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StrokeNCT06848153

Effect of Plantar Vibration in Stroke

A study testing Plantar Vibration 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 aim of the study is to investigate the effect of plantar vibration 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?
Plantar Vibration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Mar 2025to 15 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

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,
  • Ability to stand independently for 20 seconds or more,
  • Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary.

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),
Show all 10Show fewer
  • Having experienced an acute lower extremity injury in the last six weeks,
  • History of lower extremity surgery,
  • Alcohol consumption in the last 24 hours
  • Posterior circulation stroke involving the basilar artery or cerebellum

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, 14280

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Plantar Vibration on Ankle Proprioception in Stroke Patients

The aim of the study is to investigate the effect of plantar vibration on the ankle proprioception of patients with stroke.

Read the detailed description

The study, utilizing a randomized placebo controlled design, is planned to be conducted on a minimum of 34 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive plantar vibration or placebo plantar vibration interventions.

Conditions
Stroke
Being tested
Plantar Vibration, Placebo Plantar Vibration
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.

  • Plantar VibrationOther

    The patients in the study group will receive plantar vibration intervention with a frequency of 100 Hz on the affected plantar region for 30 minutes each day over 3 consecutive days.

  • Placebo Plantar VibrationOther

    The patients in the placebo group will receive placebo plantar vibration intervention with a frequency of 100 Hz on the affected plantar region, without touching the skin, for 30 minutes each day over 3 consecutive days.

Study groups in NCT06848153
Study groupRoleWhat they receive
Placebo Vibration GroupPlacebo comparatorIn addition to the conventional treatment program, the placebo plantar vibration application will be applied to the plantar region of the patients in the placebo group. For the application, the local vibration device will be moved without touching the patient's skin while it is operational. The placebo plantar vibration will be applied for 30 minutes each day over 3 consecutive days.
Receives: Other: Placebo Plantar Vibration
Local Vibration Intervention GroupExperimentalIn addition to the conventional treatment program, the patients in this group will receive plantar vibration application on the affected plantar region, utilizing a frequency of 100 Hz. The plantar vibration will be applied for 30 minutes each day over 3 consecutive days.
Receives: Other: Plantar Vibration

What is being measured

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

  1. Ankle Proprioception

    The effect of plantar vibration 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 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.

  1. First posted26 Feb 2025
  2. Study start5 Mar 2025
  3. Primary completion14 Apr 2025
  4. Study completion15 Apr 2025

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06848153
Sponsor's protocol ID
BEUFTR-7
Status last verified
Apr 2025
First submitted
21 Feb 2025
Last updated
16 Apr 2025
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 22233167

  • Speelman 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 21750523

  • Wenning 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 10584668

  • Arene 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 19903653

  • 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

  • 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

  • Khalifeloo 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 29740561

  • Chen 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 25133141

  • Pollock 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 24756870

  • Geurts 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 16214666

  • Sajedifar 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 37949597

  • Onal 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 35462214

  • Onal 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 32992184

  • Lee 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

Questions about this trial

What is this clinical trial studying?

A study testing 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 6 inclusion and 10 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 16 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ankle Proprioception (time frame: Change from baseline ankle proprioception 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 NCT06848153, 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 16 Apr 2025.

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