[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628920":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":17,"armGroups":41,"interventions":64,"overallOfficials":80,"centralContacts":85,"locations":91,"responsibleParty":110,"collaborators":17,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":17,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":94,"whyStopped":17,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of Baghdad","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":18},[9,13],{"measure":10,"description":11,"timeFrame":12},"Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)","Assesses motor recovery of the affected upper limb following stroke, including voluntary movement, coordination, and reflex activity using a standardized stroke-specific motor scale. Scores range from 0 to 66, with higher scores indicating better motor recovery and motor performance.","Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up.",{"measure":14,"description":15,"timeFrame":16},"Functional Use of Affected Limb (Functional Test of Upper Limb Hemiplegia - Hong Kong, FTHUE-HK)","Evaluates functional use of the affected upper limb in individuals with hemiplegia through hierarchical task performance. Scores range from Level 1 (no active movement) to Level 7 (advanced functional hand use), with higher levels indicating greater functional recovery.","Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up",null,[19,23,26,30],{"measure":20,"description":21,"timeFrame":22},"Activities of Daily Living (Katz Index of Independence in ADL)","Measures the participant's ability to independently perform six basic self-care activities including bathing, dressing, toileting, transferring, continence, and feeding. Scores range from 0 to 6, with higher scores indicating greater independence in activities of daily living.","Baseline, 4 weeks, post-intervention, 3-month follow-up",{"measure":24,"description":25,"timeFrame":22},"Upper Limb Spasticity (Modified Ashworth Scale, MAS)","Assesses muscle spasticity in the affected upper limb by grading resistance during passive soft-tissue stretching. Scores range from 0 to 4, where higher scores indicate increased muscle tone and greater spasticity.",{"measure":27,"description":28,"timeFrame":29},"Cognitive Screening (Six-Item Cognitive Impairment Test, 6CIT)","A brief screening tool used to assess cognitive status prior to study participation, including orientation, memory, and attention. Scores range from 0 to 28, with higher scores indicating greater cognitive impairment.","Baseline",{"measure":31,"description":32,"timeFrame":29},"Visual Acuity (Snellen Chart)","Evaluates visual acuity to ensure participants can adequately perform mirror-based visual feedback during therapy. Visual acuity is measured using the standard Snellen fraction (e.g., 6\u002F6 to 6\u002F60), where better vision corresponds to higher visual acuity.",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":17,"timePerspective":17,"maskingInfo":38},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of four parallel groups: conventional rehabilitation, mirror therapy, soft robotic glove training, or a combination of mirror therapy and soft robotic glove intervention for upper limb rehabilitation after stroke.","TREATMENT",{"masking":39,"maskingDescription":17,"whoMasked":17},"NONE","Stroke is one of the leading causes of long-term disability worldwide and commonly results in upper limb motor impairment. Recovery of hand function is essential for improving independence in activities of daily living. However, rehabilitation of the affected upper limb remains a major challenge in stroke management.\n\nMirror therapy is a rehabilitation technique that provides visual feedback by reflecting movements of the unaffected limb in a mirror, creating the illusion that the affected limb is moving normally. This approach is believed to promote cortical reorganization and enhance motor recovery. In recent years, robotic-assisted rehabilitation devices, including soft robotic gloves, have been developed to provide repetitive, task-specific training and facilitate motor relearning.\n\nSoft robotic gloves are wearable assistive devices designed to support hand movements and enable repetitive practice of grasping and releasing tasks. These devices provide controlled assistance during rehabilitation exercises and may enhance the intensity and effectiveness of therapy.\n\nThis study is designed as a randomized controlled trial to evaluate the effectiveness of combining mirror therapy with soft robotic glove training in improving hand function among patients with post-stroke hemiplegia. Eligible participants will be randomly assigned to intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.\n\nThe intervention program will be delivered over a structured rehabilitation period, and clinical assessments will be conducted at baseline and after completion of the intervention. Outcome measures will focus on upper limb motor recovery, hand function performance, and functional independence.