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| Name | Class |
|---|---|
| Cigli Regional Training Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Group :8-week supervised exercise program, 3 times per week. | Active Comparator | 8-week supervised strengthening and stretching program performed three times weekly |
|
| Exercise Plus Self-Myofascial Release Group | Experimental | An 8-week supervised strengthening and stretching exercise program performed three times per week combined with self-myofascial release applied to the plantar fascia and gastrosoleus muscles using a foam roller before exercise sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Foot Function Index (FFI) | The Foot Function Index will be used to assess pain and disability related to foot function. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Single-Leg Stance Test (Eyes Open and Eyes Closed) | Static balance will be assessed using the single-leg stance test under eyes-open and eyes-closed conditions. | Baseline and 8 weeks |
| Timed Up and Go Test (TUG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sümena HAREKET KARAKAYA, PT | Contact | +905397264665 | SumenaHareket4@gmail.com | |
| Müge KIRMIZI, PhD | Contact | +905056013348 | mugekirmizi1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sevtap GUNAY UÇURUM, Prof | Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakırçay University Çiğli Regional Education Hospital | Recruiting | Izmir | İzmir | TR-35620 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34776128 | Result | Freire Ribeiro DL, Medeiros FVA, Marinho EBA, Ferreira Junior JB, Bottaro MF, Carmo JC. Effects of myofascial release of the ankle plantar flexors on static postural balance of young men: A randomized clinical trial. J Bodyw Mov Ther. 2021 Oct;28:121-125. doi: 10.1016/j.jbmt.2021.07.034. Epub 2021 Aug 19. | |
| 34054254 | Result |
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Data sharing plans have not yet been determined. De-identified individual participant data may be shared upon reasonable request following publication, subject to institutional and ethical approval.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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A Randomized Controlled Trial
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| Self-Myofascial Release | Other | 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. |
|
Functional mobility will be evaluated using the Timed Up and Go test.
| Baseline and 8 weeks |
| Unilateral Heel-Rise Test | Calf muscle endurance will be assessed using the unilateral heel-rise test. | Baseline and 8 weeks |
| Berg Balance Scale (BBS) | Balance performance will be assessed using the Berg Balance Scale. | Baseline and 8 weeks |
| 10-Meter Walk Test (Single-Task and Dual-Task) | 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). | Baseline and 8 weeks |
| Plantar Fascia Thickness | Plantar fascia thickness will be measured using ultrasonography. | Baseline and 8 weeks |
| Ranbhor AR, Prabhakar AJ, Eapen C. Immediate effect of foam roller on pain and ankle range of motion in patients with plantar fasciitis: A randomized controlled trial. Hong Kong Physiother J. 2021 Jun;41(1):25-33. doi: 10.1142/S1013702521500025. Epub 2020 Oct 8. |
| 33044364 | Result | Kiyono R, Onuma R, Yasaka K, Sato S, Yahata K, Nakamura M. Effects of 5-Week Foam Rolling Intervention on Range of Motion and Muscle Stiffness. J Strength Cond Res. 2022 Jul 1;36(7):1890-1895. doi: 10.1519/JSC.0000000000003757. Epub 2020 Oct 9. |
| 36990015 | Result | Cakici R, Saldiran TC, Kara I, Acik H. Plantar fascia stiffness in patients with type 2 diabetes mellitus: Stiffness effect on fall risk and gait speed. Foot (Edinb). 2023 Sep;56:102020. doi: 10.1016/j.foot.2023.102020. Epub 2023 Mar 17. |
| 35616852 | Result | Konrad A, Nakamura M, Tilp M, Donti O, Behm DG. Foam Rolling Training Effects on Range of Motion: A Systematic Review and Meta-Analysis. Sports Med. 2022 Oct;52(10):2523-2535. doi: 10.1007/s40279-022-01699-8. Epub 2022 May 26. |
| D004700 | Endocrine System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |