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StrokeNCT07576465

Effects of SBMT Combined With NMES on UL Functions in Post Stroke Patients

A study testing Synergy-based motor therapy, Neuromuscular electrical stimulation and Conventional therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study to evaluate the effects of synergy-based motor therapy combined with neuromuscular electric stimulation on upper limb function on post stroke patients Read more about this study

Who is it for?
Ages 50 to 65 months
Conditions the study is for
Stroke
What is being tested?
Synergy-based motor therapy, Neuromuscular electrical stimulation and Conventional therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
1 Apr 2026to Jul 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 65 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1) Age :50 to 65 2) Both male and female 3) Ischemic Stroke onset among 3 to 6 months (sub-acute section) 4) Hemiplegia affected upper limb 5) The score of Modified ash worth scale rating <2 for upper limb 6) The score of Mini mental state score >25

Who cannot join

  • 1) Recurrent stroke or bilateral involvement 2) Cognitive or conversation impairment 3) Presence of pacemaker or contraindications to NMES 4) Uncontrolled comorbid situation (e.g extreme cardiac diseases )

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
  • District Head Quarter Hospital , Jhang

    Jhang, Punjab Province, 35200

    Hira Jabeen, MS, 03234116506, hira.jabeen@riphah.edu.pk

    Jasia Fatima, MS(NMPT)

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Synergy-based Motor Therapy Combined With Neuromuscular Electrical Stimulation in Post Stroke Patients

The aim of this study to evaluate the effects of synergy-based motor therapy combined with neuromuscular electric stimulation on upper limb function on post stroke patients

Read the detailed description

Stroke is a serious medical condition that affects blood flow of brain due to ischemic stroke or hemorrhagic stroke. It because the long-term disabilities most commonly in older adults. The challenges face after stroke is weakness, loss of functions in upper limb.(1) Patients also feel difficulty in daily life activities like eating, dressing, writing, holding objects. In previous years, many therapeutic approaches have been developed to improve upper limb functions after stroke. There is most promising techniques like synergy-based motor therapy and NMES and these techniques helps patients in different ways. (2) Synergy-based motor therapy (SBMT) is a therapeutic approach designed to address unusual synergy patterns usually seen after stroke. Its purpose is to restore voluntary control and promote separate joint movements by returning motor routes.(3) Neuromuscular Electrical Stimulation (NMES) is a minor that distributes low-existing electrical impulses to stimulate muscle contractions in weak or paralyzed muscles, leading to muscle strength, motor learning and functional recovery.(4) More effective intervention can be offered by mixing SBMT with NMES together by addressing nerve control and muscle activity.

