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NCT Number: NCT07776535

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

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.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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).
  • Vestibular system and Cognitive disorders.
  • Uncontrolled hypertension.
  • Common peroneal nerve injury.
  • Orthostatic hypotension.

Treatment and study plan

Otago Exercise

Other

Exercise program consisted of ( flexibilty - strengthening - balance ) exercise for elderly.

Time of each session (50:60 min). For 3d/w for 8weeks.

Multisensory integration training

Other

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 neuropathy

Other

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Toka Adel Mohammed Fahmy, physiotherapist

CONTACT

[email protected]

+201064030561

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: Balance - DM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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