[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616628":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":39,"locations":29,"responsibleParty":49,"collaborators":29,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":29,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":29,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":72,"whyStopped":29,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":29},{"fullName":5,"class":6},"Lahore University of Biological and Applied Sciences","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A( Vibration Therapy + Conventional Physical Therapy)","EXPERIMENTAL","Participants allocated to this group will receive vibration therapy in addition to conventional physical therapy. Localized vibration will be applied to the calf muscles using a low-voltage vibration device for 10 minutes during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen comprising a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down.",[13,14],"Other: Vibration","Behavioral: Conventional Physical Therapy",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B (Near-Infrared Light + Conventional Physical Therapy)","Participants allocated to this group will receive near-infrared (NIR) light therapy in addition to conventional physiotherapy. Near-infrared light will be applied to the lower limbs for 10 minutes during supervised rehabilitation sessions using a standardized therapeutic device. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down.",[19,14],"Other: Near-Infrared Light Therapy",{"label":21,"type":10,"description":22,"interventionNames":23},"Group C ( (Infrared light + Vibration and Conventional Therapy)","Participants allocated to this group will receive combined near-infrared (NIR) light therapy and vibration therapy in addition to conventional physiotherapy. Near-infrared light therapy will be applied to the lower limbs for 10 minutes using a standardized therapeutic device, followed by localized vibration therapy applied to the calf muscles for 10 minutes using a low-voltage vibration device during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down.",[19,13,14],[25,30,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Near-Infrared Light Therapy","The Near-infrared light therapy will be applied under the supervision of a qualified physiotherapist. Near-infrared light therapy involves the application of infrared lamps to the lower limbs to improve blood flow, reduce inflammation, and modulate neural activity associated with Restless Leg Syndrome symptoms. Participants in this group will receive NIR therapy for 10 minutes per session as part of the combined intervention. The intervention will be delivered three times per week for a total duration of 4 weeks.",[16,21],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Vibration","Vibration therapy will be delivered using a low-voltage vibration device applied to the calf muscles. The therapy is intended to stimulate sensory receptors, improve neuromuscular function, and reduce symptom severity. Participants will receive vibration therapy for 10 minutes per session. The intervention will be delivered three times per week for a total duration of 4 weeks.",[9,21],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"BEHAVIORAL","Conventional Physical Therapy","The stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions.",[9,16,21],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":29,"email":44},"Ainon Saleem","CONTACT","+923208438852","ainonsaleem246@gmail.com",{"name":46,"role":42,"phone":47,"phoneExt":29,"email":48},"Salwa Atta","+923084579229","salwa.atta@ubas.edu.pk",{"type":50,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100616628","combined-effects-of-near-infrared-light-and-vibration-on-diabetic-patients-with-restless-leg-syndrome-100616628",false,"NCT07308080","Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome","Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptoms Severity in Diabetic Patients With Restless Leg Syndrome","Inclusion Criteria:\n\nPatients of age 50-65 years Both male and female patients with Type II diabetes Patients with a diagnosis of diabetes at least 6 months ago RLS (score of 11+ on the RLS scale) Patients meeting the four key RLS diagnosis criteria will be included in the study.\n\nCriterion is: Urge to move due to uncomfortable leg sensations, symptoms worsening at rest, symptoms relief with movement ,greater symptom severity in the evening or at night.\n\nWillingness to provide informed consent .\n\nExclusion Criteria:\n\nPatients using analgesics, psychiatric, or neurological medications. Patients with any malignancies, neurological, skeletal, or vascular disorders History of drug abuse. Ongoing RLS treatments (e.g. vibration therapy, massage). Severe cognitive impairment. Pregnancy or lactation. Conditions contraindicating NIR or vibration therapy","ALL","50 Years","65 Years",{"count":62,"type":63},42,"ESTIMATED","INTERVENTIONAL",[66],"NA","This Randomized Clinical Trial, titled \"Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptom Severity in Diabetic Patients with Restless Leg Syndrome,\" aims to evaluate a non-pharmacological treatment for Restless Leg Syndrome (RLS) in diabetic patients. RLS is a neurological disorder causing an irresistible urge to move the legs, and its co-occurrence with diabetes significantly worsens symptoms, pain, and sleep quality. While both Near-Infrared (NIR) light therapy and vibration therapy have individually shown benefits, this study will investigate the potential synergistic effects of combining them. 42 diabetic patients with RLS (aged 50-65) will be randomly assigned to one of three groups for four weeks (3 sessions\u002Fweek): Group A (Vibration + Conventional Stretching), Group B (NIR Light + Conventional Stretching), and Group C (Combined Vibration and NIR Light + Conventional Stretching). Outcomes will be measured at baseline, 4 weeks, and 6 weeks using the International Restless Leg Syndrome Rating Scale (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the Numeric Pain Rating Scale (NPRS). This research explores the synergistic effects of near-infrared light and vibration therapy on Restless Leg Syndrome (RLS) symptoms in diabetic patients, aiming to alleviate symptoms, improve sleep quality, and enhance overall well-being.",[69],"Restless Leg Syndrome (RLS)",[71],"RLS, Diabetic patient, Near-Infrared Light, Vibration, Pain, Sleep Quality","NOT_YET_RECRUITING","2025-12-15",{"date":75,"type":76},"2025-12-29","ACTUAL",{"date":78,"type":63},"2025-12-14",{"date":80,"type":63},"2026-05",{"name":5,"class":6}]