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Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes

27. september 2026 oppdatert av: Omneya Mohamed Ahmed, Cairo University

OTAGO VERSUS SENSORIMOTOR TRAINING ON DYNAMIC POSTURAL STABILITY AND RISK OF FALL IN DIABETIC PATIENTS.

The purpose of this study is to compare the effects of the Otago Exercise Program versus Sensorimotor Training on dynamic postural stability and risk of fall in patients with type 2 diabetes mellitus.

Participants will be randomly assigned into two equal intervention groups. One group will receive the Otago Exercise Program, while the other group will receive Sensorimotor Training. Both groups will participate in their respective exercise protocols for 8 weeks. Dynamic postural stability and the risk of falling will be assessed before and after the intervention period using standardized physical therapy evaluation tools.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

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

45 år til 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus for at least 5 years.
  • Body Mass Index (BMI) ranging from 18.0 to 27.4 kg/m2.
  • Age between 45 and 55 years.
  • Clinically and medically stable.
  • Able to ambulate independently without assistive devices.
  • Mild to moderate balance impairment based on the Mini-BESTest score.
  • Glycated Hemoglobin (HbA1c) level of 6.5% or higher.

Exclusion Criteria:

  • Severe diabetic complications (e.g., advanced neuropathy with complete loss of protective sensation, active foot ulcers, or lower limb amputations).
  • Neurological disorders affecting balance other than diabetic neuropathy (e.g., stroke, Parkinson's disease, or multiple sclerosis).
  • Musculoskeletal conditions severely affecting lower limb function (e.g., severe osteoarthritis, recent lower limb fractures, or major orthopedic surgery).
  • Severe visual impairment not corrected by glasses or corrective lenses.
  • Vestibular disorders causing balance impairment or acute dizziness.
  • Significant liver or renal impairment.
  • Uncontrolled cardiovascular conditions that limit exercise participation or present safety risks during physical activity.
  • Cognitive impairment preventing the ability to understand or follow exercise instructions.
  • Non-compliance or intervention dropouts (e.g., patients missing more than two weeks of sessions or voluntarily withdrawing from the study).

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
Eksperimentell: Otago Exercise Group

Patients in this group will undergo the Otago Exercise Program, including balance and strength training exercises, 3 times per week for 8 weeks.
Atferdsmessig: Otago Exercise Program

The Otago Exercise Program consists of individually tailored progressive muscle-strengthening exercises (targeting lower limbs) and balance retraining exercises. Participants will perform the exercises 3 times per week for a total duration of 8 weeks. Each session lasts approximately 30 to 45 minutes under the direct supervision of a physical therapist.
Eksperimentell: Sensorimotor Training Group

Patients in this group will undergo Sensorimotor Training focusing on progressive proprioceptive and dynamic balance exercises, 3 times per week for 8 weeks.
Atferdsmessig: Sensorimotor Training

Sensorimotor Training involves progressive dynamic balance and proprioceptive exercises performed on various surfaces (such as stable floor, foam pads, and balance boards) with sensory progression (eyes open/closed). Participants will perform the exercises 3 times per week for a total duration of 8 weeks. Each session lasts approximately 30 to 45 minutes under the direct supervision of a physical therapist.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
Tidsramme: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).

A 14-item clinical scale used to assess dynamic postural balance, functional mobility, and balance control across four domains (anticipatory, reactive postural control, sensory orientation, and dynamic gait). Total scores range from 0 to 28, where higher scores indicate better balance and lower fall risk.
Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
Falls Efficacy Scale-International (FES-I)
Tidsramme: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).

A 16-item questionnaire used to assess concern about falling during basic and complex daily activities. Scores range from 16 to 64, where higher scores reflect higher concern/fear of falling.
Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fasting Blood Glucose (FBG)
Tidsramme: Baseline and after 8 weeks of intervention.

Assessed via lab blood sample to monitor glycemic control.
Baseline and after 8 weeks of intervention.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body Mass Index (BMI)
Tidsramme: Baseline (Pre-intervention)

Calculated as weight in kilograms divided by height in meters squared (kg/m^2) using a standardized weight and height scale, according to the World Health Organization (WHO) criteria.
Baseline (Pre-intervention)
Glycated Hemoglobin (HbA1c)
Tidsramme: Baseline (Pre-intervention)

Assessed via laboratory venous blood sample analysis to measure average glycemic control over the preceding 2 to 3 months and confirm type 2 diabetes baseline status.
Baseline (Pre-intervention)

Samarbeidspartnere og etterforskere

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

Sponsor

Cairo University

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 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

27. september 2026

Først innsendt som oppfylte QC-kriteriene

27. september 2026

Først lagt ut (Faktiske)

2. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P.T.REC/012/006643

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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