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

17. august 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

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

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

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Balance: ( Time up & go test )dual task
Tidsramme: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks
Balance: Berg Balance Scale
Tidsramme: 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)
Tidsramme: From enrollment to the end of the treatment at 8 weeks
From enrollment to the end of the treatment at 8 weeks

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

9. august 2026

Først innsendt som oppfylte QC-kriteriene

17. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • balance exercise for elderly

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