Subacute StrokeNCT06927206
Segmental Vibrator With NMES on Lower Limb Function in Subacute Stroke
A study testing Experimental Group A: Segmental vibrator only on dorsiflexor and Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors in people with Subacute Stroke and Ischemic Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is one of the world's leading causes of death and disability. It can cause a variety of motor disorders, such as apraxia, sensory deficits, abnormal muscle tone, inadequate weight transfer, lack of fine motor skills, incoordination, and balance deficit. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Subacute Stroke, Ischemic Stroke
- What is being tested?
- Experimental Group A: Segmental vibrator only on dorsiflexor and Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2025to 30 Sep 2025
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both male and female patients were included in the study.
- The age range of participants was between 45 and 60 years.
- Participants that were diagnosed with ischemic stroke patient.
- Participants had experienced sub-acute ischemic stroke, specifically 15 days to 12 weeks post-stroke.
- Montreal Cognitive Assessment scores falling within the range of 18-24 were necessary.
- Modified Ashworth scale scores had to be less than +1
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- National Institutes of Health Stroke Scale (NIHSS) score falling within the range of 1 to 15 were necessary.
- Participants feel no pain from the vibrator.
- It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.
Who cannot join
- People who had a history of serious neurological or mental conditions that would have impeded lower limb motor recovery-aside from stroke-were not included.
- Individuals with severe arthritis or joint injuries, among other illnesses that would have interfered with treatment or evaluations, were not allowed to participate.
- Individuals who had significant hearing or vision impairments that would have hampered treatment or evaluations were not included.
- Individuals undergoing anti-spatial therapy or other clinical trials, those with bilateral brain lesions, and those with ischemic involvement of the cerebellum or basal ganglia were not allowed to participate.
- Participants having metal implants e. g cardiac pacemaker and skin lesion at the site of stimulation electrodes were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital
Lahore, Punjab Province, 54660
Aruba Saeed, 344399403, arubasaeedpt@gmail.com
About this study
Official title: Combined Effects of Segmental Vibrator With Neuromuscular Electrical Stimulation for Dorsiflexors on Lower Limb Function in Subacute Stroke
Stroke is one of the world's leading causes of death and disability. It can cause a variety of motor disorders, such as apraxia, sensory deficits, abnormal muscle tone, inadequate weight transfer, lack of fine motor skills, incoordination, and balance deficit. These disorders can have a significant negative impact on a person's quality of life.
Read the detailed description
The definition of a stroke, as given by the World Health Organization (WHO), is a clinical illness that includes focused disruptions in cerebral functioning that develop quickly and have a vascular origin. Cerebrovascular accidents, or strokes, rank third in the world in terms of disability and are the second major cause of mortality. A stroke is a major cause of dementia and depression. A stroke is the abrupt death of some brain cells from a lack of oxygen when blood supply to the brain is interrupted by an artery rupturing or blocking the brain. Across the world, low- and middle-income nations account for 70% of stroke cases and 87% of stroke-related fatalities as well as disability-adjusted life years. Patients who have had a stroke often experience a variety of motor disorders, such as dysphagia and dysarthria, imbalance issues, apraxia, sensory deficiencies, abnormal muscle tone, abnormal motor pattern, inadequate weight transfer, lack of fine motor skills, and muscle weakness. After completing their rehabilitation, 50% to 60% of stroke patients still have some degree of motor impairments, and at least 50% of these patients depend on their daily activities. Muscle paresis and spasticity are two of the most prevalent stroke disabilities.
This study aims to explore the effects of combining focal vibration (FV) with electrical neuromuscular stimulation (NMES) on the ankle dorsiflexors in subacute stroke patients. These techniques are relatively new in neurorehabilitation and have shown promise in reducing muscle stiffness and enhancing movement compared to traditional physiotherapy methods. By focusing on the lower limb issues commonly seen after a stroke, we seek to understand how this combination therapy can improve motor function in these patients. The findings of this study could help in developing more effective treatment strategies for stroke survivors dealing with lower limb dysfunction.
