Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

NCT ID: NCT06399224

Last Updated: 2024-08-21

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-06

Study Completion Date

2024-08-10

Brief Summary

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This study aims to determine effect of Plantar vibration and Otago exercise on risk of fall and quality of life in hemiplegic elderly

Detailed Description

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Stroke is one of the major causes of permanent disability. Stroke can have many causes and occurs mainly in old age, Hemiplegic patients have a two-fold higher risk of falling than other patients of the same age or gender, beside fall in older adults can cause significant physical and psychological injury to the individual. Otago exercises are the interventions given for fall prevention in elderly and showed good results with hemiplegic cases as well, it is easy and could be done by old adults even at home. Plantar vibration as a cheap, portable, and easy applicable, saving time and with no effort could be a good choice as a treatment tool to be added for old hemiplegic patients treatment programme. Thus applying an easy and effective programme for old hemiplegic subjects that reduces their risk of fall and improves their balance and ADL and at the same time helps them to conduct it easily and adhere to it should be our target to full fill.

Conditions

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Balance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study group will be treated with both plantar vibration and Otago exercise whereas the control group will receive Otago exercise only. Both groups will receive a 50 minutes of otago exercise program except for the study group will take 15 minutes of plantar vibration with frequency of 80 Hz, with 10 seconds of vibration and 5 seconds of rest with total time 15 min before the Otago exercise. The frequency of the exercise will be 3 times a week for 12 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Planter vibrator with otago exercise

This group will receive15 minutes of plantar vibration with frequency of 80 Hz, with 10 seconds of vibration and 5 seconds of rest with total time 15 min before the 50 minutes Otago exercise. The frequency of the exercise will be 3 times a week for 12 weeks.

Group Type ACTIVE_COMPARATOR

Local Plantar vibrator

Intervention Type DEVICE

A vibrating device that applies 80 hz vibration waves applied on the sole of the foot

Otago exercise

Intervention Type OTHER

Warm up Front Knee strength Back knee strength Side hip strength Calf raising Toe raising Sit to stand Heel walk Toe walk One leg standing Side way walk Cool down

Otago exercise

This group will receive 50 minutes Otago exercise only. The frequency of the exercise will be 3 times a week for 12 weeks.

Group Type ACTIVE_COMPARATOR

Otago exercise

Intervention Type OTHER

Warm up Front Knee strength Back knee strength Side hip strength Calf raising Toe raising Sit to stand Heel walk Toe walk One leg standing Side way walk Cool down

Interventions

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Local Plantar vibrator

A vibrating device that applies 80 hz vibration waves applied on the sole of the foot

Intervention Type DEVICE

Otago exercise

Warm up Front Knee strength Back knee strength Side hip strength Calf raising Toe raising Sit to stand Heel walk Toe walk One leg standing Side way walk Cool down

Intervention Type OTHER

Other Intervention Names

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Vibrasens (Techno Concept, Loupian, France)

Eligibility Criteria

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Inclusion Criteria

* first-ever stroke
* age 65-75years
* duration since stroke ≥6 months
* balance deficit confirmed by one leg stance (OLS) test; patient unable to stand on affected leg for 30s with eyes open
* able to walk without the use of aids .able to understand verbal commands.

Exclusion Criteria

* participation in other treatment protocols for balance
* presence of conditions other than stroke affecting balance
* history of lower-limb surgery within the previous year
* fixed ankle contractures
* cognitive impairments (MMSE\<24)
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sandra Aziz Guirguis

Doctor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A.M Baky, Professor

Role: STUDY_DIRECTOR

faculty of physical therapy

Locations

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Faculty of physical therapy

Giza, , Egypt

Site Status

Countries

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Egypt

References

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Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.

Reference Type BACKGROUND
PMID: 29740561 (View on PubMed)

Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.

Reference Type BACKGROUND
PMID: 36339194 (View on PubMed)

Other Identifiers

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Vibration on hemiplegia

Identifier Type: -

Identifier Source: org_study_id

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