BalanceBalance - DMNCT07776535
Effects Of Otago Exercise Versus Multisensory Integration Training On Balance And Gait In Elderly With Diabetes
A study testing Otago exercise, Multisensory integration training and conventional treatment for neuropathy in people with Balance and Gait, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effect of the Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Balance, Gait, Diabetes Mellitus
- What is being tested?
- Otago exercise, Multisensory integration training and conventional treatment for neuropathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Nov 2027
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ninety elderly Patients of both genders.
- Their age will range from 65 to 75th.
- They will be diagnosed with type 2 diabetes for 5 years or more.
- Patients with mild \& moderate neuropathy will be included. (Based on the Toronto scale: -mild (6-8); moderate (9-11)
- Berg balance between (21 to <50) patients with mild \&moderate risk of fall .
- Time up \& go dual task: patient takes longer than 10 sec.
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- HBA1C for these patients was ≥ 6.5% .
- BMI will range from (18: 29,9 kg/m2).
- Able to walk independently, with or without assistive devices.
Who cannot join
- Any musculoskeletal disorder affecting the lower limb (fracture of the lower limb, tumors, any infection, ligament injuries, foot injuries).
- Any other neurological disorder influences gait such as (stroke, Parkinson's disease, cerebellar dysfunction, ataxia, vestibular disorders)
- Any other cardiovascular disease (arrhythmia, cardiac pacemakers).
- Unstable proliferative retinopathy and visual impairments without correction.
- Non-diabetic neuropathy (inflammatory, autoimmune disease, infections, tumors, vitamin B12 deficiency, hypothyroidism, alcoholism, injury or pressure on the nerve).
- The use of medications significantly impacting postural control (e.g., sedatives).
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- Vestibular system and Cognitive disorders.
- Uncontrolled hypertension.
- Common peroneal nerve injury.
- Orthostatic hypotension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
El-Qenayat Central Hospital
Zagazig
Toka Adel Mohammed Fahmy, physiotherapist, +201064030561, pttokaadel@gmail.com
About this study
The goal of this clinical trial is to compare the effect of the Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus.
The main question it aims to answer is:
Read more
- Is there a significant difference between the effect of Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus? Researchers will compare Otago exercise to Multisensory integration training to know which one has the greatest benefit on balance \&gait in the elderly with type2 diabetes.
Participants will be divided into 3 groups; each group takes a certain training program for 8 weeks:
- First group: Otago exercise group plus conventional treatment for neuropathy.
- Second group: Multisensory integration training group plus conventional treatment for neuropathy.
- Third group: control group takes only conventional treatment for neuropathy.
Read the detailed description
Diabetes one of the most prevalent chronic non-communicable diseases. Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, affecting about 50% of diabetic patients.
DPN characterized by peripheral nerve dysfunction. It initially presents sensory symptoms like numbness and tingling, which may evolve into pain and heightened sensitivity. Subsequently, motor symptoms such as muscle weakness and coordination difficulties appear, potentially leading to muscle atrophy.
Due to all these changes affecting peripheral nerve function, the functions of the lower extremities will be disturbed, which facilitate normal posture and walking, resulting in a loss of somatosensation and proprioception. This decreased sensitivity in the feet leads to balance defects, particularly in elderly and diabetic individuals.
The Otago exercise program is effective in preventing falls in older adults by improving cognitive function, balance, strength, functional fitness, and recovery, while reducing costs. Furthermore, multisensory exercises enhance balance and mobility by targeting sensory systems, thus lowering fall risk compared to traditional methods focused on physical strength or motor skills.
Both interventions positively affect balance and mobility in older adults with type 2 diabetes, but direct comparisons of their effectiveness are limited. This study aims to fill that gap by evaluating two rehabilitation interventions, potentially aiding clinical decision-making by identifying the more effective option for enhancing postural stability and mobility.
- Conditions
- Balance, Gait, Diabetes Mellitus
- Being tested
- Otago exercise, Multisensory integration training, conventional treatment for neuropathy
- Keywords
- otago exercise, multisensory integration, balance disorder, gait proplem, diabetes, elderly, older adults
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago exerciseOther
Exercise program consisted of ( flexibilty - strengthening - balance ) exercise for elderly.
Time of each session (50:60 min). For 3d/w for 8weeks.
Multisensory integration trainingOther
Multisensory integration training is a group of balance exercise depend on facilitating different sensory systems (visual-vestibular-propioception) Time for each session (50 min). For 3d/w for 8weeks.
conventional treatment for neuropathyOther
conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Otago exercise group | Active comparator | Otago exercise plus conventional treatment for neuropathy. for 3d/w for 8weeks. Receives: Other: Otago exercise; Other: conventional treatment for neuropathy |
| Multisensory integration training group | Active comparator | Multisensory integration training group with conventional treatment for neuropathy.
for 3d/w for 8 weeks. Receives: Other: Multisensory integration training; Other: conventional treatment for neuropathy |
| control group | Active comparator | Only conventional treatment for neuropathy For 3d/w for 8 weeks. Receives: Other: conventional treatment for neuropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance: ( Time up & go test )dual task
Measured: From enrollment to the end of treatment at 8 weeks
Balance: Berg Balance Scale
Measured: From enrollment to the end of the treatment at 8 weeks
Gait speed (10m walk test)
Measured: From enrollment to the end of the treatment at 8 weeks
Secondary outcomes (3)
Functional reach test.
Measured: From enrollment to the end of treatment at 8 weeks
Modified fall efficacy scale
Measured: From enrollment to the end of treatment at 8 weeks
Toronto clinical neuropathy score
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies 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
- Model description
- patient will be assigned into three group: * first group: will take Otago exercise plus conventional treatment for neuropathy * second group: will take multisensory integration training plus conventional treatment for neuropathy. * Third group: will only take the conventional treatment for neuropathy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toka Adel Mohammed Fahmy, Cairo University
- Investigators
- Gehad Ali Abd-Elhasseb, Assistant Professor, Principal investigator, Cairo UniversityFatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy, Principal investigator, Cairo UniversityEman Mohamed El-Sayed Deif, consultant internal medicine, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776535
- Sponsor's protocol ID
- balance exercise for elderly
- Acronym
- Balance - DM
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Otago Exercise Versus Multisensory Integration Training On Balance And Gait In Elderly With Diabetes
- ClinicalTrials.gov ID
- NCT07776535
- Acronym / sponsor ID
- Balance - DM / balance exercise for elderly
- Conditions
- Balance, Gait, Diabetes Mellitus
- Keywords
- otago exercise, multisensory integration, balance disorder, gait proplem, diabetes, elderly, older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 Aug 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 goal of this clinical trial is to compare the effect of the Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus.
The main question it aims to answer is:
- Is there a significant difference between the effect of Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus? Researchers will compare Otago exercise to Multisensory integration training to know which one has the greatest benefit on balance \&gait in the elderly with type2 diabetes.
Participants will be divided into 3 groups; each group takes a certain training program for 8 weeks:
- First group: Otago exercise group plus conventional treatment for neuropathy.
- Second group: Multisensory integration training group plus conventional treatment for neuropathy.
- Third group: control group takes only conventional treatment for neuropathy.
Detailed description
Diabetes one of the most prevalent chronic non-communicable diseases. Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, affecting about 50% of diabetic patients.
DPN characterized by peripheral nerve dysfunction. It initially presents sensory symptoms like numbness and tingling, which may evolve into pain and heightened sensitivity. Subsequently, motor symptoms such as muscle weakness and coordination difficulties appear, potentially leading to muscle atrophy.
Due to all these changes affecting peripheral nerve function, the functions of the lower extremities will be disturbed, which facilitate normal posture and walking, resulting in a loss of somatosensation and proprioception. This decreased sensitivity in the feet leads to balance defects, particularly in elderly and diabetic individuals.
