NCT07776535

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

August 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 9, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

otago exercisemultisensory integrationbalance disordergait proplemdiabeteselderlyolder adults

Outcome Measures

Primary Outcomes (3)

  • Balance: ( Time up & go test )dual task

    From enrollment to the end of treatment at 8 weeks

  • Balance: Berg Balance Scale

    From enrollment to the end of the treatment at 8 weeks

  • Gait speed (10m walk test)

    From enrollment to the end of the treatment at 8 weeks

Secondary Outcomes (3)

  • Functional reach test.

    From enrollment to the end of treatment at 8 weeks

  • Modified fall efficacy scale

    From enrollment to the end of treatment at 8 weeks

  • Toronto clinical neuropathy score

    From enrollment to the end of treatment at 8 weeks

Study Arms (3)

Otago exercise group

ACTIVE COMPARATOR

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

Other: Otago exerciseOther: 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.

Other: Multisensory integration trainingOther: conventional treatment for neuropathy

control group

ACTIVE COMPARATOR

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

Other: conventional treatment for neuropathy

Interventions

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

Otago exercise group

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.

Multisensory integration training group

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

Multisensory integration training groupOtago exercise groupcontrol group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Qenayat Central Hospital

Zagazig, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gehad Ali Abd-Elhasseb, Assistant Professor

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Eman Mohamed El-Sayed Deif, consultant internal medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Toka Adel Mohammed Fahmy, physiotherapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 20, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 20, 2026

Record last verified: 2026-08

Locations