Effect of Plantar Vibration in Stroke

NCT06848153 | Completed

• 1 other identifier: BEUFTR-7
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Proprioception

Outcome Measures

Primary Outcomes (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.

  Change from baseline ankle proprioception immediately and one week after the intervention

Study Arms (2)

Placebo Vibration Group

PLACEBO COMPARATOR

In 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.

Other: Placebo Plantar Vibration

Local Vibration Intervention Group

EXPERIMENTAL

In 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.

Other: Plantar Vibration

Interventions

Plantar Vibration OTHER

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.

Local Vibration Intervention Group

Placebo Plantar Vibration OTHER

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.

Placebo Vibration Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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),
• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, 14280, Turkey (Türkiye)

Location

Related Publications (30)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ömer dursun, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• burak mavuş, M.Sc.

  Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The evaluator and the researcher administering the plantar vibration intervention will be different. Patients will be blinded to their group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 5, 2025
• Primary Completion: April 14, 2025
• Study Completion: April 15, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

TU (1)