Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients

Balance Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06399224
• Other study ID #: Vibration on hemiplegia
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 5, 2024
• Est. completion date: September 5, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Sandra Guirguis, Doctoral
• Phone: +201221426663
• Email: sandra_sweety[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 5, 2024
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Balance Disorders

Intervention

Device:
• Local Plantar vibrator
A vibrating device that applies 80 hz vibration waves applied on the sole of the foot

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Stroke assessment of fall risk	It assesses seven stroke-specific risk factors . These comprise four impairments (impulsivity, hemi-neglect, static, and dynamic sitting balance) and three functional limitations (lowest score on three Functional Independence Measure items: transfers, problem solving, and memory). Impulsivity and hemi-neglect are scored dichotomously (0, absent; 7, present). The remaining items are scored using a 7-point scale similar to the Functional Independence Measure, but with zero indicating no impairment or deficit, and seven indicating the most severe impairment or deficit. The total score is a sum of item scores (0, low risk of falls; 49, highest risk of falls)	Through 12 weeks
Secondary	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.	Through 12 weeks
Secondary	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.	Though 12 weeks