Synergy-based motor therapy is to focuses on retraining the brain to allow natural movements of the arm and hand. This therapy is based on how the brain learns and adapts (neuroplasticity)(5) It helps patients practice specific tasks and movements that target the upper limb joints, like shoulder abduction, elbow extension, and wrist control. Over time, this type of therapy can improve coordination, range of motion, and function of the affected arm.(6) The upper limb plays a vital role in daily living. Even simple actions like buttoning a shirt or brushing teeth require coordination between the hand, wrist, elbow, and shoulder. When stroke disrupts this system, the person becomes dependent on others. Synergy-based motor therapy directly targets the impaired patterns in the upper limb and helps the patient regain voluntary control. It also reduces muscle tightness (spasticity) and increases active participation of the limb in functional tasks.(7) Another important approach in stroke rehabilitation is neuromuscular electrical stimulation (NMES). In NMES, small electrical impulses are sent through the skin to activate the muscles that the brain can no longer control well. This causes the muscles to contract and helps in maintaining muscle strength, preventing muscle wasting, and encouraging active movement.(8) NMES can be especially helpful for patients who are unable to move their arm due to severe weakness in the early phase of recovery.NMES is not just about stimulating muscles; it also sends feedback to the brain, which can help rebuild the brain-muscle connection. It supports the patient's ability to relearn lost skills. Moreover, NMES can reduce pain, improve blood flow, and increase patient motivation by allowing them to see progress even when they cannot move the limb on their own. This makes it a very useful tool in stroke rehabilitation, especially when used in combination with task-specific exercises.(9) Both therapies have shown positive results individually, combining both therapies may offer even better outcome. Synergy based motor therapy works on retraining the brain and correcting the movement patterns while NMES can assist by strengthening the muscles. Most studies have looked these therapies separately and not focused on older adults which have slower recovery than young adults.(10) This research is important because it addresses a gap in the existing literature by focusing on a specific age group and combining the two effective techniques. The findings help physical therapists and rehabilitation professionals develop more effective, evidence-based treatment plan for post stroke patients to improve the quality of life and independence in daily life.(11) Incorporating synergy-based motor therapy and neuromuscular electrical stimulation (NMES) into routine stroke rehabilitation programs may promote long-term benefits such as enhanced motor recovery, improved functional performance, and greater independence in daily activities among post-stroke patients. These interventions work by activating normal muscle synergies, improving neuromuscular recruitment patterns, and facilitating motor relearning through targeted feedback mechanisms. NMES provides sensory and motor stimulation that helps improve voluntary muscle activation, while synergy-based therapy focuses on restoring coordinated limb movements disrupted by cortical damage. Although both techniques have individually demonstrated positive outcomes in upper limb rehabilitation, comparative studies remain limited. Understanding the combined effect of these therapies in older adults with post-stroke hemiparesis is crucial for evidence-based decision making. The findings may assist clinicians in refining post-stroke rehabilitation approaches and designing more tailored intervention protocols for upper limb recovery.

Conditions
Stroke
Being tested
Synergy-based motor therapy, Neuromuscular electrical stimulation, Conventional therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synergy-based motor therapyBehavioural

    First do the 5 minutes warm up exercises(passive range of motion exercises for shoulder,elbow ,wrist and then synergy based motor therapy for 25 minutes in which the flexor synergy facilitation ( 10 rep,3 sets) and brushing and tapping for sensory cueing and then 5 minutes of cool down exercises(slow passive movements of upper limb)

  • Neuromuscular electrical stimulationDevice

    NMES applied to wrist extensors .Frequency: 35Hz ,Pulse Width250 ,Duty cycle :10s on /20s off ,Duration : 25 minutes

  • Conventional therapyOther

    The conventional therapy group will receive standard physiotherapy for the upper limb for 30-45 minutes per session, five days per week for 6-8 weeks. It will include gentle warm-up, range of motion exercises, light strengthening, and simple functional activities like reaching, grasping, and daily task practice. Each session will end with stretching and relaxation. This treatment aims to improve movement, strength, and function without using NMES or synergy-based training.

Study groups in NCT07576465
Study groupRoleWhat they receive
Synergy-based motor therapy and NMESExperimentalParticipants will receive synergy-based motor therapy combined with neuromuscular electrical stimulation (NMES) for upper limb rehabilitation following stroke. Treatment will focus on improving motor control, functional movement, and muscle activation.
Receives: Behavioral: Synergy-based motor therapy; Device: Neuromuscular electrical stimulation; Other: Conventional therapy
Conventional therapyActive comparatorParticipants will receive conventional physiotherapy for upper limb rehabilitation following stroke, including standard exercises aimed at improving strength, range of motion, and functional ability.
Receives: Behavioral: Synergy-based motor therapy; Device: Neuromuscular electrical stimulation; Other: Conventional therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assesssment _Upper Extremity

    The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a standardized tool used to evaluate motor function in the upper limb of post-stroke patients. It assesses movement, coordination, and reflex activity of the shoulder, elbow, forearm, wrist, and hand. The scale includes 33 items, scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 indicating normal function. It helps classify the severity of motor impairment: scores between 0-22 suggest severe, 23-44 moderate, and 45-66 mild impairment. The FMA-UE is based on Brunnstrom's stages of motor recovery and is widely recognized for its high validity and excellent reliability, with inter-rater and intra-rater reliability scores above 0.95. It is considered one of the most reliable clinical tools for evaluating motor recovery in stroke rehabilitation

