- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07576465
Effects of SBMT Combined With NMES on UL Functions in Post Stroke Patients
Effects of Synergy-based Motor Therapy Combined With Neuromuscular Electrical Stimulation in Post Stroke Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Imran Amjad
- Telefonnummer: 03324390125
- E-post: Imran.amjad@riphah.edu.pk
Studieorter
-
-
Punjab Province
-
Jhang, Punjab Province, Pakistan, 35200
- Rekrytering
- District Head Quarter Hospital , Jhang
-
Kontakt:
- Hira Jabeen, MS
- Telefonnummer: 03234116506
- E-post: hira.jabeen@riphah.edu.pk
-
Underutredare:
- Jasia Fatima, MS(NMPT)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 )
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Synergy-based motor therapy and NMES
Participants 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.
|
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)
NMES applied to wrist extensors .Frequency: 35Hz ,Pulse Width250 ,Duty cycle :10s on /20s off ,Duration : 25 minutes
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.
|
|
Aktiv komparator: Conventional therapy
Participants will receive conventional physiotherapy for upper limb rehabilitation following stroke, including standard exercises aimed at improving strength, range of motion, and functional ability.
|
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)
NMES applied to wrist extensors .Frequency: 35Hz ,Pulse Width250 ,Duty cycle :10s on /20s off ,Duration : 25 minutes
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fugl-Meyer Assesssment _Upper Extremity
Tidsram: 8th week
|
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
|
8th week
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Ashworth Scale (MAS)
Tidsram: 8th week
|
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
|
8th week
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Aruba Saeed, Riphah International University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
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Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
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Först inskickad som uppfyllde QC-kriterierna
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