Subacute StrokeNCT06686303
Effects of Combined Segmental Vibrator and Neuromuscular Electrical Stimulation in Subacute Stroke
A study testing High frequency Segmental Vibrator and Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation. in people with Subacute Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is leading cause of death and disability worldwide, resulting in significant functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb. There is a need for more effective interventions targeting upper limb sensory motor impairments. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- High frequency Segmental Vibrator and Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 5 Dec 2024
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders
- Aged between 45 and 65 years old
- First ever ischemic stroke experienced more than 3 months before the enrollment
- Spasticity of spastic agonist muscles ranging from 0-2 on the MAS
Who cannot join
- Patients with bilateral brain lesions
- Ischemic involvement of cerebellum or basal ganglia
- Psychiatric disease and cognitive impairment
- Previous history of other neurological diseases,rheumatic and orthopaedic conditions
- Patients under anti-spastic therapy or other clinical trials
- Metal implants e.g. cardiac pacemakers
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Bone and Joint Hospital
Sialkot, Punjab Province, 51310
About this study
Official title: Combined Effects of Segmental Vibrator With Neuromuscular Electrical Stimulation for Flexor and Extensor Muscle Groups on Upper Limb Function in Sub Acute Stroke
Stroke is leading cause of death and disability worldwide, resulting in significant functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb. There is a need for more effective interventions targeting upper limb sensory motor impairments. The aim of this study is to study combined effect of segmental vibrator and neuromuscular electrical stimulation for flexor and extensor muscle groups on upper limb function in sub-acute stroke.
Read the detailed description
This study will be a randomized clinical trial and will be conducted in physiotherapy department of Allama Iqbal Memorial Teaching Hospital Sialkot, National Bone and Joint Hospital and Bashir Hospital Sialkot. Forty stroke patients will be recruited through non-probability convenience sampling technique and will be randomly divided in two equal groups Group A and group B through lottery method. Group A will receive high frequency segmental vibration on flexor and extensor muscle groups while group B will receive neuromuscular electrical stimulation along with high frequency segmental vibration(100Hz) on flexor and extensor muscle groups Data will be collected from patients of sub-acute stroke by using screening tool MoCA(for cognition) and assessment tools Fugl-Meyer Assessment Scale(for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity) , Barthel Index(for ADLs), Maximal Hand Grip Strength(for manual dexterity), Maximal Pinch Grip(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). An informed consent will be taken. Outcome measures will be assessed at baseline, at 4th week and at 8th week. Follow up will be performed at 12th week. Data analysis will be done by SPSS version 28.0.
- Conditions
- Subacute Stroke
- Being tested
- High frequency Segmental Vibrator, Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency Segmental VibratorOther
Segmental vibrations of high frequency was used on each flexor and extensor interspersed with a 1 minute break.
Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.Other
Segmental vibrations of high frequency with Neuromuscular Electrical Stimulation was given on each flexor and extensor.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received the high frequency segmental vibrator. Receives: Other: High frequency Segmental Vibrator |
| Group B | Experimental | Group B received the combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation. Receives: Other: Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoCA(Montreal Cognitive Assessment)
MoCA is a screening tool used to evaluate the cognition in stroke patients. Maximum Score 30 Score > 25 considered normal cognition
Measured: Baseline and 8 weeks
Fugl-Meyer Assessment
Fugl-Meyer is an assessment tool used to evaluate the upper limb function in stroke patients. Upper Extrimity Maximum Score: 66
Measured: Baseline and 8 weeks
Wolf Motor Functional Test
Wolf Motor Functional Test is an assessment tool used to evaluate motor function in stroke patients. The WMFT consists of 15 functional tasks and 2 strength-based tasks (total 17 items). Each task is rated on a 6-point ordinal scale
Measured: Baseline and 8 weeks
Barthel Index
BI is an assessment tool used to evaluate ADLs in stroke patients. Minimum Score: 0 (completely dependent) and Maximum Score: 100 (fully independent)
Measured: Baseline and 8 weeks
Modified Ashworth Scale
MAS is an assessment tool used to evaluate spasticity in stroke patients. Minimum score 0 and maximum score 4
Measured: Baseline and 8 weeks
Maximal Hand and Pinch Grip Strength
Maximal Hand and Pinch Grip Strength is an assessment tool used to evaluate manual dexterity in stroke patients measured by Dynamometer.
Measured: Baseline and 8 weeks
Nottingham Sensory Assessment
Nottingham Sensory Assessment is an assessment tool used to evaluate somatosensory sensation in stroke patients. Minimum Score: 0, Maximum Score: 42 (normal sensation)
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Jan 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
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.
