StrokeNCT06893653
Focal Muscle Vibration and tDCS on Motor Recovery in Stroke
A study testing Focal muscle vibration, tDCS and Physical Therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Although tDCS and FV have shown some benefit as stand-alone treatment, researcher suggest that combining intervention with complementary mechanism can lead to additive or synergistic benefits which might yield more significant improvement in functional outcome hence the author propose to plan the combination of FV… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Focal muscle vibration, tDCS and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic stroke
- Spasticity > 1 at Modified Ashworth Scale.
- FMA score more than 36
Who cannot join
- Metallic implant including shunt, intracranial pacemaker, surgical clip etc.
- Any neurological disorder other than stroke
- Any Orthopedic impairment that limit the motor recovery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Focal Muscle Vibration and tDCS on Motor Recovery in Stroke
Although tDCS and FV have shown some benefit as stand-alone treatment, researcher suggest that combining intervention with complementary mechanism can lead to additive or synergistic benefits which might yield more significant improvement in functional outcome hence the author propose to plan the combination of FV with tDCS for motor recovery /spasticity in stroke patients.
Read the detailed description
A stroke is a medical condition characterized by a sudden, localized, loss of neurological function resulting from damage to the blood vessels in the central nervous system. It is a prevalent condition globally and leading cause of disability impairing motor function and significantly impact daily activities and work. 26% of individuals with stroke have a disability in ADLS and 50% have motor impairment gait disorder contribute to 20 to 30%. Spasticity 25%-40% which ultimately affect the quality of life of patients.
Spasticity arises from central nervous system damage where the loss of cortical neurons reduces descending inhibitory control over the spinal cord, affecting the balance between inhibitory and excitatory inputs leading to disinhibition of spinal reflexes causing hyperexcitability of stretch reflexes increase H reflex activity and impaired reciprocal inhibition.Fastest city interacts with weakness resulting in disabling motor impairments and complex complication like muscle contractor motor dysfunction and plastic paint which negatively impacts on patients quality of life.
Noninvasive brain stimulation (NIBS) has been seen more common in rehabilitation setting as an add on therapy to conventional rehabilitative treatment. The main goal of NIBS is to create neuromodulation by inhibiting or activating neural activity in the targeted cortical region. There are different modalities used for NIBS most widely used are transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). tDCS involves a small current to the scalp aiming to modulate cortical excitability. Typical configuration of tDCS are the anode electrode place over the brain area of interest aiming to increase excitation and the cathode electrode placed as a reference, over contra lesional hemisphere aiming to decrease excitability and all electrode taste as a reference such as if she does not supra orbital region. In stroke recovery tDCS is often used to either enhance excitability in the lesioned hemisphere or suppress in the non-lesioned hemisphere to rebalance neural activity. The core concept of tDCS is operating on a simple principle, i.e. the positive terminal of the battery also referred to as the anode is connected to one special location on the head and the negative terminal or cathode is attached at the other end of the head. An electromotive force is generated between these two contact points on the head that creates a potential difference. This difference push positively charged ions that are potassium, sodium and calcium away from the anode towards the cathode this when way neurons that are located under the anode get a boost for excitation and at the same time inhibition occurs at the cathode and that's how whole brain activity is modulated.
Another intervention strategy that has potential for sustainable stroke rehabilitation is the use of mechanical vibration as a therapeutic intervention known as vibration therapy. Focal vibration (FV) reduces muscles spasticity, facilitate muscle contraction and stimulates the proper system to obtain efficient motor control during functional activities. In FV, mechanical vibrations are applied to localized muscles generally the muscle belly or the tendon on the affected side. The suggested mechanism of action of focal vibration on spasticity is depression of the H-reflex within the spinal motor neuron and reciprocal inhibition between the agonist and antagonist muscles.
A study was done aimed to assist the current evidence on the effect of tDCS on upper limb motor function and identified evidence suggest that tDCS has a superior effect in improving function of upper lamp in patient who had a stroke. In 2019, meta-analysis was done to explore the effect of tDCS on different stages of stroke (acute, sub-acute, chronic) and result show that tDCS had a significant effect in the patient of chronic group. Stronger connectivity of ipsilesional and the parietal cortex and contra lesional frontotemporal cortex was found to be associated with an increase in cortico spinal excitability following the anodal tDCS in chronic stroke survivors. A meta-analysis of multiple session reviewed how tDCS parameters influence upper limb function and demonstrate that tDCS applied during therapy yield significant results.
