StrokeNCT07898579
Beren Vibration Insole in Stroke Rehabilitation
A study testing Conventional Physiotherapy and Plantar Vibration in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of a custom-made vibration insole on gait, balance, and fall risk in patients with stroke. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional Physiotherapy and Plantar Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2027to 15 Nov 2027
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 2 months since stroke onset
- A Mini-Mental State Examination (MMSE) score of 24 or higher and no communication difficulties
- Ability to stand independently for at least 20 seconds
- Ability to walk 10 meters independently, with walking aids or orthoses if needed
- Age between 45 and 70 years
- Spasticity of the gastrocnemius and soleus muscles graded no higher than 2 on the Modified Ashworth Scale
- A Brunnstrom lower-extremity motor recovery stage of 4 or higher
Who cannot join
- Rigidity of the ankle plantar flexor muscles
- Severe osteoarthritis of the lower extremity
- Presence of cancer or diabetic neuropathy
- Presence of a vestibular disorder
- Lower-extremity ulceration or amputation
- History of vertigo
Show all 13Show fewer
- Alcohol consumption within the previous 24 hours
- Hemodynamic instability
- Posterior circulation stroke involving the basilar artery or cerebellum
- Presence of other neurological disorders, such as multiple sclerosis or Parkinson's disease
- Acute lower-extremity injury within the previous 6 weeks
- History of lower-extremity surgery
- Presence of foot deformity
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
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
birkan özkardaş, Mr., 5550639585 ext. 90, brknzkrds31@gmail.com
About this study
Official title: The Effect of the Beren Vibration Insole on Gait, Balance, and Fall Risk in Patients With Stroke
The aim of this study is to investigate the effects of a custom-made vibration insole on gait, balance, and fall risk in patients with stroke.
Read the detailed description
The study, utilizing a randomized controlled design, is planned to be conducted in a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. Participants will be randomly assigned to either the intervention group, receiving a custom-made vibration insole in addition to conventional physiotherapy, or the control group, receiving conventional physiotherapy alone.
- Conditions
- Stroke
- Being tested
- Conventional Physiotherapy, Plantar Vibration
- Keywords
- Balance, Gait, Fall risk
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
Participants in this group will receive conventional physiotherapy every weekday throughout the study period, including therapeutic exercises and functional electrical stimulation aimed at improving lower-extremity muscle strength and gait.
Plantar VibrationOther
Participants in this group will receive plantar vibration using a custom-made vibration insole for 30 minutes per day over three consecutive days, in addition to conventional physiotherapy throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Participants in this group will receive conventional physiotherapy five days per week, including therapeutic exercises and functional electrical stimulation to support lower-extremity function, gait, and balance rehabilitation. Receives: Other: Conventional Physiotherapy |
| Custom-Made Vibration Insole + Conventional Physiotherapy | Experimental | Participants in this group will receive conventional physiotherapy five days per week, including therapeutic exercises and functional electrical stimulation to support lower-extremity function, gait, and balance rehabilitation, in addition to plantar vibration delivered using the custom-made vibration insole for 30 minutes per day over three consecutive days. Receives: Other: Conventional Physiotherapy; Other: Plantar Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Postural Stability Index Measurement
This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline overall postural stability index immediately and one week after the intervention
Secondary outcomes (5)
Fall Risk Assessment
Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform. Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling. The test will be performed with three 30-second trials. The average of the three trials will be calculated automatically by the TechnoBody balance system.
Measured: Change from baseline fall risk immediately and one week after the intervention
Anteroposterior Stability Index Measurement
The anteroposterior stability index will be assessed by measuring deviations of the center of gravity in the anteroposterior direction. Lower scores indicate smaller deviations and better anteroposterior postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline anteroposterior stability index immediately and one week after the intervention
Mediolateral Stability Index Measurement
The mediolateral stability index will be assessed by measuring deviations of the center of gravity in the mediolateral direction. Lower scores indicate smaller deviations and better mediolateral postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline mediolateral stability index immediately and one week after the intervention
Timed Up and Go Test
The Timed Up and Go test will be used to assess dynamic balance and functional mobility. Participants will be instructed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down again. The time required to complete the task will be recorded in seconds. Shorter completion times indicate better functional mobility and dynamic balance.
