Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

August 19, 2024 updated by: Sandra Aziz Guirguis, Cairo University

Effect of Planter Vibration and Otago Exercise on Risk of Fall and Quality of Life in Hemiplegic Elderly

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Local Plantar vibrator
A vibrating device that applies 80 hz vibration waves applied on the sole of the foot
Other Names:
  • Vibrasens (Techno Concept, Loupian, France)
Other: 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
Active Comparator: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg balance scale
Time Frame: Through 12 weeks
It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Through 12 weeks
Time up and go test
Time Frame: Through 12 weeks
The participant was instructed to sit back in the chair without arms, to stand up on the command "Go," walk 3 m to the line marked on the floor at a normal pace, turn 180°, and walk back to the chair, and sit down again on the chair,An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Through 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke specific quality of life scale
Time Frame: Through 12 weeks
It is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke.Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains.Higher scores indicate better functioning.
Through 12 weeks
Modified barthel index
Time Frame: Though 12 weeks
It is composed of the following 10 items investigating 10 functional ADLs: feeding, personal hygiene, bathing, dressing, chair-bed transfer, toileting, bladder continence, bowel continence, ambulation or wheelchair use, and stair climbing. The score for each item is attributed by the clinician who observes the patient while performing the functional task and evaluates the amount of assistance the patient requires using a 5-point Likert scale.Each activity is assigned a score from 0 to 15, indicating the patient's level of independence.Higher scores signify greater independence, while lower scores indicate dependence or the need for assistance.
Though 12 weeks
Ankle PROM
Time Frame: Though 12 weeks
The 90° was defined as the neutral position for the measurements using an ankle biplane goniometer Ankle dorsiflexion and plantarflexion from the neutral position was given either a positive or negative value
Though 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: A.M Baky, Professor, Faculty of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Actual)

August 5, 2024

Study Completion (Actual)

August 10, 2024

Study Registration Dates

First Submitted

May 1, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Vibration on hemiplegia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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