[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657570":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":32,"interventions":43,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":56,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":23,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":23,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":23},{"fullName":5,"class":6},"University of Lahore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Berg Balance Scale (BBS)","The Berg Balance Scale (BBS) is a commonly used clinical scale for assessing static and dynamic balance in sitting and standing. It consists of 14 functional balance items that assess the ability to maintain positions and perform postural adjustments during functional movements. Each item is scored from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance. The BBS has demonstrated high reliability and good validity for assessing balance.","Baseline and immediately after 4 weeks of intervention",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Short Form-12 Health Survey (SF-12)","Quality of Life SF12 Questionnaire :\n\nThe SF12 questionnaire used to assess the quality of life. It is a health related quality of life questionnaire including 12 questions.It has eight main which are some up into see physical and mental health. It has a scoring range from 0 to hundred for both physical as well as mental health.",{"measure":18,"description":19,"timeFrame":12},"SINBAD Scoring System:","Foot condition severity will be assessed using the SINBAD classification system, which evaluates site, ischemia, bacterial infection, area, and depth.\n\nThe SINBAD classification system will be used to assess the clinical status and severity of diabetic foot ulcer.",{"measure":21,"description":22,"timeFrame":12},"Toronto Clinical Neuropathy Score (TCNS)","It is used to assess the severity of the diabetic foot neuropathy. It assess the sensory test, reflexes as well as symptoms. It scoring shows from 0 to 5 shows no diabetic peripheral neuropathy, 6 to 8 shows mild diabetic peripheral neuropathy, 9 to 11 shows moderate diabetic peripheral neuropathy and 12 to 19 shows severe diabetic peripheral neuropathy. It has a good reliability of 0.83 to 0.87. It also has a good validity of 0.713.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"SINGLE",[31],"OUTCOMES_ASSESSOR",[33,38],{"label":34,"type":35,"description":23,"interventionNames":36},"Tibial Nerve Mobilization","EXPERIMENTAL",[37],"Behavioral: Tibial Nerve Mobilization",{"label":39,"type":40,"description":23,"interventionNames":41},"Multisensory Exercises","ACTIVE_COMPARATOR",[42],"Behavioral: Multisensory exercises",[44,52],{"type":45,"name":34,"description":46,"armGroupLabels":47,"otherNames":48},"BEHAVIORAL","Participants will receive supervised physical therapy targeting neuropathic symptoms, healing , mobility issues, quality of life associated with diabetic foot ulcers early grades. The regimen consists of 35 to 45 -minute sessions, 3 days per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy, including Transcutaneous Electrical Nerve Stimulation (TENS).Pulse Duration: 150 µs and 80 Hz frequency for effective nerve stimulation and pain relief, active and passive ankle range-of-motion exercises, dosriflexion and plantar flexion, inversion eversion ,with 10 repetitions for10 minutes and foot care education which includes moisturizing and hygiene advice and foot wear guidance . This is followed by a 20-minute main intervention of tibial nerve mobilization, which utilizes a combination of remote sliders, local sliders, and tensioners (end-range neural loading) to promote neural sliding and elongation while minimizing mechanical stress.",[34],[49,50,51],"Nerve flossing","Neural Mobilization","Neural Gliding",{"type":45,"name":53,"description":54,"armGroupLabels":55,"otherNames":23},"Multisensory exercises","Participants will receive a multisensory exercises training program alongside conventional physical therapy. The regimen consists of 35-to 45 minute sessions, 3 times per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy (TENS, ankle range of motion, and foot care). Exercises include a structured warm-up, ankle flexion ,extension, inversion , eversion , short walk ,calf and hamstring stretching 10 repetitions Followed by 20 minutes of multisensory training.Visual system activities (e.g., eye tracking ,follow moving object , circular eye movements and visual-motor coordination. Somatosensory exercises (walking on varying surfaces such as flat surface , mattresses and foam rubber). Proprioception\u002Fvestibular stimulation (e.g., unipedal stances, tandem stance , tandem walking( heel to toe walk), walking variations such as backward , forward, multidirectional walking, and cognitive dual-task obstacle navigation eg. functional mobility training .",[39],{"type":57,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100657570","tibial-nerve-mobilization-versus-multisensory-exercises-in-patients-with-diabetic-foot-ulcer-100657570",false,"NCT07841730","Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer","Inclusion Criteria:\n\n* Adults aged 55-75 years\n* Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.\n* Both male and female participants.\n* Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.\n* Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg\u002Fdl or Random Blood Glucose ≥ 200 mg\u002Fdl.\n* Patient with healed ulcer or in last stage of healing duration \\>1 to 2 weeks\n* Absence of active infection.\n* No cognitive impairments that would affect participation.\n* Diabetes duration of less than 10 years.\n* Able to perform the exercises and participate in physical therapy sessions.\n* No history of amputation above the metatarsophalangeal joint.\n\nExclusion Criteria:\n\n* Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.\n* Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.\n* Recent fractures, or trauma leading to nerve injuries in the last year.\n* Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.\n* Visual impairments or cognitive disorders that could affect participation.\n* History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.\n* Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.\n* Pregnancy or unwillingness to participate.","ALL","55 Years","75 Years",{"count":68,"type":69},38,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.",[75],"Diabetic Foot",[77,39,78,79],"Tibial nerve mobilization","Diabetic foot ulcer","Diabetic Peripheral neuropathy","NOT_YET_RECRUITING","2026-09-19",{"date":83,"type":84},"2026-09-25","ACTUAL",{"date":86,"type":69},"2026-09",{"date":88,"type":69},"2027-05",{"name":5,"class":6}]