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CompletedNCT06399224Updated Aug 21, 2024

Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

An interventional study of Local Plantar vibrator and Otago exercise in Balance Disorders, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Balance Disorders

Keywords

  • Hemiplegic elderly
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
Male
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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 · Other: Otago exercise

  • 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

Interventions

  • DeviceLocal Plantar vibrator

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

    Also known as: Vibrasens (Techno Concept, Loupian, France)

  • OtherOtago 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

06

What researchers measure

Primary outcomes

  1. Berg balance scale

    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.

    Time frame: Through 12 weeks

  2. Time up and go test

    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.

    Time frame: Through 12 weeks

Secondary outcomes

  1. Stroke specific quality of life scale

    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.

    Time frame: Through 12 weeks

  2. Modified barthel index

    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.

    Time frame: Though 12 weeks

  3. Ankle PROM

    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

    Time frame: Though 12 weeks

07

Study locations

1 site
  • Faculty of physical therapy
    Giza, Egypt
08

References and documents

Publications

  • 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. PubMed 29740561 ↗
  • 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. PubMed 36339194 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06399224
Lead sponsor
Cairo University
Responsible party
Sandra Aziz Guirguis (Doctor of Physical Therapy, Cairo University) — Principal investigator
First posted
May 3, 2024
Start date
May 6, 2024
Primary completion
Aug 5, 2024
Completion
Aug 10, 2024
Last update
Aug 21, 2024

Study contacts

A.M Baky, Professor
study director · faculty of physical therapy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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