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Completed

NCT Number: NCT06399224

Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

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

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Key information

Conditions

Balance Disorders

Age range

65 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Local Plantar vibrator

Device

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

Other names: Vibrasens (Techno Concept, Loupian, France)

Otago Exercise

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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