Effect of Plantar Vibration in Stroke

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT06848153
• Lead Sponsor: Bitlis Eren University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Study Start: 2025-03-05
• Status Verified: 2025-04
• Primary Completion: 2025-04-14
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Two months or longer elapsed since the stroke,
2. A Mini-Mental State Examination score of 24 or higher,
3. Being between 45 and 75 years of age,
4. Having a Brunnstrom stage of 4 or above,
5. Ability to stand independently for 20 seconds or more,
6. Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary.

Exclusion Criteria

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. Hemodynamic instability,
6. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
7. Having experienced an acute lower extremity injury in the last six weeks,
8. History of lower extremity surgery,
9. Alcohol consumption in the last 24 hours
10. Posterior circulation stroke involving the basilar artery or cerebellum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ankle Proprioception	Change from baseline ankle proprioception immediately and one week after the intervention	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.

Trial Locations

Locations (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi; 🇹🇷 Bolu, Merkez, Turkey