Clinical trial NCT06399224: Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients
Official title: Effect of Planter Vibration and Otago Exercise on Risk of Fall and Quality of Life in Hemiplegic Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Disorders
Keywords: Hemiplegic elderly
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 80
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Berg balance scale
timeFrame: Through 12 weeks
measure: Time up and go test
timeFrame: Through 12 weeks
Secondary outcomes:
measure: Stroke specific quality of life scale
timeFrame: Through 12 weeks
measure: Modified barthel index
timeFrame: Though 12 weeks
measure: Ankle PROM
timeFrame: Though 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: faculty of physical therapy
name: A.M Baky, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
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.