- Conditions
- Stroke
- Being tested
- Focal muscle vibration, tDCS, Physical Therapy, Focal muscle vibration & tDCS
- Keywords
- stroke, tDCS, motor activity, spasticity
- Medical subject headings
- Stroke, Motor Activity, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal muscle vibrationDevice
FMV will be applied to the muscle belly along with the conventional physical therapy
tDCSDevice
tDCS will be applied to M1 area of brain along with the conventional physical therapy
Physical TherapyOther
Conventional physical therapy will be provided
Focal muscle vibration & tDCSDevice
Focal muscle vibration with tDCS and conventional physical therapy will be provided.
| Study group | Role | What they receive |
|---|---|---|
| FMV | Active comparator | FMV + PT Receives: Device: Focal muscle vibration; Other: Physical Therapy |
| tDCS | Active comparator | tDCS + PT Receives: Device: tDCS; Other: Physical Therapy |
| FMV & tDCS | Active comparator | FMV + tDCS + PT Receives: Other: Physical Therapy; Device: Focal muscle vibration & tDCS |
| PT | Active comparator | PT only Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyr Assessment
FMA is used for the assessment of physical performance and sensorimotor function of neurological patients. It uses a 3-point ordinal scale to score individuals' ability to perform a certain task. Total score is 226. It has excellent inter and intrarater reliability
Measured: 20th week
Modified Ashworth Scale
MAS is a tool to measure hypertonia. It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia. Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94) and lower extremities(k= 0.55-0.97) while interrater reliability was poor to moderate for upper (k= 0.25-0.66) and lower extremities
Measured: 20th week
Secondary outcomes (1)
Stroke Specific Quality of Life questionnaire
It is used for estimating the quality of life of stroke patients. It contains 49 questions related to different personal and social aspects. Scoring is done on a ordinal scale of 1-5 with an increase score indicating independence. It is a valid and reliable tool to use in stroke population
Measured: 20th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Apr 2025
- Primary completion31 Jan 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893653
- Sponsor's protocol ID
- Maliha REC02168
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chow AD, Shin J, Wang H, Kellawan JM, Pereira HM. Influence of Transcranial Direct Current Stimulation Dosage and Associated Therapy on Motor Recovery Post-stroke: A Systematic Review and Meta-Analysis. Front Aging Neurosci. 2022 Mar 18;14:821915. doi: 10.3389/fnagi.2022.821915. eCollection 2022.
PubMed 35370603Wang H, Yu H, Liu M, Xu G, Guo L, Wang C, Sun C. Effects of tDCS on brain functional network of patients after stroke. IEEE Access. 2020 Nov 13;8:205625-34
Wang H, Chandrashekhar R, Rippetoe J, Ghazi M. Focal muscle vibration for stroke rehabilitation: a review of vibration parameters and protocols. Applied Sciences. 2020 Nov 21;10(22):8270
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Focal Muscle Vibration and tDCS on Motor Recovery in Stroke
- ClinicalTrials.gov ID
- NCT06893653
- Acronym / sponsor ID
- Maliha REC02168
- Conditions
- Stroke
- Keywords
- stroke, tDCS, motor activity, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 25 Mar 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.
Although tDCS and FV have shown some benefit as stand-alone treatment, researcher suggest that combining intervention with complementary mechanism can lead to additive or synergistic benefits which might yield more significant improvement in functional outcome hence the author propose to plan the combination of FV with tDCS for motor recovery /spasticity in stroke patients.
Detailed description
A stroke is a medical condition characterized by a sudden, localized, loss of neurological function resulting from damage to the blood vessels in the central nervous system. It is a prevalent condition globally and leading cause of disability impairing motor function and significantly impact daily activities and work. 26% of individuals with stroke have a disability in ADLS and 50% have motor impairment gait disorder contribute to 20 to 30%. Spasticity 25%-40% which ultimately affect the quality of life of patients.
Spasticity arises from central nervous system damage where the loss of cortical neurons reduces descending inhibitory control over the spinal cord, affecting the balance between inhibitory and excitatory inputs leading to disinhibition of spinal reflexes causing hyperexcitability of stretch reflexes increase H reflex activity and impaired reciprocal inhibition.Fastest city interacts with weakness resulting in disabling motor impairments and complex complication like muscle contractor motor dysfunction and plastic paint which negatively impacts on patients quality of life.
Noninvasive brain stimulation (NIBS) has been seen more common in rehabilitation setting as an add on therapy to conventional rehabilitative treatment. The main goal of NIBS is to create neuromodulation by inhibiting or activating neural activity in the targeted cortical region. There are different modalities used for NIBS most widely used are transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). tDCS involves a small current to the scalp aiming to modulate cortical excitability. Typical configuration of tDCS are the anode electrode place over the brain area of interest aiming to increase excitation and the cathode electrode placed as a reference, over contra lesional hemisphere aiming to decrease excitability and all electrode taste as a reference such as if she does not supra orbital region. In stroke recovery tDCS is often used to either enhance excitability in the lesioned hemisphere or suppress in the non-lesioned hemisphere to rebalance neural activity. The core concept of tDCS is operating on a simple principle, i.e. the positive terminal of the battery also referred to as the anode is connected to one special location on the head and the negative terminal or cathode is attached at the other end of the head. An electromotive force is generated between these two contact points on the head that creates a potential difference. This difference push positively charged ions that are potassium, sodium and calcium away from the anode towards the cathode this when way neurons that are located under the anode get a boost for excitation and at the same time inhibition occurs at the cathode and that's how whole brain activity is modulated.
