Balance Disorders Clinical Trial
Official title:
Effect of Planter Vibration and Otago Exercise on Risk of Fall and Quality of Life in Hemiplegic Elderly
This study aims to determine effect of Plantar vibration and Otago exercise on risk of fall and quality of life in hemiplegic elderly
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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
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
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 |
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