Post StrokeNCT07718776
Comparative Effects of SBES Versus TOT on Lower Limb Motor Function in Post-Stroke Patients
A study testing synergy Based Electrical stimulation and Task oriented training in people with Post Stroke and Lower Limb, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke-induced lower limb impairments severely inhibit functional independence and mobility in survivors. Inventive techniques like Synergy-Based Electrical Stimulation (SBES) and Task-Oriented Training (TOT) support favorable rehabilitation results based on Neuroplasticity. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Post Stroke, Lower Limb
- What is being tested?
- synergy Based Electrical stimulation and Task oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2026to 6 Aug 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 40 to 60 years
- Both Male and Female participants
- In the sub-acute phase of stroke (1-6 months post-stroke) with lower limb motor impairment but with the ability to initiate at least trace muscle contraction (Grade ≥ 1).
- Participants must have the ability to understand and follow simple verbal commands with the Mini-Mental State Examination (MMSE) ≥ 26.
- Participants must have a first-ever ischemic and hemorrhagic stroke in the sub-acute stage.
- Participants who are functionally ambulatory and able to walk a minimum of 10 feet, with or without the use of assistive devices with a Functional Ambulation Category (FAC) score ≥ 2.
Who cannot join
- Participants have severe cognitive impairment and an inability to understand or follow instructions, and severe sensory impairment with profound sensory loss in the lower limb affecting balance or feedback-based training.
- Participants having orthopedic limitations like recent fractures, joint deformities, or surgeries affecting the lower limbs.
- Participants having implanted electrical devices like pacemakers are contraindicated for electrical stimulation
- Participants having a history of more than one stroke episode and or multiple infarcts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Synergy-Based Electrical Stimulation Versus Task-Oriented Training on Lower Limb Motor Function in Post-Stroke Patients
Stroke-induced lower limb impairments severely inhibit functional independence and mobility in survivors. Inventive techniques like Synergy-Based Electrical Stimulation (SBES) and Task-Oriented Training (TOT) support favorable rehabilitation results based on Neuroplasticity. This study aims to compare the effectiveness of these in restoring purposeful movements and enhancing motor functions in post-stroke patients.This study aims to compare the efficacy of (SBES) and Task-Oriented Training (TOT) in improving lower limb motor control in sub-acute post-stroke patients.
This study will be a single-blinded randomized clinical trial design. Participants, aged 40-60 will be recruited in this study by Non-Probability convenience sampling from Rehabilitation centers and Neurology departments. Informed consent and consistent attendance throughout the intervention will be required. Through the computerized table generator method of randomization, participants will be evenly divided into two groups. Both groups will receive conventional therapy, like stretching, strengthening, and isometrics, with modalities. Group A will receive 30 Hz electrical stimulation on the affected lower limb muscles (hip flexors, knee flexors, and ankle dorsiflexors) in a synergic pattern, for 60 minutes, thrice weekly for 6 weeks. Group B will engage in functional tasks for 60 minutes, thrice weekly for 6 weeks, repeated 10 times per set with 2 sets of each activity, plus an additional self-practice session. Outcome measures will be assessed at baseline and post-intervention stages by the Fugl-Meyer Assessment for motor recovery, Time UP and Go Test (TUG) and 10 Meter Walk Test for functional mobility, gait, and balance. The paired sample t-test will be used for within-group analysis in the parametric data and the Wilcoxon test for non-parametric data, whereas, for between-group analysis independent t-test will be used for parametric data and Mann Whitney U test will be used for non-parametric data. Statistical analysis will be done by using SPSS version 26.
Keywords: Lower Limb, motor control, SBES, Strength, Stroke, TOT.
Read the detailed description
The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study.
RECRUITMENT:
Eligible participants will be recruited from Neurology departments and Rehabilitation centers.
RANDOMIZATION:
Patients will be recruited using a non-probability convenience sampling technique, and then they will be divided into two groups by simple random sampling through sealed, opaque envelopes.
BLINDNESS:
This study will be a single-blinded study in which the outcome assessor will be blind.
INTERVENTION:
Participants who will meet the inclusion criteria will be recruited, and written informed consent will be obtained before enrollment. The initial assessment will include the Fugl-Meyer Assessment to measure motor recovery and the 10-M Walk Test and TUG to evaluate functional mobility. Participants will be allocated to either the Synergy-Based Electrical Stimulation (SBES) group or the Task-Oriented Training group.