Another intervention strategy that has potential for sustainable stroke rehabilitation is the use of mechanical vibration as a therapeutic intervention known as vibration therapy. Focal vibration (FV) reduces muscles spasticity, facilitate muscle contraction and stimulates the proper system to obtain efficient motor control during functional activities. In FV, mechanical vibrations are applied to localized muscles generally the muscle belly or the tendon on the affected side. The suggested mechanism of action of focal vibration on spasticity is depression of the H-reflex within the spinal motor neuron and reciprocal inhibition between the agonist and antagonist muscles.
A study was done aimed to assist the current evidence on the effect of tDCS on upper limb motor function and identified evidence suggest that tDCS has a superior effect in improving function of upper lamp in patient who had a stroke. In 2019, meta-analysis was done to explore the effect of tDCS on different stages of stroke (acute, sub-acute, chronic) and result show that tDCS had a significant effect in the patient of chronic group. Stronger connectivity of ipsilesional and the parietal cortex and contra lesional frontotemporal cortex was found to be associated with an increase in cortico spinal excitability following the anodal tDCS in chronic stroke survivors. A meta-analysis of multiple session reviewed how tDCS parameters influence upper limb function and demonstrate that tDCS applied during therapy yield significant results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FMV | Active comparator | Device: Focal muscle vibration, Other: Physical TherapyFMV + PT |
| tDCS | Active comparator | Device: tDCS, Other: Physical TherapytDCS + PT |
| FMV & tDCS | Active comparator | Other: Physical Therapy, Device: Focal muscle vibration & tDCSFMV + tDCS + PT |
| PT | Active comparator | Other: Physical TherapyPT only |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic stroke
- Spasticity > 1 at Modified Ashworth Scale.
- FMA score more than 36
Key exclusion criteria (3 listed)
- Metallic implant including shunt, intracranial pacemaker, surgical clip etc.
- Any neurological disorder other than stroke
- Any Orthopedic impairment that limit the motor recovery
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 |
|---|---|---|
| Focal muscle vibrationFMV will be applied to the muscle belly along with the conventional physical therapy | Device | FMV |
| tDCStDCS will be applied to M1 area of brain along with the conventional physical therapy | Device | tDCS |
| Physical TherapyConventional physical therapy will be provided | Other | FMV, FMV & tDCS, PT, tDCS |
| Focal muscle vibration & tDCSFocal muscle vibration with tDCS and conventional physical therapy will be provided. | Device | FMV & tDCS |
Primary outcome
Fugl Meyr Assessment
Time frame: 20th week
FMA is used for the assessment of physical performance and sensorimotor function of neurological patients. It uses a 3-point ordinal scale to score individuals' ability to perform a certain task. Total score is 226. It has excellent inter and intrarater reliability
Modified Ashworth Scale
Time frame: 20th week
MAS is a tool to measure hypertonia. It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia. Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94) and lower extremities(k= 0.55-0.97) while interrater reliability was poor to moderate for upper (k= 0.25-0.66) and lower extremities
1 secondary outcome
Stroke Specific Quality of Life questionnaire
Time frame: 20th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 35370603Chow AD, Shin J, Wang H, Kellawan JM, Pereira HM. Influence of Transcranial Direct Current Stimulation Dosage and Associated Therapy on Motor Recovery Post-stroke: A Systematic Review and Meta-Analysis. Front Aging Neurosci. 2022 Mar 18;14:821915. doi: 10.3389/fnagi.2022.821915. eCollection 2022.
- BackgroundWang H, Yu H, Liu M, Xu G, Guo L, Wang C, Sun C. Effects of tDCS on brain functional network of patients after stroke. IEEE Access. 2020 Nov 13;8:205625-34
- BackgroundWang H, Chandrashekhar R, Rippetoe J, Ghazi M. Focal muscle vibration for stroke rehabilitation: a review of vibration parameters and protocols. Applied Sciences. 2020 Nov 21;10(22):8270
- 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. This study is not recruiting at the moment.
Mirza Obaid Baig, MSPT 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 Focal muscle vibration, tDCS and Physical Therapy in people with 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 8 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyr Assessment (time frame: 20th week). The study lists 2 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 NCT06893653, which also lists 3 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 8 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.