StrokeNCT06523010

Talocrural Joint Manipulation in Stroke

A study testing Talocrural Joint Manipulation in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. 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: 64 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 2 Aug 2024to 27 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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,

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu, Merkez, 14020

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Talocrural Joint Manipulation on Static Balance in 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 treatments.

Conditions: Stroke
Being tested: Talocrural Joint Manipulation, Placebo Talocrural Joint Manipulation
Keywords: postural balance
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06523010
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Talocrural Joint Manipulation; Other: Placebo Talocrural Joint Manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline overall stability immediately after intervention

Secondary outcomes (3)

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.
Measured: Change from baseline mediolateral stability immediately after intervention
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.
Measured: 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).
Measured: Change from baseline ankle dorsiflexion range of motion immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202427 Nov 2024

First posted26 Jul 2024
Study start2 Aug 2024
Primary completion27 Nov 2024
Study completion27 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06523010
Sponsor's protocol ID: BEUFTR-5
Status last verified: Jul 2025
First submitted: 22 Jul 2024
Last updated: 23 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 16386060
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.
PubMed 12173758
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.
PubMed 19628798
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.
PubMed 12574566
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.
PubMed 27632835
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.
PubMed 22610971
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.
PubMed 20886654
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.
PubMed 34512072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Talocrural Joint Manipulation on Static Balance in Patients With Stroke
ClinicalTrials.gov ID: NCT06523010
Acronym / sponsor ID: BEUFTR-5
Conditions: Stroke
Keywords: postural balance
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Bitlis Eren UniversityUniversity, hospital or other
Study start: 2 Aug 2024 (actual)
Primary completion: 27 Nov 2024 (actual)
Study completion: 27 Nov 2024 (actual)
First posted: 26 Jul 2024 (actual)
Results: Posted 23 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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: Talocrural Joint Manipulation, Other: Placebo Talocrural Joint ManipulationEach 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	Other: Talocrural Joint Manipulation, Other: Placebo Talocrural Joint ManipulationEach 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.

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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,

Key exclusion criteria (11 listed)

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,

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
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	Placebo Talocrural Joint Manipulation Group, Talocrural Joint Manipulation Group
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 Manipulation Group

Primary outcome

Overall Stability Index Measurement
Time frame: Change from baseline overall stability immediately after intervention
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.

3 secondary outcomes

Mediolateral Stability Index Measurement
Time frame: Change from baseline mediolateral stability immediately after intervention
Anteroposterior Stability Index Measurement
Time frame: Change from baseline anteroposterior stability immediately after intervention
Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions
Time frame: Change from baseline ankle dorsiflexion range of motion immediately after intervention

Results and safety

Results posted to the registry on 23 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Talocrural Joint Manipulation Group	32	32
Talocrural Joint Manipulation Group	32	32

Primary outcome: Overall Stability Index Measurement

Time frame: Change from baseline overall stability immediately after intervention. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Placebo Only n = 64	Talocrural Manipulation Only n = 64
Value	17.5 (8 to 28)	9 (2 to 22)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of one week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants in the Study	0 of 64 (0%)	0 of 64 (0%)	0 of 64

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 12173758Yates 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.
Background: PubMed 19628798Divani 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.
Background: PubMed 12574566Lamb 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.
Background: PubMed 27632835Powden 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.
Background: PubMed 22610971Hoch 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.
Background: PubMed 20886654Hoch 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.
Background: PubMed 34512072Alamer 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.

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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. This study is not recruiting at the moment.

ömer dursun, Asst. Prof. principal investigator

Bitlis Eren University

burak mavuş, Mr. principal investigator

Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

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 6 inclusion and 11 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: finished, as of the sponsor's last update on 23 Jul 2025. 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?

Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Stability Index Measurement (time frame: Change from baseline overall stability immediately after 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 NCT06523010, which also lists 8 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 23 Jul 2025.