- Conditions
- Post Stroke, Lower Limb
- Being tested
- synergy Based Electrical stimulation, Task oriented training
- Keywords
- Synergy based electrical stimulation, Task oriented training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synergy Based Electrical stimulationOther
Synergy based visible but comfortable muscle contraction in semi-supine position, surface electrodes on hip and knee flexors and dorsiflexors.• Intensity adjusted based on tolerance
- Monitor muscle response and patient comfort
Task oriented trainingOther
Tot Sit-to-stand, reaching, weight shifting, gait training, ball-kicking, tandem/side walking• Increase intensity by slightly reducing assistance
- Add unstable surfaces for gait
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Hot pack and isometric exercises Receives: Other: synergy Based Electrical stimulation; Other: Task oriented training |
| Conventional Therapy | Active comparator | Hot pack and isometric exercises Receives: Other: synergy Based Electrical stimulation; Other: Task oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment:
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE) is a reliable tool to evaluate motor recovery in post-stroke patients. It consists of 17 items divided into five sections: reflex activity, volitional movement within synergy, mixing synergies, movement with little or no synergy, and coordination/speed. Each item is scored from 0 to 2, giving a maximum score of 34. Higher scores indicate better motor function. Reflex activity includes 3 items (max 6 points), synergy movements have 6 items (12 points), mixed synergy includes 2 items (4 points), isolated movements have 3 items (6 points), and coordination/speed includes 3 items (6 points). The heel-to-shin test is used for coordination. Scoring interpretation is: 0-10 severe, 11-20 moderate, 21-29 mild, and 30-34 minimal impairment. It takes 20-30 minutes and is administered by a trained professional.
Measured: Baseline to 4 weeks
The Timed Up and Go (TUG) Test
This is a quick and reliable assessment used to evaluate mobility, balance, and fall risk in older adults and patients with neurological conditions like stroke. It involves timing how long it takes for a person to stand from a chair, walk three meters, turn, return, and sit down. Times under 10 seconds indicate normal mobility, while over 30 seconds suggest high fall risk. The test is simple, requires minimal equipment, and is widely used in clinical and rehabilitation settings. It helps monitor patient progress and guides treatment planning.
Measured: Baseline to 4 weeks
10-Meter Walk Test
The 10MWT is a quick and reliable assessment of gait speed over a short distance, commonly used in stroke rehabilitation. It involves timing a patient when they walk a 10-m path, typically within a 14-m walkaway to account for acceleration and deceleration. The test can be performed at a comfortable or fast pace. Gait speed is calculated in meters per second and is considered a strong predictor of functional mobility, fall risk, and community ambulation. It is widely used to monitor progress in stroke patients.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start5 Jun 2026
- Primary completion6 Aug 2026 (estimated)
- Study completion6 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718776
- Sponsor's protocol ID
- REC/RCR & AHS/25/0211
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 22 Jul 2026
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Synergy-Based Electrical Stimulation Versus Task-Oriented Training on Lower Limb Motor Function in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07718776
- Acronym / sponsor ID
- REC/RCR & AHS/25/0211
- Conditions
- Post Stroke, Lower Limb
- Keywords
- Synergy based electrical stimulation, Task oriented training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 6 Aug 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 22 Jul 2026 (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-induced lower limb impairments severely inhibit functional independence and mobility in survivors. Inventive techniques like Synergy-Based Electrical Stimulation (SBES) and Task-Oriented Training (TOT) support favorable rehabilitation results based on Neuroplasticity. This study aims to compare the effectiveness of these in restoring purposeful movements and enhancing motor functions in post-stroke patients.This study aims to compare the efficacy of (SBES) and Task-Oriented Training (TOT) in improving lower limb motor control in sub-acute post-stroke patients.
This study will be a single-blinded randomized clinical trial design. Participants, aged 40-60 will be recruited in this study by Non-Probability convenience sampling from Rehabilitation centers and Neurology departments. Informed consent and consistent attendance throughout the intervention will be required. Through the computerized table generator method of randomization, participants will be evenly divided into two groups. Both groups will receive conventional therapy, like stretching, strengthening, and isometrics, with modalities. Group A will receive 30 Hz electrical stimulation on the affected lower limb muscles (hip flexors, knee flexors, and ankle dorsiflexors) in a synergic pattern, for 60 minutes, thrice weekly for 6 weeks. Group B will engage in functional tasks for 60 minutes, thrice weekly for 6 weeks, repeated 10 times per set with 2 sets of each activity, plus an additional self-practice session. Outcome measures will be assessed at baseline and post-intervention stages by the Fugl-Meyer Assessment for motor recovery, Time UP and Go Test (TUG) and 10 Meter Walk Test for functional mobility, gait, and balance. The paired sample t-test will be used for within-group analysis in the parametric data and the Wilcoxon test for non-parametric data, whereas, for between-group analysis independent t-test will be used for parametric data and Mann Whitney U test will be used for non-parametric data. Statistical analysis will be done by using SPSS version 26.
