Actively Recruiting
Effects of tVNS and mCIMT in Chronic Stroke
Led by Riphah International University · Updated on 2025-12-09
50
Participants Needed
2
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of tVNS and mCIMT in Chronic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients are eligible.
- Patients must have left sided ischemic stroke.
- Participants should have chronic, moderate to severe upper limb hemiparesis lasting more than 6 months up to 2 years.
- Stable stroke patients with a National Institute of Health Stroke Scale (NIHSS) score greater than 6.
- Montreal Cognitive Assessment (MoCA) score of 26 or higher.
You will not qualify if you...
- Participants with symptoms of global or receptive aphasia.
- History of significant neurological or psychiatric disorders other than stroke that affect upper limb recovery.
- Modified Ashworth scale score of 3 or higher in the affected upper limb.
- Patients unable to sit with or without support.
- Patients with severe apraxia or somatosensory problems.
- Resting heart rate below 50 beats per minute.
- Participants currently enrolled in another clinical trial or research study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Al- firdous physiotherapy clinic
Rawalpindi, Punjab Province, Pakistan, 46000
Actively Recruiting
2
IIMCT- Railway General Hospital
Rawalpindi, Punjab Province, Pakistan, 46000
Actively Recruiting
Research Team
Z
Zara Mansha, Ms-Nmpt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here