Effect of Foot-ankle Exercise Using Elastic Band

NCT ID: NCT07229794

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-11-30

Brief Summary

The goal of this clinical trial is to learn if foot-ankle exercise can prevent diabetic foot ulcer incidence in patient with diabetes neuropathy. It will also learn about the effect of foot-ankle exercise on improvement of diabetes neuropathy severity, glycemic control, brain-derived neurotropic factor, walking speed, foot ankle range of motion, callus. The main questions it aims to answer are:

• Does foot-ankle exercise lower the number of diabetic ulcer incidence
• Does foot-ankle exercise lower the diabetes neuropathy severity
• Does foot-ankle exercise improve glycemic control
• Does foot-ankle exercise improve brain-derived neurotrophic factor
• Does foot-ankle exercise improve walking speed
• Does foot-ankle exercise improve foot ankle range of motion
• Does foot-ankle exercise lower the number of callus incidence

Detailed Description

Researchers will compare intervention group foot-ankle exercise used elastic band to a control group to see if foot-ankle exercise work to prevent diabetic foot ulcer incidence in patient with diabetes neuropathy

Participants will:

• Do foot-ankle exercise for three times a week with non-consecutive day for 1 year
• Report the incidence of callus and diabetic foot ulcer whenever they have

Conditions

Diabetic Foot Ulcer (DFU); Neuropathy (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

foot-ankle exercise group

The group will receive usual care with additional food-ankle exercises using elastic band supervised by professional health care three times a week for twelve weeks. After twelve weeks period the patient will continue exercising for the completion of the study (9 month) by them self with the help of foot-ankle exercise video.

Group Type: EXPERIMENTAL

foot-ankle exercise

Intervention Type: OTHER

The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a elastic band with difference thickness (0,5 mm in 12 weeks and 0,65 mm in nine month)

control group

Patient will receive usual care, with include pharmacological treatment and self care guidelines, which are maintained in both group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

foot-ankle exercise

The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a elastic band with difference thickness (0,5 mm in 12 weeks and 0,65 mm in nine month)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• type 2 diabetes
• can walk minimal 10 meters
• neuropathy diabetic

Exclusion Criteria

• stroke
• active ulcer
• fracture on foot area
• diabetic ulcer history

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Elisabeth School Health Science

OTHER

Sponsor Role: lead

Responsible Party

Maria Suryani

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

maria suryani

Role: PRINCIPAL_INVESTIGATOR

stikes elisabeth

Locations

Elisabeth clinic

Semarang, Central Java, Indonesia

Countries

Indonesia

References

Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

Reference Type: BACKGROUND

PMID: 28614678 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Stikes Elisabeth11

Identifier Type: -

Identifier Source: org_study_id