StrokeNCT07272239
Effects of tVNS and mCIMT in Chronic Stroke
A study testing Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy with Routine Physical Therapy in people with Stroke and Cerebrovascular Accident, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy with Routine Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPakistan
- Study dates
- 25 Nov 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Al- firdous physiotherapy clinic
Rawalpindi, Punjab Province, 46000
- Recruiting
IIMCT- Railway General Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Combined Effects of Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy on Upper Extremity Function, Cognition and Quality of Life in Individual With Chronic Stroke
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.
Read the detailed description
Stroke is the third leading cause of death and the leading cause of adult disability. Patients with stroke suffer from neuromuscular disabilities, including impairments in motor control. Stroke survivors with hemiplegia exhibit more upper-limb (UL) than lower-limb (LL) disability. Dysfunction from upper extremity hemi paresis impairs performance of many daily activities such as dressing, bathing, self-care and writing, thus reducing functional independence. Only 5% of adults regain full arm function after stroke, and 20% regain no functional use. Restoration of full function to the stroke affected upper extremity is a major problem in rehabilitation. Hence alternative strategies are needed to reduce the long-term disabilities and functional impairment resulting from upper extremity hemi paresis.
The severity of the neurological deficits and early patterns of improvement are the two best predictors of recovery from impairments. Patients are generally thought to experience less UL motor recovery than LL motor recovery; however, this clinical belief is typically based on disability assessments rather than tests of specific motor deficits of UL and LL. Since UL function needs finer motor control than LL function, this might explain the common scenario of less variation between impairment and disability. There are several promising treatment options available for upper-limb stroke rehabilitation, such as cross education, constraint-induced movement therapy, virtual reality therapy, functional electrical stimulation, robotic therapy, anodal transcranial direct current stimulation, and motor imagery.
Unfortunately, VNS necessitates a costly, invasive surgical procedure. In the last years, transcutaneous VNS (ta-VNS) has been proposed as a noninvasive and patient friendly method to stimulate the vagus nerve, through the skin, by delivering weak electric current to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. Such stimulation activates the auricular branch of the vagus nerve and, via this pathway, the nuclei of the nerve located in the brainstem, enhancing brain GABA and Noradrenaline levels, which plays a pivotal role in brain plasticity. These connections regulate the release of neuromodulators, including acetylcholine, norepinephrine, serotonin, and brain-derived neurotrophic factors, which promote cortical plasticity.
The rationale for this study lies in its potential to uncover synergistic benefits from combining these two therapies, ultimately aiming to enhance functional recovery and cognitive engagement among chronic stroke survivors, thereby improving their daily lives and reintegration into society. The exploration of effective rehabilitation strategies is crucial, as traditional therapies frequently provide limited benefits for chronic stroke patients, particularly concerning upper extremity function. This research investigates the combined effects of ta-VNS and Modified CIMT on these patients, aiming to enhance motor recovery and cognitive engagement. The findings may inform future therapeutic approaches and offer hope for improved independence and well-being among individuals affected by chronic stroke.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- Transcutaneous Vagus Nerve Stimulation, Modified Constraint Induced Movement Therapy with Routine Physical Therapy
- Keywords
- Vagus Nerve Stimulation, Motor Function, Modified Constraint Induced Movement Therapy, Upper Limb Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationDevice
Each treatment session will last one hour, conducted three times per week on alternate days for eight weeks. The session will begin with 30 minutes of routine physical therapy, which will include active and active-assisted range of motion exercises, strengthening and coordination activities, and functional task training for the upper extremity. The following 30 minutes will include concurrent tVNS and mCIMT. tVNS will be administered through surface electrodes placed on the auricular region (tragus or cymba conchae) of the ear, with stimulation parameters set at a frequency of 25 Hz, pulse width of 250 μs, and intensity adjusted to a comfortable tingling level below the pain threshold. During this period, participants will perform task-oriented activities of the affected upper limb through functional tasks such as reaching, grasping, and object manipulation. Shaping techniques will be used to progressively increase task difficulty, and a soft mitt applied to the unaffected hand.
