Clinical trial NCT06848153: Effect of Plantar Vibration in Stroke
Official title: Effect of Plantar Vibration on Ankle Proprioception in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Proprioception
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ankle Proprioception
timeFrame: Change from baseline ankle proprioception immediately and one week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
state: Merkez
Study officials:
affiliation: Bitlis Eren University
name: ömer dursun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
name: burak mavuş, M.Sc.
role: PRINCIPAL_INVESTIGATOR
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