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Investigation of the Effect of Foot Intrinsic Muscle Training in Individuals With Diabetic Foot Syndrome

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ClinicalTrials.gov Identifier: NCT05974020
Recruitment Status : Completed
First Posted : August 3, 2023
Last Update Posted : December 29, 2023
Sponsor:
Information provided by (Responsible Party):
Fatma Dilara Akar, Saglik Bilimleri Universitesi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Other: Control Other: Intrinsic Muscle Training Other: Aerobic Exercise Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigation of the Effect of Foot Intrinsic Muscle Training on Foot Posture and Plantar Pressure Distribution in Individuals With Diabetic Foot Syndrome
Actual Study Start Date : August 4, 2023
Actual Primary Completion Date : September 13, 2023
Actual Study Completion Date : November 25, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1- Aerobic Exercise
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
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.
Experimental: Group 2- Intrinsic Muscle Training
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

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.
Experimental: Group 3- Control Group
Group 3 will receive only general foot care instructions and education on appropriate footwear selection.
 Other: Control
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.


Outcome Measures
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Primary Outcome Measures :
  1. Plantar Pressure Distribution [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Foot Posture [ Time Frame: 3 months ]
    Foot Posture Index was used to evaluate the foot posture of the individuals to be included in the study. The assessment will be made by the therapist based on observation and palpation by asking individuals to stand still in a relaxed position where they feel comfortable. The talonavicular joint of the forefoot, medial longitudinal arch, and abduction/adduction of the forefoot relative to the hindfoot will be evaluated. In the hindfoot, eversion/inversion of the head of the talus, lateral malleolus, and calcaneus will be evaluated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree to participate in the study voluntarily
  • Be between the ages of 18-65
  • Being diagnosed with type 1 or type 2 diabetes

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05974020


Locations
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Turkey
Saglik Bilimleri University
Istanbul, Üsküdar, Turkey, 34674
Sponsors and Collaborators
Saglik Bilimleri Universitesi
Investigators
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Principal Investigator: Dilara Akar Saglik Bilimleri University
More Information
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Additional Information:

Publications:

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Responsible Party: Fatma Dilara Akar, Research Assistant, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT05974020    
Other Study ID Numbers: 22-54
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: December 29, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share the method and results of our study.
Supporting Materials: Study Protocol
Time Frame: 3 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatma Dilara Akar, Saglik Bilimleri Universitesi:
diabetic foot
exercise
plantar pressure
intrinsic mucle training
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies