Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05781776
Other study ID # MSECO4/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date June 21, 2021

Study information

Verified date March 2023
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fall occurrences and the associated risk of injury are debilitating and major health concerns in the older population. Several interventions have been investigated and implemented to address the needs of balance impairments and to reduce the increased risk of falls. This study aimed to compare the effectiveness of the Otago exercise program (OEP) and gaze stability exercises (GSE) on balance and the risk of falls in older adults residing at an old age home facility. 30 elderly participants were equally and randomly divided into two groups: Group OEP received the OEP and group GSE received GSE for eight weeks (thrice a week). In addition, both groups also performed core muscle-strengthening exercises. The Berg balance scale (BBS) and the Fall efficacy scale-International (FES-I) were the outcome measures.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 21, 2021
Est. primary completion date February 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Otago exercises and core strengthening
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.
Gaze stability exercises and core strengthening
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.

Locations

Country Name City State
Saudi Arabia King Saud University Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Scale (BBS) 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). 8 weeks.
Primary Fall efficacy Scale- International (FES-I) 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. 8 weeks.
See also
  Status Clinical Trial Phase
Recruiting NCT04039048 - Effect of ctDCS During Balance Training on Cerebellar Ataxia N/A
Not yet recruiting NCT04105322 - Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients N/A
Completed NCT00934531 - Donepezil and the Risk of Falls in Seniors With Cognitive Impairment N/A
Completed NCT05563311 - Functional Assessment and Sleep Apnea in Obese Children and Adolescents N/A
Completed NCT03674268 - Psycometric Properties of Pushing Scale
Completed NCT03403218 - Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test N/A
Completed NCT04563182 - Relationship Between Gluteus Medius Muscle Strength, Balance and Jumping Performance in Professional Female Handball Players
Recruiting NCT05983809 - Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis. N/A
Completed NCT05779189 - Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults N/A
Completed NCT04671524 - The Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Upper Extremity Affected N/A
Completed NCT06405854 - Coordination-based Exercise Intervention in Preschool Children N/A
Not yet recruiting NCT06267833 - The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program N/A
Active, not recruiting NCT05910606 - Strong Foundations 2.0: A Digitally Delivered Fall Prevention Program. N/A
Not yet recruiting NCT05973279 - The Relationship Between Lower Limb Functionality, Knee Joint Position Sense, Balance and Falls in Haemiplegic Patients
Active, not recruiting NCT03892291 - Objective Dual-task Turning Measures for Return-to-duty Assessments
Completed NCT05043727 - Effects of Exer Gaming on Balance and Gait in Parkinson's Patients N/A
Completed NCT04014998 - Effectiveness of Virtual Reality in Patients With Chronic Neck Pain N/A
Completed NCT01698086 - Vestibular Rehabilitation for Persons With Multiple Sclerosis: Who Benefits the Most? (MSVR3trial) N/A
Completed NCT03376334 - A Pilot Study to Investigate the Effect of Motor Imagery on Dynamic Balance of Asymptomatic Students N/A
Completed NCT05319626 - Immediate Effects of Two Different Lower Limb Sensory Stimulation Strategies on Balance and Mobility in Older Adults N/A