Measured: Change from baseline Timed Up and Go test performance immediately and one week after the intervention
10-Meter Walk Test
Walking speed will be assessed using the 10-Meter Walk Test. Participants will be instructed to walk a 10-meter distance at their usual walking speed, and the time required to complete the test will be recorded. Walking speed will be calculated in meters per second (m/s), with higher speeds indicating better walking performance.
Measured: Change from baseline walking speed immediately and one week 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 Oct 2026
- Study start15 Jun 2027 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 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, Assoc. Prof., Principal investigator, Bitlis Eren Universityburak mavuş, M.Sc., Principal investigator, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospitaladnan demirel, Assoc. Prof., Principal investigator, Abant Izzet Baysal Universitytamer çankaya, Assoc. Prof., Principal investigator, Abant Izzet Baysal Universityerhan dincer, Asst. Prof., Principal investigator, Bitlis Eren Universitytarık koç, M.Sc., Principal investigator, Bitlis Eren Universityabdüsselam avcı, M.Sc., Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898579
- Sponsor's protocol ID
- BEUFTR-13
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
del Pozo-Cruz B, Adsuar JC, Parraca JA, del Pozo-Cruz J, Olivares PR, Gusi N. Using whole-body vibration training in patients affected with common neurological diseases: a systematic literature review. J Altern Complement Med. 2012 Jan;18(1):29-41. doi: 10.1089/acm.2010.0691. Epub 2012 Jan 10.
PubMed 22233167Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.
PubMed 21750523Wenning GK, Ebersbach G, Verny M, Chaudhuri KR, Jellinger K, McKee A, Poewe W, Litvan I. Progression of falls in postmortem-confirmed parkinsonian disorders. Mov Disord. 1999 Nov;14(6):947-50. doi: 10.1002/1531-8257(199911)14:63.0.co;2-o.
PubMed 10584668Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346.
PubMed 19903653Lamb 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 12574566Tyson 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 16386060Yates 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 12173758Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
PubMed 29740561Chen JC, Shaw FZ. Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. World J Clin Cases. 2014 Aug 16;2(8):316-26. doi: 10.12998/wjcc.v2.i8.316.
PubMed 25133141Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
PubMed 24756870Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
PubMed 16214666Sajedifar M, Fakhari Z, Naghdi S, Nakhostin Ansari N, Honarpisheh R, Nakhostin-Ansari A. Comparison of the immediate effects of plantar vibration of both feet with the plantar vibration of the affected foot on balance in patients with stroke: Preliminary findings. J Bodyw Mov Ther. 2023 Oct;36:45-49. doi: 10.1016/j.jbmt.2023.06.001. Epub 2023 Jun 5.
PubMed 37949597Onal B, Sertel M, Karaca G. Effect of plantar vibration on static and dynamic balance in stroke patients: a randomised controlled study. Physiotherapy. 2022 Sep;116:1-8. doi: 10.1016/j.physio.2022.02.002. Epub 2022 Feb 14.
PubMed 35462214Onal B, Karaca G, Sertel M. Immediate Effects of Plantar Vibration on Fall Risk and Postural Stability in Stroke Patients: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2020 Dec;29(12):105324. doi: 10.1016/j.jstrokecerebrovasdis.2020.105324. Epub 2020 Sep 28.
PubMed 32992184Lee SW, Cho KH, Lee WH. Effect of a local vibration stimulus training programme on postural sway and gait in chronic stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Oct;27(10):921-31. doi: 10.1177/0269215513485100. Epub 2013 Jul 1.
PubMed 23818408
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Beren Vibration Insole on Gait, Balance, and Fall Risk in Patients With Stroke
- ClinicalTrials.gov ID
- NCT07898579
- Acronym / sponsor ID
- BEUFTR-13
- Conditions
- Stroke
- Keywords
- Balance, Gait, Fall risk
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 Jun 2027 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 27 Oct 2026 (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 this study is to investigate the effects of a custom-made vibration insole on gait, balance, and fall risk in patients with stroke.
