- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05781776
Otago Exercise Program And Gaze Stability Exercise In Older Adults
Comparison of Effects of Otago Exercise Program vs. Gaze Stability Exercise on Balance and Fear of Fall in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Riyadh, Saudi Arabia, 11433
- King Saud University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants were independent in ambulation
- They were performing activities of daily living independently
- They had impaired balance having Berg Balance Scale (BBS) score between 35-45
- They had dynamic Gait Index score between 11-19
- They had mini-mental status exam scores > 22
Exclusion Criteria:
- severe vision or hearing impairment,
- neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson's disease, etc.,
- muscular disorders which limit functional activity (Osteoarthritis, Rheumatoid arthritis, etc.),
- taking medications that affect balance,
- severe cardiovascular conditions,
- recent Lower limb injury or Surgery,
- obesity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Otago exercise program group
Participants performed Otago exercise program and core muscle strengthening exercises for eight weeks (thrice a week).
|
Otago exercise program consisted of strengthening and balance exercises. The strengthening exercises focus on major lower limb muscles. Progression of exercises was done by increasing the duration and then intensity. Balance exercises involved knee bends, backward walking, walking, and turning around, sideways walking, tandem stance (heel to toe), tandem walk (heal to toe walk), one leg stand, heel walking, toe walk, heel to toe walking backward, sit to stand and stair walking. Balance exercises progressed with varying levels of support depending on their balance and confidence. The individuals repeated each exercise 10 times. |
Active Comparator: Gaze stability exercises group
Participants performed Gaze stability exercises and core muscle strengthening exercises for eight weeks (thrice a week).
|
The exercise protocol in Gaze Stability exercises included adaptation exercises and substitution exercises. In adaptation exercises, individuals performed rapid, active head rotations while watched a visual target with the target remaining stationary. Substitution exercises, individual performed eye-head movements between targets with the goal of seeing clearly during the task. That target moved in the opposite direction of head movement. Adaptation exercises included: Horizontal and vertical (stationary target) viewing exercises done with a near target, sitting. Horizontal and vertical (stationary target) viewing exercises done with near and far targets (6-10 feet), sitting. Horizontal and vertical (stationary target) viewing exercises were done with near and far targets, standing. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale (BBS)
Time Frame: 8 weeks.
|
This tool encompasses both static and dynamic balance components across 14 different activities (5 static and 9 dynamic) performed by the patient graded on varying difficulty levels for different balance conditions (sitting balance, standing up, turning around, walking on an even surface, walking on steps, and while changing body position).
The BBS utilizes an ordinal grading on a 5-point scale (0-4) to rate the 14 task items, producing a global score of 56 with the lower score assigned to poor performance (score-0) and a greater score representing the better outcomes (score-4).
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8 weeks.
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Fall efficacy Scale- International (FES-I)
Time Frame: 8 weeks.
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The FES-I form consists of 16 items related to various functional activities.
The participant is asked to rate the level of each activity on a 4-point Likert scale.
A higher score implies a greater fear of falls and lower score imply better outcomes.
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8 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Masood Khan, M.P.Th., King Saud University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MSECO4/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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