- 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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686303
- Sponsor's protocol ID
- REC/0216 RabiaSaleem
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- 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 9 Apr 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 Flexor and Extensor Muscle Groups on Upper Limb Function in Sub Acute Stroke
- ClinicalTrials.gov ID
- NCT06686303
- Acronym / sponsor ID
- REC/0216 RabiaSaleem
- Conditions
- Subacute Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 13 Nov 2024 (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 leading cause of death and disability worldwide, resulting in significant functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb. There is a need for more effective interventions targeting upper limb sensory motor impairments. The aim of this study is to study combined effect of segmental vibrator and neuromuscular electrical stimulation for flexor and extensor muscle groups on upper limb function in sub-acute stroke.
Detailed description
This study will be a randomized clinical trial and will be conducted in physiotherapy department of Allama Iqbal Memorial Teaching Hospital Sialkot, National Bone and Joint Hospital and Bashir Hospital Sialkot. Forty stroke patients will be recruited through non-probability convenience sampling technique and will be randomly divided in two equal groups Group A and group B through lottery method. Group A will receive high frequency segmental vibration on flexor and extensor muscle groups while group B will receive neuromuscular electrical stimulation along with high frequency segmental vibration(100Hz) on flexor and extensor muscle groups Data will be collected from patients of sub-acute stroke by using screening tool MoCA(for cognition) and assessment tools Fugl-Meyer Assessment Scale(for upper limb function), Wolf Motor Functional Test(for motor function), Modified Ashworth Scale(for spasticity) , Barthel Index(for ADLs), Maximal Hand Grip Strength(for manual dexterity), Maximal Pinch Grip(for manual dexterity), Nottingham Sensory Assessment(for somatosensory function). An informed consent will be taken. Outcome measures will be assessed at baseline, at 4th week and at 8th week. Follow up will be performed at 12th week. Data analysis will be done by SPSS version 28.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: High frequency Segmental VibratorGroup A received the high frequency segmental vibrator. |
| Group B | Experimental | Other: Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.Group B received the combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both genders
- Aged between 45 and 65 years old
- First ever ischemic stroke experienced more than 3 months before the enrollment
- Spasticity of spastic agonist muscles ranging from 0-2 on the MAS
Key exclusion criteria (6 listed)
- Patients with bilateral brain lesions
- Ischemic involvement of cerebellum or basal ganglia
- Psychiatric disease and cognitive impairment
- Previous history of other neurological diseases,rheumatic and orthopaedic conditions
- Patients under anti-spastic therapy or other clinical trials
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 |
|---|---|---|
| High frequency Segmental VibratorSegmental vibrations of high frequency was used on each flexor and extensor interspersed with a 1 minute break. | Other | Group A |
| Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation.Segmental vibrations of high frequency with Neuromuscular Electrical Stimulation was given on each flexor and extensor. | Other | Group B |
Primary outcome
MoCA(Montreal Cognitive Assessment)
Time frame: Baseline and 8 weeks
MoCA is a screening tool used to evaluate the cognition in stroke patients. Maximum Score 30 Score > 25 considered normal cognition
Fugl-Meyer Assessment
Time frame: Baseline and 8 weeks
Fugl-Meyer is an assessment tool used to evaluate the upper limb function in stroke patients. Upper Extrimity Maximum Score: 66
Wolf Motor Functional Test
Time frame: Baseline and 8 weeks
Wolf Motor Functional Test is an assessment tool used to evaluate motor function in stroke patients. The WMFT consists of 15 functional tasks and 2 strength-based tasks (total 17 items). Each task is rated on a 6-point ordinal scale
Barthel Index
Time frame: Baseline and 8 weeks
BI is an assessment tool used to evaluate ADLs in stroke patients. Minimum Score: 0 (completely dependent) and Maximum Score: 100 (fully independent)
Modified Ashworth Scale
Time frame: Baseline and 8 weeks
MAS is an assessment tool used to evaluate spasticity in stroke patients. Minimum score 0 and maximum score 4
Maximal Hand and Pinch Grip Strength
Time frame: Baseline and 8 weeks
Maximal Hand and Pinch Grip Strength is an assessment tool used to evaluate manual dexterity in stroke patients measured by Dynamometer.
Nottingham Sensory Assessment
Time frame: Baseline and 8 weeks
Nottingham Sensory Assessment is an assessment tool used to evaluate somatosensory sensation in stroke patients. Minimum Score: 0, Maximum Score: 42 (normal sensation)
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 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Subacute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Aruba Saeed, MS-NMPT 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 High frequency Segmental Vibrator and Combined effects of high frequency segmental vibrator and neuromuscular electrical stimulation. in people with Subacute 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 4 inclusion and 6 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 9 Apr 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?
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?
MoCA(Montreal Cognitive Assessment) (time frame: Baseline and 8 weeks). The study lists 7 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 9 Apr 2025.