Detailed description
The study, utilizing a randomized controlled design, is planned to be conducted in a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. Participants will be randomly assigned to either the intervention group, receiving a custom-made vibration insole in addition to conventional physiotherapy, or the control group, receiving conventional physiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants in this group will receive conventional physiotherapy five days per week, including therapeutic exercises and functional electrical stimulation to support lower-extremity function, gait, and balance rehabilitation. |
| Custom-Made Vibration Insole + Conventional Physiotherapy | Experimental | Other: Conventional Physiotherapy, Other: Plantar VibrationParticipants in this group will receive conventional physiotherapy five days per week, including therapeutic exercises and functional electrical stimulation to support lower-extremity function, gait, and balance rehabilitation, in addition to plantar vibration delivered using the custom-made vibration insole for 30 minutes per day over three consecutive days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 2 months since stroke onset
- A Mini-Mental State Examination (MMSE) score of 24 or higher and no communication difficulties
- Ability to stand independently for at least 20 seconds
- Ability to walk 10 meters independently, with walking aids or orthoses if needed
- Age between 45 and 70 years
Key exclusion criteria (13 listed)
- Rigidity of the ankle plantar flexor muscles
- Severe osteoarthritis of the lower extremity
- Presence of cancer or diabetic neuropathy
- Presence of a vestibular disorder
- Lower-extremity ulceration or amputation
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 |
|---|---|---|
| Conventional PhysiotherapyParticipants in this group will receive conventional physiotherapy every weekday throughout the study period, including therapeutic exercises and functional electrical stimulation aimed at improving lower-extremity muscle strength and gait. | Other | Conventional Physiotherapy, Custom-Made Vibration Insole + Conventional Physiotherapy |
| Plantar VibrationParticipants in this group will receive plantar vibration using a custom-made vibration insole for 30 minutes per day over three consecutive days, in addition to conventional physiotherapy throughout the study period. | Other | Custom-Made Vibration Insole + Conventional Physiotherapy |
Primary outcome
Overall Postural Stability Index Measurement
Time frame: Change from baseline overall postural stability index immediately and one week after the intervention
This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with three trials of 30 seconds each. The average of the three trials will be automatically calculated by the TechnoBody balance system.
5 secondary outcomes
Fall Risk Assessment
Time frame: Change from baseline fall risk immediately and one week after the intervention
Anteroposterior Stability Index Measurement
Time frame: Change from baseline anteroposterior stability index immediately and one week after the intervention
Mediolateral Stability Index Measurement
Time frame: Change from baseline mediolateral stability index immediately and one week after the intervention
Timed Up and Go Test
Time frame: Change from baseline Timed Up and Go test performance immediately and one week after the intervention
10-Meter Walk Test
Time frame: Change from baseline walking speed immediately and one week 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 Oct 2026.
- Background: PubMed 22233167del Pozo-Cruz B, Adsuar JC, Parraca JA, del Pozo-Cruz J, Olivares PR, Gusi N. Using whole-body vibration training in patients affected with common neurological diseases: a systematic literature review. J Altern Complement Med. 2012 Jan;18(1):29-41. doi: 10.1089/acm.2010.0691. Epub 2012 Jan 10.
- Background: PubMed 21750523Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.
- Background: PubMed 10584668Wenning GK, Ebersbach G, Verny M, Chaudhuri KR, Jellinger K, McKee A, Poewe W, Litvan I. Progression of falls in postmortem-confirmed parkinsonian disorders. Mov Disord. 1999 Nov;14(6):947-50. doi: 10.1002/1531-8257(199911)14:63.0.co;2-o.
- Background: PubMed 19903653Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346.
- 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 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 29740561Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Background: PubMed 25133141Chen JC, Shaw FZ. Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. World J Clin Cases. 2014 Aug 16;2(8):316-26. doi: 10.12998/wjcc.v2.i8.316.
- Background: PubMed 24756870Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
- Background: PubMed 16214666Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
- Background: PubMed 37949597Sajedifar M, Fakhari Z, Naghdi S, Nakhostin Ansari N, Honarpisheh R, Nakhostin-Ansari A. Comparison of the immediate effects of plantar vibration of both feet with the plantar vibration of the affected foot on balance in patients with stroke: Preliminary findings. J Bodyw Mov Ther. 2023 Oct;36:45-49. doi: 10.1016/j.jbmt.2023.06.001. Epub 2023 Jun 5.
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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, Assoc. Prof. principal investigator
Bitlis Eren University
burak mavuş, M.Sc. principal investigator
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
adnan demirel, Assoc. Prof. principal investigator
Abant Izzet Baysal 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 Conventional Physiotherapy and Plantar Vibration 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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 27 Oct 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. 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, Assoc. 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?
Overall Postural Stability Index Measurement (time frame: Change from baseline overall postural stability index immediately and one week 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 NCT07898579, which also lists 30 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 Oct 2026.