Effect of Foot-ankle Exercise Using Elastic Band

St Elisabeth School Health Science

Status: Active, not recruiting

Conditions: Neuropathy (Disorder); Diabetic Foot Ulcer (DFU)

Treatments: Other: foot-ankle exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07229794

Stikes Elisabeth11

Details and patient eligibility

About

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

Full 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

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

foot-ankle exercise group

Experimental group

Description:

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.

Treatment:

Other: foot-ankle exercise

control group

No Intervention group

Description:

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