Modified Constraint Induced Movement Therapy with Routine Physical TherapyOther
Participants will also receive session lasting for one hour, with 30 minutes devoted to routine physical therapy followed by 30 minutes of mCIMT. The routine physical therapy component will include range of motion exercises, stretching, strengthening, and functional movement training similar to Group A to ensure treatment uniformity. The 30-minute mCIMT intervention will consist of intensive, task-specific practice of the affected upper limb under therapist supervision, focusing on goal-oriented functional tasks and repetitive training to enhance motor performance. A shaping approach will be used to progressively increase task complexity based on individual capability, and a soft constraint applied to the unaffected limb during the session.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy with Routine Physical Therapy Receives: Device: Transcutaneous Vagus Nerve Stimulation; Other: Modified Constraint Induced Movement Therapy with Routine Physical Therapy |
| Group B | Experimental | Modified Constraint Induced Movement Therapy with Routine Physical Therapy Receives: Other: Modified Constraint Induced Movement Therapy with Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl- Meyer Assessment- UE (FM-UE)
The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is a reliable and valid tool for evaluating upper limb function in stroke patients. Comprising 33 items, it assesses motor function, sensory function, and joint mobility. The FMA-UE demonstrates excellent intra-rater (ICC > 0.90) and inter-rater reliability (median agreement ~77%). It correlates well with other measures, showing strong construct validity and responsiveness, making it essential for tracking recovery in rehabilitation settings.
Measured: Assessment will be done at baseline, 4th and 8th week of intervention
Nine- hole peg test (NHPT)
The Nine-Hole Peg Test (NHPT) is a widely used assessment tool for measuring manual dexterity and fine motor skills, particularly in clinical populations such as stroke and multiple sclerosis patients. The test involves placing and removing nine pegs from a pegboard as quickly as possible, with the time taken recorded in seconds. Reliability is strong, with intraclass correlation coefficients (ICCs) ranging from 0.91 to 0.94 for individuals with stroke and 0.49 to 0.66 for healthy adults, indicating good relative reliability. Validity is supported by its ability to discriminate between varying levels of impairment and its correlation with other dexterity measures, confirming its effectiveness in clinical settings.
Measured: Assessment will be done at baseline, 4th and 8th week of intervention
Montreal cognitive assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely utilized screening tool developed by Dr. Ziad Nasreddine in 1996 to detect cognitive impairment, particularly mild cognitive impairment (MCI) and early Alzheimer's disease. The test takes about 10 minutes and evaluates multiple cognitive domains, including memory, attention, language, executive function, and visuospatial abilities. MoCA has shown high reliability (ICC = 0.92) and good internal consistency (Cronbach's alpha = 0.82). Its sensitivity for detecting MCI is 90%, with a specificity of 87% compared to the Mini-Mental State Examination (MMSE).
Measured: Assessment will be done at baseline, 4th and 8th week of intervention
Stroke impact scale (SIS)
The Stroke Impact Scale (SIS) is a patient-reported outcome measure designed to evaluate the effects of stroke on various aspects of life, including physical, emotional, and social domains. Developed by Duncan et al. in 1999, the SIS assesses eight dimensions: strength, hand function, mobility, activities of daily living, emotion, memory, communication, and social participation. The scale produces scores ranging from 0 to 100, with higher scores indicating better function. It has demonstrated excellent reliability (Cronbach's alpha = 0.83 to 0.95) and validity in predicting quality of life post-stroke.
Measured: Assessment will be done at baseline, 4th and 8th week of intervention
Secondary outcomes (1)
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a widely utilized tool for assessing spasticity, particularly in patients with neurological conditions such as stroke, cerebral palsy, and multiple sclerosis. Developed in 1987 by Bohannon and Smith, the MAS enhances the original Ashworth Scale by adding a category (1+) to improve sensitivity to lower levels of muscle tone. The scale ranges from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension), allowing clinicians to evaluate resistance during passive movement. The MAS demonstrates moderate to good interrater reliability, with coefficients ranging from 0.74 to 0.93, and strong intrarater reliability values between 0.84 and 0.95. Nevertheless, it shows good correlations with other measures of muscle resistance and electromyography (EMG) parameters, making the MAS a critical tool in both clinical practice and research for evaluating spasticity and guiding treatment interventions.
Measured: Assessment will be done at baseline, 4th and 8th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start25 Nov 2025
- Primary completion5 May 2026 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272239
- Sponsor's protocol ID
- REC/0270 Zara Mansha
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Page SJ, Sisto S, Levine P, McGrath RE. Efficacy of modified constraint-induced movement therapy in chronic stroke: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2004 Jan;85(1):14-8. doi: 10.1016/s0003-9993(03)00481-7.