- Conditions
- Subacute Stroke, Ischemic Stroke
- Being tested
- Experimental Group A: Segmental vibrator only on dorsiflexor, Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors
- Keywords
- Dorsiflexion, FMA, NEMS, Segmental muscle vibrator, Stroke, Spasticity, Vibration
- Medical subject headings
- Ischemic Stroke, Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group A: Segmental vibrator only on dorsiflexorOther
Segmental vibrator only on dorsiflexor:
After standard physiotherapy session this group received the intervention of segmental vibration. Tibialis anterior muscle targeted for dorsiflexor. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator.
Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexorsOther
Segmental vibrator + Electrical stimulation on dorsiflexors:
After standard physiotherapy session this group received the intervention of neuromuscular electrical stimulations by means of EMS. Two electrodes were used for this procedure. Tibialis anterior muscle targeted for dorsiflexor. One pad of electrode was placed on anterior of lower leg just below tibial tuberisty and other was 5cm below to it .With a 250-microsecond pulse duration, the EMS device was set up to provide a biphasic current with a symmetrical waveform at 50 Hz for 15 seconds. It was also tuned for a 3-second ramp up time and a 30-second rest period. Each respondent set the intensity to the highest level they could tolerate. Secondly, segmental vibrator was applied for focal vibrations on tibialis anterior. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Group A: Standard physical therapy and segmental vibrator on dorsiflexor muscle groups Receives: Other: Experimental Group A: Segmental vibrator only on dorsiflexor |
| group B | Experimental | Group B: Standard physical therapy and segmental vibrator + electrical stimulation on dorsiflexor muscle group Receives: Other: Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (for spasticity)
The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale.
Measured: 8 weeks
Fugl-Meyer Assessment (for lower limb function)
Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total:
- Motor functioning (in the upper and lower extremities)
- Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints)
- Balance (contains 7 tests, 3 seated and 4 standing)
- Joint range of motion (8 joints)
- Joint pain Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total possible scale score is 226.
Measured: 8 weeks
10 Metre Walk Test (mobility)
The 10-Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Gait speed is calculated by dividing the total distance to time
Measured: 8 weeks
Wisconsin Gait Scale (for gait)
Wisconsin Gait Scale (WGS) is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.
Measured: 8 weeks
Goniometer for ROM
A goniometer is a valid clinical tool used to measure the range of motion in joints. It used to measure the ankle dorsiflexion ROM.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- 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
- Model description
- assignment
- 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
- NCT06927206
- Sponsor's protocol ID
- REC//24/0219 Arooj Shahzad
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Segmental Vibrator With Neuromuscular Electrical Stimulation for Dorsiflexors on Lower Limb Function in Subacute Stroke
- ClinicalTrials.gov ID
- NCT06927206
- Acronym / sponsor ID
- REC//24/0219 Arooj Shahzad
- Conditions
- Subacute Stroke, Ischemic Stroke
- Keywords
- Dorsiflexion, FMA, NEMS, Segmental muscle vibrator, Stroke, Spasticity, Vibration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 15 Apr 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 one of the world's leading causes of death and disability. It can cause a variety of motor disorders, such as apraxia, sensory deficits, abnormal muscle tone, inadequate weight transfer, lack of fine motor skills, incoordination, and balance deficit. These disorders can have a significant negative impact on a person's quality of life.
Detailed description
The definition of a stroke, as given by the World Health Organization (WHO), is a clinical illness that includes focused disruptions in cerebral functioning that develop quickly and have a vascular origin. Cerebrovascular accidents, or strokes, rank third in the world in terms of disability and are the second major cause of mortality. A stroke is a major cause of dementia and depression. A stroke is the abrupt death of some brain cells from a lack of oxygen when blood supply to the brain is interrupted by an artery rupturing or blocking the brain. Across the world, low- and middle-income nations account for 70% of stroke cases and 87% of stroke-related fatalities as well as disability-adjusted life years. Patients who have had a stroke often experience a variety of motor disorders, such as dysphagia and dysarthria, imbalance issues, apraxia, sensory deficiencies, abnormal muscle tone, abnormal motor pattern, inadequate weight transfer, lack of fine motor skills, and muscle weakness. After completing their rehabilitation, 50% to 60% of stroke patients still have some degree of motor impairments, and at least 50% of these patients depend on their daily activities. Muscle paresis and spasticity are two of the most prevalent stroke disabilities.
This study aims to explore the effects of combining focal vibration (FV) with electrical neuromuscular stimulation (NMES) on the ankle dorsiflexors in subacute stroke patients. These techniques are relatively new in neurorehabilitation and have shown promise in reducing muscle stiffness and enhancing movement compared to traditional physiotherapy methods. By focusing on the lower limb issues commonly seen after a stroke, we seek to understand how this combination therapy can improve motor function in these patients. The findings of this study could help in developing more effective treatment strategies for stroke survivors dealing with lower limb dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- assignment
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: Experimental Group A: Segmental vibrator only on dorsiflexorGroup A: Standard physical therapy and segmental vibrator on dorsiflexor muscle groups |
| group B | Experimental | Other: Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexorsGroup B: Standard physical therapy and segmental vibrator + electrical stimulation on dorsiflexor muscle group |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Both male and female patients were included in the study.
- The age range of participants was between 45 and 60 years.
- Participants that were diagnosed with ischemic stroke patient.
- Participants had experienced sub-acute ischemic stroke, specifically 15 days to 12 weeks post-stroke.
- Montreal Cognitive Assessment scores falling within the range of 18-24 were necessary.
Key exclusion criteria (5 listed)
- People who had a history of serious neurological or mental conditions that would have impeded lower limb motor recovery-aside from stroke-were not included.
- Individuals with severe arthritis or joint injuries, among other illnesses that would have interfered with treatment or evaluations, were not allowed to participate.
- Individuals who had significant hearing or vision impairments that would have hampered treatment or evaluations were not included.
- Individuals undergoing anti-spatial therapy or other clinical trials, those with bilateral brain lesions, and those with ischemic involvement of the cerebellum or basal ganglia were not allowed to participate.
- Participants having metal implants e. g cardiac pacemaker and skin lesion at the site of stimulation electrodes were excluded.
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 |
|---|---|---|
| Experimental Group A: Segmental vibrator only on dorsiflexorSegmental vibrator only on dorsiflexor: After standard physiotherapy session this group received the intervention of segmental vibration. Tibialis anterior muscle targeted for dorsiflexor. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator. | Other | group A |
| Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexorsSegmental vibrator + Electrical stimulation on dorsiflexors: After standard physiotherapy session this group received the intervention of neuromuscular electrical stimulations by means of EMS. Two electrodes were used for this procedure. Tibialis anterior muscle targeted for dorsiflexor. One pad of electrode was placed on anterior of lower leg just below tibial tuberisty and other was 5cm below to it .With a 250-microsecond pulse duration, the EMS device was set up to provide a biphasic current with a symmetrical waveform at 50 Hz for 15 seconds. It was also tuned for a 3-second ramp up time and a 30-second rest period. Each respondent set the intensity to the highest level they could tolerate. Secondly, segmental vibrator was applied for focal vibrations on tibialis anterior. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator. | Other | group B |
Primary outcome
Modified Ashworth Scale (for spasticity)
Time frame: 8 weeks
The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale.
Fugl-Meyer Assessment (for lower limb function)
Time frame: 8 weeks
Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: * Motor functioning (in the upper and lower extremities) * Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints) * Balance (contains 7 tests, 3 seated and 4 standing) * Joint range of motion (8 joints) * Joint pain Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total possible scale score is 226.
10 Metre Walk Test (mobility)
Time frame: 8 weeks
The 10-Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Gait speed is calculated by dividing the total distance to time
Wisconsin Gait Scale (for gait)
Time frame: 8 weeks
Wisconsin Gait Scale (WGS) is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.
Goniometer for ROM
Time frame: 8 weeks
A goniometer is a valid clinical tool used to measure the range of motion in joints. It used to measure the ankle dorsiflexion ROM.
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group A: Segmental vibrator only on dorsiflexor and Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors in people with Subacute Stroke and Ischemic Stroke, run by Riphah International University at 1 site 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 9 inclusion and 5 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 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Aruba Saeed, Phd (03344399403, arubasaeedpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (for spasticity) (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.