Modified Foot Exercise to Improve Sensitivity and Perfussion on Type 2 Diabetes Patients

NCT ID: NCT05408234

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-09-30

Brief Summary

Subject will be trained to do regular foot exercise during their visit to the clinic. We will evaluate foot sensitivity and peripheral perfussion after

Detailed Description

Use an 8-10 MHz Doppler probe with a gel smeared over the sensor. Place the Doppler probe on the pulse area at a 45-60° angle to the skin surface.

Move the probe to find the most precise and robust arterial pulse before inflating the cuff.

The cuff is inflated about 20 mm Hg above the point where the arterial Doppler sound disappears.

Then slowly deflate until the Doppler sound reappears and records this value. The blood pressure at which the arterial pulse reappears is the systolic pressure for that blood vessel.

If the flow is still detected at the maximum inflation rate (300 mmHg), the cuff should be deflated immediately to avoid pain.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smart Foot Exercise

The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).

The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.

The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.

Movement using newspaper media, namely by:

Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.

The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.

Group Type: EXPERIMENTAL

Smart Foot Exercise

Intervention Type: OTHER

The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).

The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.

The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.

Movement using newspaper media, namely by:

Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.

The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.

Interventions

Smart Foot Exercise

The patient lies supine (supine) with the legs raised 450 while supported for 1-3 minutes until blanching occurs (the skin becomes pale).

The patient sits on the edge of the bed with the legs hanging down and then performs dorsiflexion, plantarflexion, inversion, and eversion for 3 minutes until the skin appears red.

The patient lies supine with the legs covered with a blanket for 3-5 minutes. This whole cycle is repeated 3-6 times per session, and each session is repeated 2-4 times a day.

Movement using newspaper media, namely by:

Place a sheet of newspaper on the floor, then shape the sheet into a ball with both feet.

The ball shape is then opened into a sheet as before with both feet. Tear the newspaper into two parts, and separate the two parts of the newspaper. Tear the first newspaper into small pieces with both feet. Remove the bunch of stubs and place them in a second, whole newspaper. Wrap everything into a ball shape with both feet. This step is enough to do once.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diabetes Mellitus Type 2

Exclusion Criteria

• Chronic Heart Failure
• Chronic Kidney Diseae

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Sebelas Maret

OTHER

Sponsor Role: lead

Responsible Party

Nurhasan Agung Prabowo

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurhasan Agung Prabowo, MD

Role: PRINCIPAL_INVESTIGATOR

Universitas Sebelas Maret

Locations

RS UNS (Universitas Sebelas Maret Hospital)

Surakarta, Central Java, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Nurhasan Agung Prabowo, MD

Role: CONTACT

dr.Nurhasan21@staff.uns.ac.id

6282328010430

Facility Contacts

Nurhasan Agung Prabowo, MD

Role: primary

dr.Nurhasan21@staff.uns.ac.id

082328010430

Other Identifiers

FootExercise

Identifier Type: -

Identifier Source: org_study_id