PubMed 14970962Hays SA. Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Neurotherapeutics. 2016 Apr;13(2):382-94. doi: 10.1007/s13311-015-0417-z.
PubMed 26671658Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
PubMed 30217648Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
PubMed 26645257Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
PubMed 23954448
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy on Upper Extremity Function, Cognition and Quality of Life in Individual With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07272239
- Acronym / sponsor ID
- REC/0270 Zara Mansha
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- Vagus Nerve Stimulation, Motor Function, Modified Constraint Induced Movement Therapy, Upper Limb Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stroke is the third leading cause of death and the leading cause of adult disability. Patients with stroke suffer from neuromuscular disabilities, including impairments in motor control. Stroke survivors with hemiplegia exhibit more upper-limb (UL) than lower-limb (LL) disability. Dysfunction from upper extremity hemi paresis impairs performance of many daily activities such as dressing, bathing, self-care and writing, thus reducing functional independence. Only 5% of adults regain full arm function after stroke, and 20% regain no functional use. Restoration of full function to the stroke affected upper extremity is a major problem in rehabilitation. Hence alternative strategies are needed to reduce the long-term disabilities and functional impairment resulting from upper extremity hemi paresis.
The severity of the neurological deficits and early patterns of improvement are the two best predictors of recovery from impairments. Patients are generally thought to experience less UL motor recovery than LL motor recovery; however, this clinical belief is typically based on disability assessments rather than tests of specific motor deficits of UL and LL. Since UL function needs finer motor control than LL function, this might explain the common scenario of less variation between impairment and disability. There are several promising treatment options available for upper-limb stroke rehabilitation, such as cross education, constraint-induced movement therapy, virtual reality therapy, functional electrical stimulation, robotic therapy, anodal transcranial direct current stimulation, and motor imagery.
Unfortunately, VNS necessitates a costly, invasive surgical procedure. In the last years, transcutaneous VNS (ta-VNS) has been proposed as a noninvasive and patient friendly method to stimulate the vagus nerve, through the skin, by delivering weak electric current to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. Such stimulation activates the auricular branch of the vagus nerve and, via this pathway, the nuclei of the nerve located in the brainstem, enhancing brain GABA and Noradrenaline levels, which plays a pivotal role in brain plasticity. These connections regulate the release of neuromodulators, including acetylcholine, norepinephrine, serotonin, and brain-derived neurotrophic factors, which promote cortical plasticity.
The rationale for this study lies in its potential to uncover synergistic benefits from combining these two therapies, ultimately aiming to enhance functional recovery and cognitive engagement among chronic stroke survivors, thereby improving their daily lives and reintegration into society. The exploration of effective rehabilitation strategies is crucial, as traditional therapies frequently provide limited benefits for chronic stroke patients, particularly concerning upper extremity function. This research investigates the combined effects of ta-VNS and Modified CIMT on these patients, aiming to enhance motor recovery and cognitive engagement. The findings may inform future therapeutic approaches and offer hope for improved independence and well-being among individuals affected by chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Transcutaneous Vagus Nerve Stimulation, Other: Modified Constraint Induced Movement Therapy with Routine Physical TherapyTranscutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy with Routine Physical Therapy |
| Group B | Experimental | Other: Modified Constraint Induced Movement Therapy with Routine Physical TherapyModified Constraint Induced Movement Therapy with Routine Physical Therapy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Vagus Nerve StimulationEach treatment session will last one hour, conducted three times per week on alternate days for eight weeks. The session will begin with 30 minutes of routine physical therapy, which will include active and active-assisted range of motion exercises, strengthening and coordination activities, and functional task training for the upper extremity. The following 30 minutes will include concurrent tVNS and mCIMT. tVNS will be administered through surface electrodes placed on the auricular region (tragus or cymba conchae) of the ear, with stimulation parameters set at a frequency of 25 Hz, pulse width of 250 μs, and intensity adjusted to a comfortable tingling level below the pain threshold. During this period, participants will perform task-oriented activities of the affected upper limb through functional tasks such as reaching, grasping, and object manipulation. Shaping techniques will be used to progressively increase task difficulty, and a soft mitt applied to the unaffected hand. | Device | Group A |
| Modified Constraint Induced Movement Therapy with Routine Physical TherapyParticipants will also receive session lasting for one hour, with 30 minutes devoted to routine physical therapy followed by 30 minutes of mCIMT. The routine physical therapy component will include range of motion exercises, stretching, strengthening, and functional movement training similar to Group A to ensure treatment uniformity. The 30-minute mCIMT intervention will consist of intensive, task-specific practice of the affected upper limb under therapist supervision, focusing on goal-oriented functional tasks and repetitive training to enhance motor performance. A shaping approach will be used to progressively increase task complexity based on individual capability, and a soft constraint applied to the unaffected limb during the session. | Other | Group A, Group B |
Primary outcome
Fugl- Meyer Assessment- UE (FM-UE)
Time frame: Assessment will be done at baseline, 4th and 8th week of intervention
The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is a reliable and valid tool for evaluating upper limb function in stroke patients. Comprising 33 items, it assesses motor function, sensory function, and joint mobility. The FMA-UE demonstrates excellent intra-rater (ICC > 0.90) and inter-rater reliability (median agreement ~77%). It correlates well with other measures, showing strong construct validity and responsiveness, making it essential for tracking recovery in rehabilitation settings.
