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Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06399224
Enrollment
80
Registered
2024-05-03
Start date
2024-05-06
Completion date
2024-08-10
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Disorders

Keywords

Hemiplegic elderly

Brief summary

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

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.

Interventions

DEVICELocal Plantar vibrator

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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
65 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Berg balance scaleThrough 12 weeksIt 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.
Time up and go testThrough 12 weeksThe 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

MeasureTime frameDescription
Stroke specific quality of life scaleThrough 12 weeksIt 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.
Modified barthel indexThough 12 weeksIt 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.
Ankle PROMThough 12 weeksThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026