    Measured: 8th week

Secondary outcomes (1)
  1. Modified Ashworth Scale (MAS)

    The Modified Ashworth Scale (MAS) is a clinical tool used to measure spasticity in patients with neurological conditions such as stroke. The scale ranges from 0 to 4, with an additional 1+ grade, where 0 indicates no increase in muscle tone, and 4 indicates the affected part is rigid in flexion or extension. The scores reflect the severity of spasticity: higher scores represent greater resistance and spasticity

    Measured: 8th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start1 Apr 2026
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07576465
Sponsor's protocol ID
REC/RCR&AHS/25/0237
Status last verified
May 2026
First submitted
4 May 2026
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

  • Wang C, Peng L, Hou ZG, Li J, Zhang T, Zhao J. Quantitative Assessment of Upper-Limb Motor Function for Post-Stroke Rehabilitation Based on Motor Synergy Analysis and Multi-Modality Fusion. IEEE Trans Neural Syst Rehabil Eng. 2020 Apr;28(4):943-952. doi: 10.1109/TNSRE.2020.2978273. Epub 2020 Mar 4.

    PubMed 32149692
  • Zhou HX, Hu J, Yun RS, Zhao ZZ, Lai MH, Sun LH, Luo KL. Synergy-based functional electrical stimulation and robotic-assisted for retraining reach-to-grasp in stroke: a study protocol for a randomized controlled trial. BMC Neurol. 2023 Sep 12;23(1):324. doi: 10.1186/s12883-023-03369-2.

    PubMed 37700225
  • Niu CM, Chou CH, Bao Y, Wang T, Gu L, Zhang X, Cui L, Xuan Z, Zhuang C, Li S, Chen Z, Lan N, Xie Q. A pilot study of synergy-based FES for upper-extremity poststroke rehabilitation. Neurosci Lett. 2022 May 29;780:136621. doi: 10.1016/j.neulet.2022.136621. Epub 2022 Apr 5.

    PubMed 35395324
  • Wang T, Bao Y, Hao H, Zhang X, Li S, Xie Q, Lan N, Niu CM. Customization of Synergy-Based FES for Post-Stroke Rehabilitation of Upper-Limb Motor Functions. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:3541-3544. doi: 10.1109/EMBC.2018.8513083.

    PubMed 30441143
  • Sorimachi Y, Akaida H, Kutsuzawa K, Owaki D, Hayashibe M. Synergy-Based Evaluation of Hand Motor Function in Object Handling Using Virtual and Mixed Realities. Sensors (Basel). 2025 Mar 26;25(7):2080. doi: 10.3390/s25072080.

    PubMed 40218597
  • Niu CM, Bao Y, Zhuang C, Li S, Wang T, Cui L, Xie Q, Lan N. Synergy-Based FES for Post-Stroke Rehabilitation of Upper-Limb Motor Functions. IEEE Trans Neural Syst Rehabil Eng. 2019 Feb;27(2):256-264. doi: 10.1109/TNSRE.2019.2891004.

    PubMed 30763238
  • Pandian S, Arya KN, Kumar V, Joshi AK. Synergy-Based Motor Therapy Inducing Favorable Changes in Motor Function Components among Poststroke Subjects: A Single-Group Study. J Neurosci Rural Pract. 2022 Mar 8;13(2):261-269. doi: 10.1055/s-0042-1743458. eCollection 2022 Apr.

    PubMed 35694074
  • Bolognini N, Russo C, Edwards DJ. The sensory side of post-stroke motor rehabilitation. Restor Neurol Neurosci. 2016 Apr 11;34(4):571-86. doi: 10.3233/RNN-150606.

    PubMed 27080070

Questions about this trial

What is this clinical trial studying?

A study testing Synergy-based motor therapy, Neuromuscular electrical stimulation and Conventional 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 1 inclusion and 1 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 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?

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 Imran Amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assesssment _Upper Extremity (time frame: 8th week). 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 NCT07576465, which also lists 8 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.

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