Keywords: Lower Limb, motor control, SBES, Strength, Stroke, TOT.
Detailed description
The synopsis will be presented to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval to conduct this study.
RECRUITMENT:
Eligible participants will be recruited from Neurology departments and Rehabilitation centers.
RANDOMIZATION:
Patients will be recruited using a non-probability convenience sampling technique, and then they will be divided into two groups by simple random sampling through sealed, opaque envelopes.
BLINDNESS:
This study will be a single-blinded study in which the outcome assessor will be blind.
INTERVENTION:
Participants who will meet the inclusion criteria will be recruited, and written informed consent will be obtained before enrollment. The initial assessment will include the Fugl-Meyer Assessment to measure motor recovery and the 10-M Walk Test and TUG to evaluate functional mobility. Participants will be allocated to either the Synergy-Based Electrical Stimulation (SBES) group or the Task-Oriented Training group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Other: synergy Based Electrical stimulation, Other: Task oriented trainingHot pack and isometric exercises |
| Conventional Therapy | Active comparator | Other: synergy Based Electrical stimulation, Other: Task oriented trainingHot pack and isometric exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 40 to 60 years
- Both Male and Female participants
- In the sub-acute phase of stroke (1-6 months post-stroke) with lower limb motor impairment but with the ability to initiate at least trace muscle contraction (Grade ≥ 1).
- Participants must have the ability to understand and follow simple verbal commands with the Mini-Mental State Examination (MMSE) ≥ 26.
- Participants must have a first-ever ischemic and hemorrhagic stroke in the sub-acute stage.
Key exclusion criteria (4 listed)
- Participants have severe cognitive impairment and an inability to understand or follow instructions, and severe sensory impairment with profound sensory loss in the lower limb affecting balance or feedback-based training.
- Participants having orthopedic limitations like recent fractures, joint deformities, or surgeries affecting the lower limbs.
- Participants having implanted electrical devices like pacemakers are contraindicated for electrical stimulation
- Participants having a history of more than one stroke episode and or multiple infarcts.
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 |
|---|---|---|
| synergy Based Electrical stimulationSynergy based visible but comfortable muscle contraction in semi-supine position, surface electrodes on hip and knee flexors and dorsiflexors.• Intensity adjusted based on tolerance • Monitor muscle response and patient comfort | Other | Conventional Therapy, Therapy |
| Task oriented trainingTot Sit-to-stand, reaching, weight shifting, gait training, ball-kicking, tandem/side walking• Increase intensity by slightly reducing assistance • Add unstable surfaces for gait | Other | Conventional Therapy, Therapy |
Primary outcome
Fugl-Meyer Assessment:
Time frame: Baseline to 4 weeks
The Fugl-Meyer Assessment for Lower Extremity (FMA-LE) is a reliable tool to evaluate motor recovery in post-stroke patients. It consists of 17 items divided into five sections: reflex activity, volitional movement within synergy, mixing synergies, movement with little or no synergy, and coordination/speed. Each item is scored from 0 to 2, giving a maximum score of 34. Higher scores indicate better motor function. Reflex activity includes 3 items (max 6 points), synergy movements have 6 items (12 points), mixed synergy includes 2 items (4 points), isolated movements have 3 items (6 points), and coordination/speed includes 3 items (6 points). The heel-to-shin test is used for coordination. Scoring interpretation is: 0-10 severe, 11-20 moderate, 21-29 mild, and 30-34 minimal impairment. It takes 20-30 minutes and is administered by a trained professional.
The Timed Up and Go (TUG) Test
Time frame: Baseline to 4 weeks
This is a quick and reliable assessment used to evaluate mobility, balance, and fall risk in older adults and patients with neurological conditions like stroke. It involves timing how long it takes for a person to stand from a chair, walk three meters, turn, return, and sit down. Times under 10 seconds indicate normal mobility, while over 30 seconds suggest high fall risk. The test is simple, requires minimal equipment, and is widely used in clinical and rehabilitation settings. It helps monitor patient progress and guides treatment planning.
10-Meter Walk Test
Time frame: Baseline to 4 weeks
The 10MWT is a quick and reliable assessment of gait speed over a short distance, commonly used in stroke rehabilitation. It involves timing a patient when they walk a 10-m path, typically within a 14-m walkaway to account for acceleration and deceleration. The test can be performed at a comfortable or fast pace. Gait speed is calculated in meters per second and is considered a strong predictor of functional mobility, fall risk, and community ambulation. It is widely used to monitor progress in stroke patients.
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 22 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synergy Based Electrical stimulation and Task oriented training in people with Post Stroke and Lower Limb, 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 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?
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?
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-Meyer Assessment: (time frame: Baseline to 4 weeks). The study lists 3 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 22 Jul 2026.