StrokeNCT06849076
The Influence of Talocrural Manipulation on Proprioception in Stroke
A study testing Talocrural Joint Manipulation in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effect of talocrural joint manipulation on the ankle proprioception of patients with stroke. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Talocrural Joint Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu, Merkez, 14280
burak mavuş, M.Sc., 5388178351 ext. +90, a.burakmavus@gmail.com
adnan demirel, Assoc. Prof., 5334170651 ext. +90, adnandemirel231966@gmail.com
About this study
Official title: The Effect of Talocrural Joint Manipulation on Ankle Proprioception in Post-Stroke Patients
The aim of the study is to investigate the effect of talocrural joint manipulation on the ankle proprioception of patients with stroke.
Read the 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 interventions.
- Conditions
- Stroke
- Being tested
- Placebo Talocrural Joint Manipulation, Talocrural Joint Manipulation
- Keywords
- Proprioception
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Talocrural Joint ManipulationOther
This intervention is a classic method used to evaluate the effect of talocrural joint manipulation.
Talocrural Joint ManipulationOther
This technique, aiming to increase ankle dorsiflexion and mechanoreceptor activation, is based on the application of high velocity low amplitude traction to the joint.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Talocrural Joint Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline ankle proprioception immediately after the intervention
Secondary outcomes (1)
Ankle Dorsiflexion Measurement
For the measurement of dorsiflexion range of motion, patients will be asked to stand facing a wall with the assessed leg positioned at the back. They will place their hands on the wall at shoulder width. While keeping the back knee in at least 20 degrees of flexion and ensuring the foot remains in contact with the ground, they will be instructed to lean forward as far as possible. The dorsiflexion range of motion will then be measured using a spirit level application on an iPhone placed one centimeter above the calcaneal tuberosity.
Measured: Change from baseline ankle dorsiflexion immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start14 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Dursun, Bitlis Eren University
- Investigators
- ömer dursun, Asst. Prof., Principal investigator, Bitlis Eren Universityburak mavuş, M.Sc., Principal investigator, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospitalmerve tunçdemir, Asst. Prof., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849076
- Sponsor's protocol ID
- BEUFTR-6
- Status last verified
- Jul 2026
- First submitted
- 22 Feb 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27231199Mansfield A, Inness EL, Mcilroy WE. Stroke. Handb Clin Neurol. 2018;159:205-228. doi: 10.1016/B978-0-444-63916-5.00013-6.
PubMed 30482315Tyson 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.
PubMed 16386060de 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.
PubMed 15179641Mayo 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.
PubMed 12161823Li 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.
PubMed 31326927Goto 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.
PubMed 30623545Darekar 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.
PubMed 25957577Liu 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.
PubMed 38058731Buvarp 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.
PubMed 36042404An 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.
PubMed 22089406Oliveira 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.
PubMed 22189728Powden 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.
PubMed 27632835Marron-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.
PubMed 24679362Pellow 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.
PubMed 11174691
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Talocrural Joint Manipulation on Ankle Proprioception in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT06849076
- Acronym / sponsor ID
- BEUFTR-6
- Conditions
- Stroke
- Keywords
- Proprioception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the effect of talocrural joint manipulation on the ankle proprioception 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 interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Talocrural Joint Manipulation Group | Placebo comparator | Other: Placebo Talocrural Joint ManipulationIn 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. |
| Talocrural Joint Manipulation Group | Experimental | Other: Talocrural Joint ManipulationIn this group, talocrural joint manipulation will be applied. After positioning the patient, high velocity low amplitude traction will be applied. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Talocrural Joint ManipulationThis intervention is a classic method used to evaluate the effect of talocrural joint manipulation. | Other | Placebo Talocrural Joint Manipulation Group |
| Talocrural Joint ManipulationThis technique, aiming to increase ankle dorsiflexion and mechanoreceptor activation, is based on the application of high velocity low amplitude traction to the joint. | Other | Talocrural Joint Manipulation Group |
Primary outcome
Ankle Proprioception
Time frame: Change from baseline ankle proprioception immediately after the intervention
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.
1 secondary outcome
Ankle Dorsiflexion Measurement
Time frame: Change from baseline ankle dorsiflexion immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 27231199Vorkas 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.
- Background: PubMed 30482315Mansfield A, Inness EL, Mcilroy WE. Stroke. Handb Clin Neurol. 2018;159:205-228. doi: 10.1016/B978-0-444-63916-5.00013-6.
- Background: PubMed 16386060Tyson 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.
- Background: PubMed 15179641de 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.
- Background: PubMed 12161823Mayo 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.
- Background: PubMed 31326927Li 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.
- Background: PubMed 30623545Goto 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.
- Background: PubMed 25957577Darekar 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.
- Background: PubMed 38058731Liu 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.
- Background: PubMed 36042404Buvarp 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.
- Background: PubMed 22089406An 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.
- Background: PubMed 22189728Oliveira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ömer dursun, Asst. Prof. principal investigator
Bitlis Eren University
burak mavuş, M.Sc. principal investigator
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
merve tunçdemir, Asst. Prof. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talocrural Joint Manipulation in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ömer dursun, Asst. Prof. (5426088687 ext. +90, fztomrdrsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Proprioception (time frame: Change from baseline ankle proprioception immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06849076, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.