NCT05770154

Brief Summary

Diabetic polyneuropathy (DPN) is a type of nerve damage that can occur in diabetics. It can cause weakness and a loss of sensation, particularly in the legs and feet. This can have an impact on muscle strength and balance, making walking more difficult and increasing the risk of falling. Evaluating ankle muscular strength and balance using quantitative and standardised tools is critical for patients with and without DPN as well as determining how much DPN affects ankle muscle strength and balance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

February 15, 2023

Last Update Submit

February 15, 2025

Conditions

Keywords

diabetes,diabetic polyneuropathyisokineticmuscle strengthdynamic balance

Outcome Measures

Primary Outcomes (1)

  • Peak torque

    Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors peak torque at different angular velocities.

    Through study completion, an average of 6 months.

Secondary Outcomes (3)

  • Power

    Through study completion, an average of 6 months.

  • Work

    Through study completion, an average of 6 months.

  • Dynamic balance

    Through study completion, an average of 6 months.

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

diabetic patient

You may qualify if:

  • Patients aged from 40 to 55 years for both gender.
  • Patients with diabetes for more than 5 years.
  • Diabetic polyneuropathy was diagnosed by a neurologist.
  • Their BMI from 18 to 24.9 kg/m2.
  • The study population must be willing to participate in the study.

You may not qualify if:

  • Patients with marked deformities of the lower limbs, foot ulcers and Charcot foot.
  • Patients with any other neurological or orthopedic diseases that may affect balance.
  • Patients with marked weakness or drop foot.
  • Patients with amputation, mental deficits, liver or renal diseases.
  • patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaa Ayoub Elimy

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Neuropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes Complications

Study Officials

  • Doaa A Elimy, phD

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Khaled T Ahmed, Ass. prof

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR
  • Wafaa A Abd Allah, phD

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR
  • Mohamed F Abdel-lateef, phD

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for basic science department., faculty of physical Therapy

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 15, 2023

Study Start

March 15, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
Study protocol

Locations