Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2019-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study; To determine the immediate effect on fall risk and postural stability of vibration applied to the plantar region in stroke patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Plantar Vibration on Static and Dynamic Balance

NCT03784768

Stroke Patients

COMPLETED NA

The Effect of Plantar Vibration Stimuli on the Balance of Older Women

NCT01040442

Deficit Elderly Women With Body Balance

COMPLETED NA

Sensory Augmentation Methods in Stroke

NCT03988400

Stroke

COMPLETED EARLY_PHASE1

Plantar Sensation, Position Sense, and Weight-Bearing Asymmetry Related to Balance and Mobility Post-Stroke

NCT07065292

Chronic Stroke Sensory Impairments Postural Control +1 more

RECRUITING

Validity Reliability of 3 Meter Backward Walk Test in Stroke Patients

NCT04229914

Stroke Syndrome Balance; Distorted Walking, Difficulty

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the vibration group and the placebo group.Patients will be taken to the placebo and vibration group respectively in order of arrival. If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

30 stroke patients will be included in this study. The patients who meet the inclusion criteria will be divided randomly into 2 groups as vibration (n=15) and placebo (n=15).The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vibration group

plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.

Group Type EXPERIMENTAL

vibration group

Intervention Type OTHER

plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.

placebo group

the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.

Group Type ACTIVE_COMPARATOR

placebo group

Intervention Type OTHER

the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vibration group

plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.

Intervention Type OTHER

placebo group

the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cognitive and non-communication problems
* Volunteer to join the work
* Those with less than 150 kilos
* Spasticity according to a Modified Scale Ashworth 2 and 3 patients treated with Botox
* Patients at least 8 weeks after stroke diagnosis

Exclusion Criteria

* People who are not stable due to vital signs
* Open wounds under the soles of the feet
* Being spastic at the level that will block the base touch
* Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
* 20 seconds independent standing
* Mini Mental Test score below 24
* Multiple sclerosis, Parkinson's disease, etc.
* Those with vision problems
* Patients with thoracolumbar surgery
* Patients with spinal canal stenosis

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No