\n\nThe results of this study are expected to provide evidence regarding the effectiveness of integrating mirror therapy with robotic-assisted rehabilitation approaches for improving upper limb recovery after stroke. This may support the development of more effective rehabilitation protocols for patients with post-stroke hemiplegia.",[42,48,54,59],{"label":43,"type":44,"description":45,"interventionNames":46},"Conventional Rehabilitation","ACTIVE_COMPARATOR","Participants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation",[47],"Other: Conventional Rehabilitation",{"label":49,"type":50,"description":51,"interventionNames":52},"Mirror Therapy","EXPERIMENTAL","Participants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke.",[53],"Other: Mirror Therapy",{"label":55,"type":50,"description":56,"interventionNames":57},"Soft Robotic Glove Training","Participants perform upper limb training using a soft robotic glove device to assist hand movement and improve motor recovery after stroke.",[58],"Device: Soft Robotic Glove",{"label":60,"type":50,"description":61,"interventionNames":62},"Mirror Therapy plus Soft Robotic Glove","Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training to enhance upper limb motor recovery after stroke.",[63],"Combination Product: Mirror Therapy plus Soft Robotic Glove",[65,68,71,76],{"type":6,"name":43,"description":66,"armGroupLabels":67,"otherNames":17},"Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke",[43],{"type":6,"name":49,"description":69,"armGroupLabels":70,"otherNames":17},"A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke.",[49],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":17},"DEVICE","Soft Robotic Glove","A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke",[55],{"type":77,"name":60,"description":78,"armGroupLabels":79,"otherNames":17},"COMBINATION_PRODUCT","Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training",[60],[81],{"name":82,"affiliation":83,"role":84},"Wafaa Hattab, PhD","University of Baghdad, College of Nursing","PRINCIPAL_INVESTIGATOR",[86],{"name":87,"role":88,"phone":89,"phoneExt":17,"email":90},"Mohammed Hindi Jaryan, PhD Candidate","CONTACT","+9647808046480","mhmdalwtyfy683@gmail.com",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":17,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Rehabilitation and Neurology Outpatient Unit","RECRUITING","Baghdad","Babylon","Iraq","IQ",{"type":100,"coordinates":101},"Point",[102,103],44.40088,33.34058,{"lat":103,"lon":102},[106,107,109],{"name":87,"role":88,"phone":89,"phoneExt":17,"email":90},{"name":108,"role":88,"phone":89,"phoneExt":17,"email":90},"Wafaa Jaryan, PhD",{"name":82,"role":84,"phone":17,"phoneExt":17,"email":17},{"type":84,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Mohammed Hindi Jaryan","PhD Candidate","100628920","combined-mirror-therapy-and-soft-robotic-glove-for-hand-recovery-after-stroke-100628920",false,"NCT07467915","Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke","Effect of Combining Mirror Therapy With Soft Robotic Glove on Hand Function Recovery in Post-Stroke Hemiplegic Patients: A Randomized Controlled Trial","MT-SRG","Inclusion Criteria:\n\nAdults aged 18-70 years with first-ever ischemic or hemorrhagic stroke confirmed by imaging (CT or MRI)\n\nModerate upper limb motor impairment (Fugl-Meyer Assessment Upper Extremity \\[FMA-UE\\] score 20-50)\n\nAbility to follow simple instructions (Six-Item Cognitive Impairment Test, 6CIT)\n\nAbility to sit independently for at least 30 minutes\n\nMedically stable and cleared to participate in rehabilitation interventions\n\nWillingness to provide informed consent and adhere to the study protocol\n\nExclusion Criteria:\n\nSevere upper limb spasticity (Modified Ashworth Scale ≥ 3)\n\nCognitive or psychiatric disorders interfering with participation\n\nOther neurological or musculoskeletal conditions affecting upper limb function (e.g., Parkinson's disease, multiple sclerosis, fractures)\n\nPrior exposure to intensive Mirror Therapy or Soft Robotic Gloves\n\nVisual impairment that cannot be corrected with glasses or contact lenses\n\nUncontrolled cardiovascular or other medical conditions that would prevent safe participation","ALL","18 Years","70 Years",{"count":125,"type":126},104,"ESTIMATED","INTERVENTIONAL",[129],"NA","Post-stroke hemiplegia frequently results in impaired upper limb function, which significantly affects independence and quality of life. Various rehabilitation approaches have been developed to improve motor recovery, including mirror therapy and robotic-assisted training. Mirror therapy uses visual feedback to stimulate neural plasticity and enhance motor recovery, while soft robotic gloves assist repetitive hand movements and facilitate functional training.\n\nThis randomized controlled trial aims to investigate the effect of combining mirror therapy with a soft robotic glove on hand function recovery in patients with post-stroke hemiplegia. Participants will be randomly assigned to different intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.\n\nThe primary outcome will assess improvement in upper limb motor function using validated clinical assessment tools. Secondary outcomes will evaluate functional hand performance and activities of daily living. The findings of this study may contribute to improving rehabilitation strategies for stroke survivors and provide evidence for integrating innovative rehabilitation technologies into clinical practice.",[132,133,134],"Stroke","Hemiplegia","Upper Limb Motor Impairment",[49,73,136,137,138,139],"Stroke Rehabilitation","Hand Function Recovery","Upper Limb Rehabilitation","Post-Stroke Hemiplegia","2026-05-08",{"date":142,"type":143},"2026-05-13","ACTUAL",{"date":145,"type":143},"2026-04-08",{"date":147,"type":126},"2026-12-17",{"name":5,"class":6},1]