NCT07272239 Effects of tVNS and mCIMT in Chronic Stroke
| NCT ID | NCT07272239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riphah International University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2026-05-05 |
Trial Parameters
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Brief Summary
Stroke is a leading cause of death and disability worldwide, resulting in significant physical and cognitive impairments. Arm weakness is most common after stroke and its treatment is recognized as an area of considerable need. The functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb have a profound impact on their quality of life. Current treatment for arm weakness typically comprises intensive, task-specific and repetitive rehabilitative interventions. Transcutaneous auricular vagus nerve stimulation (tVNS) is a novel noninvasive treatment for stroke that directly stimulates the peripheral auricular branch of the vagus nerve. This study determines the effects of Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy on Motor Function, Cognition, and Quality of life in chronic stroke patients. This randomized clinical trial will be conducted at IIMCT Railway General Hospital and Al-firdous physiotherapy clinic over a duration of six months. The sample size will consist of 50 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique, which will further be randomized through online randomization tool. 25 Participants will be assigned to Group A receiving tVNS and mCIMT with routine physical therapy and 25 to Group B receiving mCIMT with routine physical therapy . Data will be collected using various assessment tools, including Fugl-Meyer Assessment-UE (FM-UE), and Nine-hole peg test (NHPT) to assess Motor function. Stroke Impact Scale (SIS) to assess QOL, Montreal cognitive assessment (MoCA) to assess cognition, and Modified Ashworth scale to assess spasticity. All participants will receive intervention 3 days a week on alternative days for 8 weeks. Pre-intervention assessments will be conducted for both groups. The effects of the interventions will be measured at pre-treatment, 4th week, and post-intervention. Data analysis will be performed by using SPSS 26 software. Key words: Modified Constraint Induced movement Therapy, Motor function, Rehabilitation, Stroke, Transcutaneous Vagus nerve stimulation, Upper extremity.
Eligibility Criteria
Inclusion Criteria: * Both male and female patients are included in the study. * Left sided ischemic stroke patients. * Patients with chronic, moderate-severe upper limb hemiparesis (\>6 months-2 years) * Stable participants having a stroke severity score \> 6 on National Institute of Health Stroke Scale (NIHSS). * Montreal Cognitive Assessment (MoCA) score ≥26. Exclusion Criteria: * Participants who show the symptoms of global or receptive aphasia. * Participants who have a history of significant neurological or psychiatric disorders, other than stroke, that could interfere with upper limb motor or sensory recovery. * Modified Ashworth scale score ≥ 3 of the affected upper extremity. * Patients who are not able to sit with or without support. * Patients with severe apraxia, somatosensory problems. * Resting heart rate (\< 50 beats/min). * Participants who are currently participating in another clinical trial or research study.
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