |
| 12574566 | 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. |
| 27632835 | 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. |
| 22610971 | 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. |
| 20886654 | 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. |
| 34512072 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Height | Mean | Standard Deviation | centimeter |
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| Weight | Mean | Standard Deviation | kilogram |
|
| OG001 | Talocrural Manipulation Only | Only the pre- and post-intervention values of the patients in this group who received real manipulation were taken into account. |
|
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| Secondary | Mediolateral Stability Index Measurement | Mediolateral stability index, evaluated using the Biodex Balance System. Mediolateral stability index scores were derived from calculations of deviations from the center of gravity in the mediolateral axis by the device. As the mediolateral index value increases, mediolateral stability decreases. No definable minimum or maximum theoretical value. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline mediolateral stability immediately after intervention |
|
|
|
| Secondary | Anteroposterior Stability Index Measurement | Anteroposterior stability index, evaluated using the Biodex Balance System. Anteroposterior stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior axis by the device. As the overall anteroposterior stability value increases, anteroposterior stability decreases. No definable minimum or maximum theoretical value. | Posted | Median | Inter-Quartile Range | units on a scale | Change from baseline anteroposterior stability immediately after intervention |
|
|
|
| Secondary | Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions | The patient was asked to stand facing the wall and place their hands on the wall at shoulder width apart, with the affected foot positioned behind and the knee in full extension. Then, without lifting the back foot or compromising knee extension, the patient was instructed to reach forward as far as possible. Subsequently, the calcaneal tubercle was placed one centimeter above the floor, and the measurement was taken with a water level gauge attached to the phone. The same measurement was repeated with the knee in flexion (20 degrees or more). | Posted | Median | Inter-Quartile Range | average of ankle dorsi flexion degree | Change from baseline ankle dorsiflexion range of motion immediately after intervention |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |