Bakırçay University Çiğli Regional Education Hospital
Izmir, İzmir, TR-35620, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07414914
This randomized controlled trial aims to investigate the effects of adding self-myofascial release applied to the plantar fascia and gastrosoleus muscles to an exercise program on foot function, physical performance, and plantar fascia thickness in individuals with type 2 diabetes. Participants aged 30 to 65 years with controlled type 2 diabetes will be randomly allocated to either an exercise-only group or an exercise plus self-myofascial release group. Both groups will complete an eight-week supervised exercise program three times per week. The intervention group will additionally perform self-myofascial release using a foam roller before exercise sessions. Outcomes will include foot function, balance, functional mobility, gait performance, and plantar fascia thickness assessed by ultrasonography before and after the intervention.
Interested in participating?
Request Info30 year–65 year
Female
Interventional
Not applicable
Izmir, İzmir, TR-35620, Turkey (Türkiye)
Location status: Recruiting
This randomized controlled trial will investigate the effects of adding self-myofascial release applied to the plantar fascia and gastrosoleus muscles to exercise therapy on foot function, physical performance, and plantar fascia thickness in individuals with type 2 diabetes. Individuals aged 30 to 65 years with controlled type 2 diabetes diagnosed for at least one year and able to ambulate independently without assistive devices will be included.
Participants will be randomly allocated into two groups. The exercise group will receive an eight-week exercise program, while the exercise plus self-myofascial release group will receive the same exercise program combined with self-myofascial release applied to the plantar fascia and gastrosoleus muscles.
The eight-week exercise program will include supervised general strengthening exercises targeting the upper and lower extremities, back, and core muscles, as well as stretching exercises for warm up and cool down, performed three times per week. In addition, participants will be advised to perform at least 150 minutes per week of moderate-intensity walking. Adherence will be supported with an informational brochure and monitored using an exercise diary.
Self-myofascial release will be applied using a foam roller three times per week for eight weeks before the exercise sessions.
Outcome measures will include the Foot Function Index, single-leg stance test with eyes open and closed, Timed Up and Go test, unilateral heel-rise test, Berg Balance Scale, and 10-meter walk test performed under single-task and dual-task conditions, including a cognitive task (verbal fluency using words starting with the letter "k") and a motor task (continuous head rotations paced at 40 beats per minute using a metronome). Plantar fascia thickness will be assessed by ultrasonography. All assessments will be conducted before and after the eight-week intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An 8-week supervised strengthening and stretching program performed three times weekly, with advice to perform at least 150 minutes per week of moderate-intensity walking.
Self-myofascial release applied to the plantar fascia and gastrosoleus muscles using a foam roller three times per week for eight weeks before exercise sessions.
Time frame: Baseline and 8 weeks
The Foot Function Index will be used to assess pain and disability related to foot function.
Time frame: Baseline and 8 weeks
Static balance will be assessed using the single-leg stance test under eyes-open and eyes-closed conditions.
Time frame: Baseline and 8 weeks
Functional mobility will be evaluated using the Timed Up and Go test.
Time frame: Baseline and 8 weeks
Calf muscle endurance will be assessed using the unilateral heel-rise test.
Time frame: Baseline and 8 weeks
Balance performance will be assessed using the Berg Balance Scale.
Time frame: Baseline and 8 weeks
Gait performance will be assessed using the 10-meter walk test under single-task and dual-task conditions, including a cognitive task (verbal fluency using words starting with the letter "k") and a motor task (continuous head rotations paced at 40 beats per minute using a metronome).
Time frame: Baseline and 8 weeks
Plantar fascia thickness will be measured using ultrasonography.
Contact information is provided by the study sponsor or research team.
Müge KIRMIZI, PhD
CONTACT
Sümena HAREKET KARAKAYA, PT
CONTACT
Izmir Katip Celebi University
Other
The Effect of the Addition of Myofascial Release to Exercise Program on Foot Function, Physical Performance, and Plantar Fascia Thickness in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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