ClinicalTrials.gg
Not yet recruitingNCT07776535Balance - DMUpdated Aug 20, 2026

Effects Of Otago Exercise Versus Multisensory Integration Training On Balance And Gait In Elderly With Diabetes

An interventional study of Otago exercise and Multisensory integration training in Balance, Gait and Diabetes Mellitus, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
65 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Diabetes Mellitus by Cairo University — 7 open to participants now, 9 under way, none of them phase 3. Diabetes Mellitus · Cairo University.

Planned enrollment
2nd of 26
90 · median 53
Started
2026
with 4 others
No phase
24 of 36
6 open now
Registered
35th of 36
by date

Among the 36 studies in Diabetes Mellitus by Cairo University, this one is the 2nd largest by planned enrollment of the 26 interventional ones that give a count, is one of 5 that started in 2026, is one of 24 with no phase, and was the 35th registered.

Diabetes Mellitus

8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.

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Open to participants now

7 of the 36 studies in Diabetes Mellitus by Cairo University are open now, in 1 country. Recruiting first, the newest first:

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By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.

This study: 65 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.

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.
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.

03

Conditions studied

  • Balance
  • Gait
  • Diabetes Mellitus

Browse trials for

Keywords

  • otago exercise
  • multisensory integration
  • balance disorder
  • gait proplem
  • diabetes
  • elderly
  • older adults
04

Who can participate

Ages eligible
65 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ninety elderly Patients of both genders.
  2. Their age will range from 65 to 75th.
  3. They will be diagnosed with type 2 diabetes for 5 years or more.
  4. Patients with mild \& moderate neuropathy will be included. (Based on the Toronto scale: -mild (6-8); moderate (9-11)
  5. Berg balance between (21 to \<50) patients with mild \&moderate risk of fall .
  6. Time up \& go dual task: patient takes longer than 10 sec.
  7. for these patients was ≥ 6.5% .
  8. will range from (18: 29,9 kg/m2).
  9. Able to walk independently, with or without assistive devices.

Exclusion criteria

Exclusion Criteria:

  1. Any musculoskeletal disorder affecting the lower limb (fracture of the lower limb, tumors, any infection, ligament injuries, foot injuries).
  2. Any other neurological disorder influences gait such as (stroke, Parkinson's disease, cerebellar dysfunction, ataxia, vestibular disorders)
  3. Any other cardiovascular disease (arrhythmia, cardiac pacemakers).
  4. Unstable proliferative retinopathy and visual impairments without correction.
  5. Non-diabetic neuropathy (inflammatory, disease, infections, tumors, vitamin B12 deficiency, hypothyroidism, alcoholism, injury or pressure on the nerve).
  6. The use of medications significantly impacting postural control (e.g., sedatives).
  7. Vestibular system and Cognitive disorders.
  8. Uncontrolled hypertension.
  9. Common peroneal nerve injury.
  10. Orthostatic hypotension.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Otago exercise group

    Otago exercise plus conventional treatment for neuropathy. for 3d/w for 8weeks.

    Other: Otago exercise · Other: conventional treatment for neuropathy

  • Active comparator
    Multisensory integration training group

    Multisensory integration training group with conventional treatment for neuropathy. for 3d/w for 8 weeks.

    Other: Multisensory integration training · Other: conventional treatment for neuropathy

  • Active comparator
    control group

    Only conventional treatment for neuropathy For 3d/w for 8 weeks.

    Other: conventional treatment for neuropathy

Interventions

  • OtherOtago exercise

    Exercise program consisted of ( flexibilty - strengthening - balance ) exercise for elderly. Time of each session (50:60 min). For 3d/w for 8weeks.

  • OtherMultisensory integration training

    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.

  • Otherconventional treatment for neuropathy

    conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks

06

What researchers measure

Primary outcomes

  1. Balance: ( Time up & go test )dual task

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Balance: Berg Balance Scale

    Time frame: From enrollment to the end of the treatment at 8 weeks

  3. Gait speed (10m walk test)

    Time frame: From enrollment to the end of the treatment at 8 weeks

Secondary outcomes

  1. Functional reach test.

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Modified fall efficacy scale

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. Toronto clinical neuropathy score

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 site
  • El-Qenayat Central Hospital
    Zagazig, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 1,584 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.

Counting every sponsor, half of 1,744 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2026
First posted
Aug 20, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Nov 2027
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07776535
Lead sponsor
Cairo University
Responsible party
Toka Adel Mohammed Fahmy (physiotherapist, Cairo University) — Principal investigator
First posted
Aug 20, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Toka Adel Mohammed Fahmy, physiotherapist
Contact
pttokaadel@gmail.com
+201064030561
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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