Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
NCT07272239

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

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

1
2
3
+1

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

Loading map...

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