Investigation of the Effect of Intrinsic Foot Muscle Training on Plantar Pressure Distribution in Individuals With Type 2 Diabetes Mellitus

NCT05974020 | Completed

• 1 other identifier: 22-54
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this experimental randomized controlled study is to evaluate the effectiveness of the exercise program to be applied to prevent foot wounds, which is one of the leading foot problems that develop as a result of diabetes, based on foot posture and plantar pressure distribution. Participants who meet the inclusion criteria and are between the ages of 18-65 will be randomly assigned to one of the two experimental groups or the control group.Participants will be assessed through surveys to evaluate their physical activity level, foot health and functionality, and sensory status of the feet. Measurements related to foot position and posture will be taken. The use of a pedobarography device will allow for the examination of plantar pressure distribution. Following these assessments, participants will receive general foot care instructions and information on appropriate footwear, along with the designated exercise program. During routine check-ups and treatment procedures related to diabetes, blood glucose levels and HbA1c values taken from participants will be analyzed by the physician before and after the program to make comparisons. The study is planned to last for 12 weeks, and evaluations will be conducted before and after the program.

Conditions

Type 2 Diabetes (T2DM)

Keywords

exercise; plantar pressure; intrinsic mucle training; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Plantar Pressure Distribution

  Plantar pressure distribution analysis will be performed statically and dynamically with the Baropodometric Platforms Freemed™, 120 cm (Sensor Medica, Italia) pedobarography platform and software. In order to obtain the static plantar pressure distribution parameters of the people included in the study, on the surface with a pressure gauge sensor; As soon as the pressure falling on one foot reaches the value to be determined, it will be analyzed during standing static stance.

  3 months

Secondary Outcomes (1)

• Foot Posture

  3 months

Study Arms (3)

Group 1- Aerobic Exercise

EXPERIMENTAL

Group 1 participants will receive general foot care instructions and education on appropriate footwear selection, foot intrinsic muscle training, and in addition, an aerobic exercise protocol.

Other: Aerobic Exercise

Group 2- Intrinsic Muscle Training

EXPERIMENTAL

Group 2 participants will receive general foot care instructions and education on appropriate footwear selection, along with an exercise protocol focusing on foot intrinsic muscle training.

Other: Intrinsic Muscle Training

Group 3- Control Group

EXPERIMENTAL

Group 3 will receive only general foot care instructions and education on appropriate footwear selection.

Other: Control

Interventions

Control OTHER

No intervention will be applied to the control group, and information will be given on general foot care instructions and the use of appropriate shoes.

Group 3- Control Group

Intrinsic Muscle Training OTHER

In addition to general foot care instructions and briefings on the use of appropriate shoes, intrinsic muscle training including alternating toe movement, toes picking up sheets, opening and closing the toes, pinching the toe separators, toe transitions and short foot exercises will be implemented. Additionaly, warm-up exercises, ankle exercises and functional exercises will be included in the program.

Group 2- Intrinsic Muscle Training

Aerobic Exercise OTHER

In addition to general foot care instructions and information on the use of appropriate shoes, warm-up exercises, ankle exercises, functional exercises and intrinsic muscle training, the participants will be given a walking program for aerobic exercise.

Group 1- Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to participate in the study voluntarily
• Be between the ages of 18-65
• Being diagnosed with type 2 diabetes
• IWGDF Risk Level 0-1 (no LOPS or PAD)

You may not qualify if:

• Refusing to participate in the study or wanting to leave the study
• Presence of severe deformity and/or orthopedic problem in the foot
• Presence of foot ulcer
• History of lower extremity surgery
• History of lower extremity amputation
• Having serious comorbidities (renal failure, severe retinopathy, cardiac problems, neurological problems)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

Related Publications (11)

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Morrison T, Jones S, Causby RS, Thoirs K. Can ultrasound measures of intrinsic foot muscles and plantar soft tissues predict future diabetes-related foot disease? A systematic review. PLoS One. 2018 Jun 15;13(6):e0199055. doi: 10.1371/journal.pone.0199055. eCollection 2018.

  PMID: 29906277 BACKGROUND

• MANN R, INMAN VT. PHASIC ACTIVITY OF INTRINSIC MUSCLES OF THE FOOT. J Bone Joint Surg Am. 1964 Apr;46:469-81. No abstract available.

  PMID: 14131426 BACKGROUND

• McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21.

  PMID: 24659509 BACKGROUND

• 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.

  PMID: 28614678 BACKGROUND

• Matos M, Mendes R, Silva AB, Sousa N. Physical activity and exercise on diabetic foot related outcomes: A systematic review. Diabetes Res Clin Pract. 2018 May;139:81-90. doi: 10.1016/j.diabres.2018.02.020. Epub 2018 Feb 23.

  PMID: 29477503 BACKGROUND

• Lung CW, Wu FL, Liao F, Pu F, Fan Y, Jan YK. Emerging technologies for the prevention and management of diabetic foot ulcers. J Tissue Viability. 2020 May;29(2):61-68. doi: 10.1016/j.jtv.2020.03.003. Epub 2020 Mar 17.

  PMID: 32197948 BACKGROUND

• Monteiro RL, Ferreira JSSP, Silva EQ, Donini A, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial. Sensors (Basel). 2020 Sep 9;20(18):5129. doi: 10.3390/s20185129.

  PMID: 32916792 BACKGROUND

• Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.

  PMID: 19896746 BACKGROUND

• Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF). Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.

  PMID: 32176445 BACKGROUND

• Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, LeMaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK. Comprehensive foot examination and risk assessment. A report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Phys Ther. 2008 Nov;88(11):1436-43. doi: 10.1093/ptj/88.11.1436. No abstract available.

  PMID: 19137633 BACKGROUND

Related Links

• Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II. Sci Rep

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dilara Akar

  Saglik Bilimleri University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: August 4, 2023
• Primary Completion: September 13, 2023
• Study Completion: November 25, 2023
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 months

Locations

TU (1)