The Otago exercise program is effective in preventing falls in older adults by improving cognitive function, balance, strength, functional fitness, and recovery, while reducing costs. Furthermore, multisensory exercises enhance balance and mobility by targeting sensory systems, thus lowering fall risk compared to traditional methods focused on physical strength or motor skills.
Both interventions positively affect balance and mobility in older adults with type 2 diabetes, but direct comparisons of their effectiveness are limited. This study aims to fill that gap by evaluating two rehabilitation interventions, potentially aiding clinical decision-making by identifying the more effective option for enhancing postural stability and mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- patient will be assigned into three group: * first group: will take Otago exercise plus conventional treatment for neuropathy * second group: will take multisensory integration training plus conventional treatment for neuropathy. * Third group: will only take the conventional treatment for neuropathy.
| Arm | Type | Receives |
|---|---|---|
| Otago exercise group | Active comparator | Other: Otago exercise, Other: conventional treatment for neuropathyOtago exercise plus conventional treatment for neuropathy. for 3d/w for 8weeks. |
| Multisensory integration training group | Active comparator | Other: Multisensory integration training, Other: conventional treatment for neuropathyMultisensory integration training group with conventional treatment for neuropathy. for 3d/w for 8 weeks. |
| control group | Active comparator | Other: conventional treatment for neuropathyOnly conventional treatment for neuropathy For 3d/w for 8 weeks. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Ninety elderly Patients of both genders.
- Their age will range from 65 to 75th.
- They will be diagnosed with type 2 diabetes for 5 years or more.
- Patients with mild \& moderate neuropathy will be included. (Based on the Toronto scale: -mild (6-8); moderate (9-11)
- Berg balance between (21 to <50) patients with mild \&moderate risk of fall .
Key exclusion criteria (10 listed)
- Any musculoskeletal disorder affecting the lower limb (fracture of the lower limb, tumors, any infection, ligament injuries, foot injuries).
- Any other neurological disorder influences gait such as (stroke, Parkinson's disease, cerebellar dysfunction, ataxia, vestibular disorders)
- Any other cardiovascular disease (arrhythmia, cardiac pacemakers).
- Unstable proliferative retinopathy and visual impairments without correction.
- Non-diabetic neuropathy (inflammatory, autoimmune disease, infections, tumors, vitamin B12 deficiency, hypothyroidism, alcoholism, injury or pressure on the nerve).
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 exerciseExercise program consisted of ( flexibilty - strengthening - balance ) exercise for elderly. Time of each session (50:60 min). For 3d/w for 8weeks. | Other | Otago exercise group |
| Multisensory integration trainingMultisensory integration training is a group of balance exercise depend on facilitating different sensory systems (visual-vestibular-propioception) Time for each session (50 min). For 3d/w for 8weeks. | Other | Multisensory integration training group |
| conventional treatment for neuropathyconventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks | Other | Multisensory integration training group, Otago exercise group, control group |
Primary outcome
Balance: ( Time up & go test )dual task
Time frame: From enrollment to the end of treatment at 8 weeks
Balance: Berg Balance Scale
Time frame: From enrollment to the end of the treatment at 8 weeks
Gait speed (10m walk test)
Time frame: From enrollment to the end of the treatment at 8 weeks
3 secondary outcomes
Functional reach test.
Time frame: From enrollment to the end of treatment at 8 weeks
Modified fall efficacy scale
Time frame: From enrollment to the end of treatment at 8 weeks
Toronto clinical neuropathy score
Time frame: From enrollment to the end of treatment at 8 weeks
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 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Gehad Ali Abd-Elhasseb, Assistant Professor principal investigator
Cairo University
Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy principal investigator
Cairo University
Eman Mohamed El-Sayed Deif, consultant internal medicine principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago exercise, Multisensory integration training and conventional treatment for neuropathy in people with Balance and Gait, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 10 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Toka Adel Mohammed Fahmy, physiotherapist (+201064030561, pttokaadel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance: ( Time up & go test )dual task (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 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 20 Aug 2026.