Type 2 Diabetes Mellitus (DM)NCT07854496
Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes
A study testing Otago Exercise Program and Sensorimotor Training in people with Type 2 Diabetes Mellitus (DM) and Accidental Falls, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (DM), Accidental Falls, Postural Balance
- What is being tested?
- Otago Exercise Program and Sensorimotor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: OTAGO VERSUS SENSORIMOTOR TRAINING ON DYNAMIC POSTURAL STABILITY AND RISK OF FALL IN DIABETIC PATIENTS.
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.
- Being tested
- Otago Exercise Program, Sensorimotor Training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramBehavioural
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.
Sensorimotor TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sensorimotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 8 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (DM)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omneya Mohamed Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854496
- Sponsor's protocol ID
- P.T.REC/012/006643
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OTAGO VERSUS SENSORIMOTOR TRAINING ON DYNAMIC POSTURAL STABILITY AND RISK OF FALL IN DIABETIC PATIENTS.
- ClinicalTrials.gov ID
- NCT07854496
- Acronym / sponsor ID
- P.T.REC/012/006643
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Group | Experimental | Behavioral: Otago Exercise ProgramPatients in this group will undergo the Otago Exercise Program, including balance and strength training exercises, 3 times per week for 8 weeks. |
| Sensorimotor Training Group | Experimental | Behavioral: Sensorimotor TrainingPatients in this group will undergo Sensorimotor Training focusing on progressive proprioceptive and dynamic balance exercises, 3 times per week for 8 weeks. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otago Exercise ProgramThe 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. | Behavioural | Otago Exercise Group |
| Sensorimotor TrainingSensorimotor 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. | Behavioural | Sensorimotor Training Group |
Primary outcome
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
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.
Falls Efficacy Scale-International (FES-I)
Time frame: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
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.
1 secondary outcome
Fasting Blood Glucose (FBG)
Time frame: Baseline and after 8 weeks of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program and Sensorimotor Training in people with Type 2 Diabetes Mellitus (DM) and Accidental Falls, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mini-Balance Evaluation Systems Test (Mini-BESTest) (time frame: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.