[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624844":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":54,"overallOfficials":64,"centralContacts":69,"locations":79,"responsibleParty":98,"collaborators":102,"id":105,"slug":32,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":32,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":32,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":82,"whyStopped":32,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Izmir Katip Celebi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Foot Function Index (FFI)","The Foot Function Index will be used to assess pain and disability related to foot function.","Baseline and 8 weeks",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"Timed Up and Go Test (TUG)","Functional mobility will be evaluated using the Timed Up and Go test.",{"measure":21,"description":22,"timeFrame":12},"Unilateral Heel-Rise Test","Calf muscle endurance will be assessed using the unilateral heel-rise test.",{"measure":24,"description":25,"timeFrame":12},"Berg Balance Scale (BBS)","Balance performance will be assessed using the Berg Balance Scale.",{"measure":27,"description":28,"timeFrame":12},"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).",{"measure":30,"description":31,"timeFrame":12},"Plantar Fascia Thickness","Plantar fascia thickness will be measured using ultrasonography.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","A Randomized Controlled Trial","TREATMENT",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","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.\n\nParticipants 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.\n\nThe 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.\n\nSelf-myofascial release will be applied using a foam roller three times per week for eight weeks before the exercise sessions.\n\nOutcome 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.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Exercise Group :8-week supervised exercise program, 3 times per week.","ACTIVE_COMPARATOR","8-week supervised strengthening and stretching program performed three times weekly",[47],"Behavioral: Exercise Program",{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[47,53],"Other: Self-Myofascial Release",[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":32},"BEHAVIORAL","Exercise Program","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.",[43,49],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":32},"Self-Myofascial Release","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.",[49],[65],{"name":66,"affiliation":67,"role":68},"Sevtap GUNAY UÇURUM, Prof","Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation","STUDY_DIRECTOR",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":32,"email":74},"Sümena HAREKET KARAKAYA, PT","CONTACT","+905397264665","SumenaHareket4@gmail.com",{"name":76,"role":72,"phone":77,"phoneExt":32,"email":78},"Müge KIRMIZI, PhD","+905056013348","mugekirmizi1@gmail.com",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":32,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Bakırçay University Çiğli Regional Education Hospital","RECRUITING","Izmir","İzmir","TR-35620","Turkey (Türkiye)",{"type":88,"coordinates":89},"Point",[90,91],27.13838,38.41273,{"lat":91,"lon":90},[94],{"name":95,"role":72,"phone":96,"phoneExt":32,"email":97},"Elif Umay ALTAŞ, MD","+905053076622","elifumayaslan@hotmail.com",{"type":99,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Sümena Hareket","Physiotherapist, MSc student",[103],{"name":104,"class":6},"Cigli Regional Training Hospital","100624844",false,"NCT07414914","Self-Myofascial Release Plus Exercise Versus Exercise Alone in Type 2 Diabetes","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","Inclusion Criteria:\n\n* Individuals aged 30 to 65 years\n* Diagnosed with type 2 diabetes mellitus for at least 1 year\n* Controlled type 2 diabetes mellitus\n* Able to ambulate independently without assistive devices\n\nExclusion Criteria:\n\n* Severe pes planus or pes cavus defined by the Foot Posture Index-6 (FPI-6) (score ≥ +10 or ≤ -5)\n* History of plantar fasciitis\n* Plantar fascia ulceration\n* Peripheral neuropathy\n* Diagnosed peripheral vascular disease\n* History of lower extremity surgery or fracture during last year\n* Rheumatologic or connective tissue disorders affecting soft tissue properties\n* Neurological or diagnosed cognitive disorders\n* Pregnancy\n* Other types of diabetes mellitus\n* Obesity (BMI \\> 30 kg\u002Fm²)\n* Serious cardiopulmonary disorders, including heart failure, history of myocardial infarction, or severe chronic obstructive pulmonary disease or asthma","FEMALE","30 Years","65 Years",{"count":115,"type":116},40,"ESTIMATED","INTERVENTIONAL",[119],"NA","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.",[122],"Type 2 Diabetes",[124,125,126,127,128],"Exercise therapy","Self-myofascial release","Physical performance","Foot function","Plantar fascia","2026-02-11",{"date":131,"type":132},"2026-02-17","ACTUAL",{"date":134,"type":132},"2025-11-03",{"date":136,"type":116},"2026-05-04",{"name":5,"class":6},1]