Nine- hole peg test (NHPT)
Time frame: Assessment will be done at baseline, 4th and 8th week of intervention
The Nine-Hole Peg Test (NHPT) is a widely used assessment tool for measuring manual dexterity and fine motor skills, particularly in clinical populations such as stroke and multiple sclerosis patients. The test involves placing and removing nine pegs from a pegboard as quickly as possible, with the time taken recorded in seconds. Reliability is strong, with intraclass correlation coefficients (ICCs) ranging from 0.91 to 0.94 for individuals with stroke and 0.49 to 0.66 for healthy adults, indicating good relative reliability. Validity is supported by its ability to discriminate between varying levels of impairment and its correlation with other dexterity measures, confirming its effectiveness in clinical settings.
Montreal cognitive assessment (MoCA)
Time frame: Assessment will be done at baseline, 4th and 8th week of intervention
The Montreal Cognitive Assessment (MoCA) is a widely utilized screening tool developed by Dr. Ziad Nasreddine in 1996 to detect cognitive impairment, particularly mild cognitive impairment (MCI) and early Alzheimer's disease. The test takes about 10 minutes and evaluates multiple cognitive domains, including memory, attention, language, executive function, and visuospatial abilities. MoCA has shown high reliability (ICC = 0.92) and good internal consistency (Cronbach's alpha = 0.82). Its sensitivity for detecting MCI is 90%, with a specificity of 87% compared to the Mini-Mental State Examination (MMSE).
Stroke impact scale (SIS)
Time frame: Assessment will be done at baseline, 4th and 8th week of intervention
The Stroke Impact Scale (SIS) is a patient-reported outcome measure designed to evaluate the effects of stroke on various aspects of life, including physical, emotional, and social domains. Developed by Duncan et al. in 1999, the SIS assesses eight dimensions: strength, hand function, mobility, activities of daily living, emotion, memory, communication, and social participation. The scale produces scores ranging from 0 to 100, with higher scores indicating better function. It has demonstrated excellent reliability (Cronbach's alpha = 0.83 to 0.95) and validity in predicting quality of life post-stroke.
1 secondary outcome
Modified Ashworth Scale (MAS)
Time frame: Assessment will be done at baseline, 4th and 8th week of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 14970962Page SJ, Sisto S, Levine P, McGrath RE. Efficacy of modified constraint-induced movement therapy in chronic stroke: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2004 Jan;85(1):14-8. doi: 10.1016/s0003-9993(03)00481-7.
- Background: PubMed 26671658Hays SA. Enhancing Rehabilitative Therapies with Vagus Nerve Stimulation. Neurotherapeutics. 2016 Apr;13(2):382-94. doi: 10.1007/s13311-015-0417-z.
- Background: PubMed 30217648Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.
- Background: PubMed 26645257Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
- Background: PubMed 23954448Khodaparast N, Hays SA, Sloan AM, Hulsey DR, Ruiz A, Pantoja M, Rennaker RL 2nd, Kilgard MP. Vagus nerve stimulation during rehabilitative training improves forelimb strength following ischemic stroke. Neurobiol Dis. 2013 Dec;60:80-8. doi: 10.1016/j.nbd.2013.08.002. Epub 2013 Aug 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aruba Saeed, Phd principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy with Routine Physical Therapy in people with Stroke and Cerebrovascular Accident, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zara Mansha, Ms-Nmpt (+923247502192, zaramansha09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl- Meyer Assessment- UE (FM-UE) (time frame: Assessment will be done at baseline, 4th and 8th week of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272239, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.