Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes

NCT07854496 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006643
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (DM); Accidental Falls; Postural Balance

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).

• 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.

  Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).

Secondary Outcomes (1)

• Fasting Blood Glucose (FBG)

  Baseline and after 8 weeks of intervention.

Other Outcomes (2)

• Body Mass Index (BMI)

  Baseline (Pre-intervention)

• Glycated Hemoglobin (HbA1c)

  Baseline (Pre-intervention)

Study Arms (2)

Otago Exercise Group

EXPERIMENTAL

Patients in this group will undergo the Otago Exercise Program, including balance and strength training exercises, 3 times per week for 8 weeks.

Behavioral: Otago Exercise Program

Sensorimotor Training Group

EXPERIMENTAL

Patients in this group will undergo Sensorimotor Training focusing on progressive proprioceptive and dynamic balance exercises, 3 times per week for 8 weeks.

Behavioral: Sensorimotor Training

Interventions

Otago Exercise Program BEHAVIORAL

The 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.

Otago Exercise Group

Sensorimotor Training BEHAVIORAL

Sensorimotor 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.

Sensorimotor Training Group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Able to ambulate independently without assistive devices.
• Mild to moderate balance impairment based on the Mini-BESTest score.
• Glycated Hemoglobin (HbA1c) level of 6.5% or higher.

You may not qualify if:

• 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.
• Vestibular disorders causing balance impairment or acute dizziness.
• Significant liver or renal impairment.
• Uncontrolled cardiovascular conditions that limit exercise participation or present safety risks during physical activity.
• Cognitive impairment preventing the ability to understand or follow exercise instructions.
• Non-compliance or intervention dropouts (e.g., patients missing more than two weeks of sessions or voluntarily withdrawing from the study).

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Degree Candidate, Department of Physical Therapy for Cardiovascular Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-08