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

17 augusti 2026 uppdaterad av: Toka Adel Mohammed Fahmy, Cairo University

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Toka Adel Mohammed Fahmy, physiotherapist
  • Telefonnummer: +201064030561
  • E-post: pttokaadel@gmail.com

Studieorter

      • Zagazig, Egypten
        • El-Qenayat Central Hospital
        • Kontakt:
          • Toka Adel Mohammed Fahmy, physiotherapist
          • Telefonnummer: +201064030561
          • E-post: pttokaadel@gmail.com

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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. HBA1C for these patients was ≥ 6.5% .
  8. BMI will range from (18: 29,9 kg/m2).
  9. Able to walk independently, with or without assistive devices.

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, autoimmune 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Otago exercise group
Otago exercise plus conventional treatment for neuropathy. for 3d/w for 8weeks.

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

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

conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
Aktiv komparator: Multisensory integration training group

Multisensory integration training group with conventional treatment for neuropathy.

for 3d/w for 8 weeks.

conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
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.
Aktiv komparator: control group
Only conventional treatment for neuropathy For 3d/w for 8 weeks.
conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Balance: ( Time up & go test )dual task
Tidsram: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Balance: Berg Balance Scale
Tidsram: From enrollment to the end of the treatment at 8 weeks
From enrollment to the end of the treatment at 8 weeks
Gait speed (10m walk test)
Tidsram: From enrollment to the end of the treatment at 8 weeks
From enrollment to the end of the treatment at 8 weeks

Sekundära resultatmått

Resultatmått
Tidsram
Functional reach test.
Tidsram: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Modified fall efficacy scale
Tidsram: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Toronto clinical neuropathy score
Tidsram: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Gehad Ali Abd-Elhasseb, Assistant Professor, Cairo University
  • Huvudutredare: Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy, Cairo University
  • Huvudutredare: Eman Mohamed El-Sayed Deif, consultant internal medicine

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 oktober 2027

Avslutad studie (Beräknad)

1 november 2027

Studieregistreringsdatum

Först inskickad

9 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2026

Första postat (Faktisk)

20 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 augusti 2026

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