Effect of Plantar Vibration in Stroke

Bitlis Eren University

Status: Completed

Conditions: Stroke

Treatments: Other: Placebo Plantar Vibration; Other: Plantar Vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT06848153

BEUFTR-7

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Placebo Vibration Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Plantar Vibration

Local Vibration Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Plantar Vibration