Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

NCT06399224 | Completed

• 1 other identifier: Vibration on hemiplegia
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Balance Disorders

Keywords

Hemiplegic elderly

Outcome Measures

Primary Outcomes (2)

• 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.

  Through 12 weeks

• 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.

  Through 12 weeks

Secondary Outcomes (3)

• Stroke specific quality of life scale

  Through 12 weeks

• Modified barthel index

  Though 12 weeks

• Ankle PROM

  Though 12 weeks

Study Arms (2)

Planter vibrator with otago exercise

ACTIVE COMPARATOR

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

Otago exercise

ACTIVE COMPARATOR

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

Local Plantar vibrator DEVICE

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

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

Planter vibrator with otago exercise

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

Otago exercise; Planter vibrator with otago exercise

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Giza, Egypt

Location

Related Publications (2)

• 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.

  PMID: 29740561 BACKGROUND

• 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.

  PMID: 36339194 BACKGROUND

Study Officials

• A.M Baky, Professor

  faculty of physical therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: May 6, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 10, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)