Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-55
SponsorCairo University
About this trial
The purpose of this study is to compare the effects of the Otago Exercise Program versus Sensorimotor Training on dynamic postural stability and risk of fall in patients with type 2 diabetes mellitus.
Participants will be randomly assigned into two equal intervention groups. One group will receive the Otago Exercise Program, while the other group will receive Sensorimotor Training. Both groups will participate in their respective exercise protocols for 8 weeks. Dynamic postural stability and the risk of falling will be assessed before and after the intervention period using standardized physical therapy evaluation tools.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with type 2 diabetes mellitus for at least 5 years.
Body Mass Index (BMI) ranging from 18.0 to 27.4 kg/m2.
Age between 45 and 55 years.
Clinically and medically stable.
Disqualifiers
Severe diabetic complications (e.g., advanced neuropathy with complete loss of protective sensation, active foot ulcers, or lower limb amputations).
Neurological disorders affecting balance other than diabetic neuropathy (e.g., stroke, Parkinson's disease, or multiple sclerosis).
Musculoskeletal conditions severely affecting lower limb function (e.g., severe osteoarthritis, recent lower limb fractures, or major orthopedic surgery).
Severe visual impairment not corrected by glasses or corrective lenses.
Trial design
Design model
Parallel
Treatments tested in this trial
Otago Exercise Program
BehavioralThe Otago Exercise Program consists of individually tailored progressive muscle-strengthening exercises (targeting lower limbs) and balance retraining exercises. Participants will perform the exercises 3 times per week for a total duration of 8 weeks. Each session lasts approximately 30 to 45 minutes under the direct supervision of a physical therapist.
Sensorimotor Training
BehavioralSensorimotor Training involves progressive dynamic balance and proprioceptive exercises performed on various surfaces (such as stable floor, foam pads, and balance boards) with sensory progression (eyes open/closed). Participants will perform the exercises 3 times per week for a total duration of 8 weeks. Each session lasts approximately 30 to 45 minutes under the direct supervision of a physical therapist.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Otago Exercise GroupExperimental treatment 1 intervention
Group B: Sensorimotor Training GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
A 14-item clinical scale used to assess dynamic postural balance, functional mobility, and balance control across four domains (anticipatory, reactive postural control, sensory orientation, and dynamic gait). Total scores range from 0 to 28, where higher scores indicate better balance and lower fall risk.
Time frame
Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).2
Falls Efficacy Scale-International (FES-I)
A 16-item questionnaire used to assess concern about falling during basic and complex daily activities. Scores range from 16 to 64, where higher scores reflect higher concern/fear of falling.
Time frame
Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).Secondary outcomes
1
Fasting Blood Glucose (FBG)
Assessed via lab blood sample to monitor glycemic control.
Time frame
Baseline and after 8 weeks of intervention.Other outcomes
1
Body Mass Index (BMI)
Calculated as weight in kilograms divided by height in meters squared (kg/m\^2) using a standardized weight and height scale, according to the World Health Organization (WHO) criteria.
Time frame
Baseline (Pre-intervention)2
Glycated Hemoglobin (HbA1c)
Assessed via laboratory venous blood sample analysis to measure average glycemic control over the preceding 2 to 3 months and confirm type 2 diabetes baseline status.
Time frame
Baseline (Pre-intervention)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: