- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07629908
Effects of Neuromuscular Electrical Stimulation With Neural Mobilization in Stroke Patients
Effects of Neuromuscular Electrical Stimulation Combined With Upper Limb Neural Mobilization on Hand Grip and Range of Motion in Post Stroke Patients
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Literature Review: In previous studies researcher compared Dynamic Neural Mobilization and Proprioceptive Neuromuscular Facilitation (PNF) in 30 sub-acute stroke patients, divided into two groups (15 each). Both groups received 30-minute sessions, 5 days/week for 4 weeks. Pre-test FMA-UE scores were 33.60±7.13 (Group A) vs. 32.60±9.85 (Group B), and grip strength 2.92±1.07 kg vs. 1.70±0.68 kg. Post-test scores improved to 41.00±7.07 and 5.12±2.03 kg (Group A), and 34.13±10.40 and 3.32±0.82 kg (Group B). Dynamic Neural Mobilization showed significantly better improvements in both outcomes.
A randomised controlled experiment with forty-three stroke patients who had hemiplegia in order to evaluate the impact of neural mobilisation in conjunction with shoulder control training,. The additional effect of neural mobilisation in stroke rehabilitation was supported by the treatment group's considerably higher improvements in upper limb motor function (FMA-UE) and shoulder pain (NRS) after four weeks when compared to the control group that received only shoulder training.
A qualitative review of 16 studies on neurodynamics in stroke patients, including 9 RCTs, 3 clinical trials, 3 systematic reviews, and 1 case study. Most studies reported that neurodynamics improved range of motion, flexibility, tone reduction, pain, nerve conduction, cortical activity, and post-stroke function. Only one RCT reported no effect on spasticity. Despite these benefits, the review concluded that evidence remains limited and more high-quality research is needed to validate neurodynamic techniques in stroke rehabilitation.
A case study of a 68-year-old male post-stroke patient with right-sided hemiparesis. The patient received Neuromuscular Electrical Stimulation combined with Proprioceptive Neuromuscular Facilitation (PNF) therapy for 4 sessions over 2 weeks. Post-treatment, improvements were noted in muscle strength and reduction of pain during passive flexion of the shoulder, elbow, and knee. The study concluded that Neuromuscular Electrical Stimulation and Proprioceptive Neuromuscular Facilitation (PNF) effectively promote muscle growth, strength, and pain relief in hemiparetic stroke patients.
A systematic review on the effectiveness of Neuromuscular Electrical Stimulation (NMES) for post-stroke spastic hemiparetic limbs. A total of 26 studies were screened, and 9 clinical studies were included (7 upper limb, 2 lower limb). Spasticity was assessed using Modified Ashworth Scale (MAS) and Electromyography. Most studies reported a decrease in spasticity lasting at least two weeks post-intervention. The authors concluded Neuromuscular Electrical Stimulation (NMES) is effective both alone or combined with physical therapy, while recommending further studies on Neuromuscular Electrical Stimulation (NMES) parameters.
A parallel two-arm open-label trial on 26 sub-acute stroke patients using an interactive grasp rehabilitation system (S2) combining smart objects, orthoses, and forearm Neuromuscular Electrical Stimulation (NMES). Participants were block-randomized into experimental (n=14) and control (n=12) groups, receiving 30-minute sessions over 27 sessions. In patients with ARAT scores <35 (n=11), the experimental group showed greater improvement (+14.9 points on ARAT; p=0.0494). The study confirmed the feasibility and effectiveness of enriched Neuromuscular Electrical Stimulation (NMES)-based grasp rehabilitation.
A case study on three first-incident stroke survivors in South Africa to assess the effects of activity-based Neuromuscular Electrical Stimulation (NMES) during short inpatient care. Patients received two 30-minute Neuromuscular Electrical Stimulation (NMES) sessions daily along with occupational therapy for five days. Significant improvements were observed in motor function (FMA, p=0.002) and activities of daily living (MBI, p<0.001), particularly in toilet transfer, hygiene, and washing. Better cognitive function (MMSE scores) was associated with greater outcomes, while age and dominance had less impact.
A randomized controlled trial on 20 tetraplegic patients with upper limb spasticity (C5-C8 level). Participants were randomized into neurodynamic mobilization (n=11) and conventional therapy (n=9) groups, receiving treatment 5 days/week for 4 weeks. Neurodynamic mobilization showed significant improvements: MAS for wrist flexors (-1.64±0.67), finger flexors (-1.00±0.63), F-wave amplitude (-154.09±220.86), F/M ratio (-0.18±0.24), and CUE scores (+17.82±13.49), indicating reduced spasticity and improved upper limb function.
A randomized controlled trial evaluating the effects of neuromuscular electrical stimulation combined with mirror therapy. They reported significant improvements in hand function, motor control, and cortical excitability compared to conventional therapy alone in chronic stroke patients.
In a review of innovative neurotechnologies, that the effect of neuromuscular electrical stimulation (NMES) in regaining motor function following a stroke. According to the study, Neuromuscular Electrical Stimulation (NMES) enhances muscle strength and neuroplasticity, especially when paired with voluntary movement and task-specific training. The authors also go over the advantages of combining Neuromuscular Electrical Stimulation (NMES) with closed-loop systems and brain-machine interfaces to improve the accuracy and results of motor rehabilitation.
A systematic review to assess the status of peripheral neural mechanics and the effect of neural mobilization in stroke rehabilitation. The search across multiple databases identified 22 studies, out of which 12 were included (7 RCTs, 3 quasi-experimental, 1 case report, 1 systematic review). Most studies reported positive therapeutic benefits of neural mobilization, but due to limited methodological quality, the evidence remains weak. The review emphasized the need for further high-quality research on neural mobilization in stroke patients.
Study Gap: Despite the proven benefits of Neuromuscular Electrical Stimulation and neural mobilization in stroke rehabilitation, current literature largely examines these interventions in isolation. To date, up to the researcher's knowledge, no study has directly assessed the combined effects of Neuromuscular Electrical Stimulation and neural mobilization on hand grip strength and upper limb function in post-stroke patients. Additionally, there is limited evidence on standardized protocols for their integration in upper limb rehabilitation.
Given that Neuromuscular Electrical Stimulation targets muscle activation and neural mobilization addresses nerve mobility, combining both may produce synergistic improvements in motor function of upper limb and hand grip. This study aims to fill this gap by evaluating the effectiveness of a combined approach, providing evidence-based strategies for optimizing stroke rehabilitation outcomes.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Imran Amjad, PhD
- Telefonní číslo: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Diagnosed with ischemic stroke (duration ≥ 3 months post-stroke)
- Patients with hemiparesis affecting the upper limb have a 15-30 score by the Fugl-Meyer Assessment.
- Medically stable for physical therapy
- Signed informed consent
Exclusion Criteria:
- Patients with pacemakers or implanted electrical devices
- Upper limb fractures or contractures
- Skin allergies or wounds over the stimulation site
- Previously taking physiotherapy for the last 3 months.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Control group
Participants in the control group received neural mobilization in combination with conventional physical therapy.
Conventional rehabilitation consisted of standardized upper limb exercises, including ROM activities, strengthening exercises, stretching and task oriented training.
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Neural mobilization for median, radial, and ulnar nerves. 3 sets of 10 repetitions per nerve for 15 mins with 30 sec rest. Progressed based on tolerance and Range of Motion. Conventional rehabilitation consisted of standardized upper limb exercises, including ROM activities, strengthening exercises, stretching and tsk oriented training. Each treatment session was conducted for 45 minutes.
Ostatní jména:
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Experimentální: Experimental group
Participants in the experimental group received neuromuscular electrical stimulation combined with upper limb neural mobilization.
NMES was administrated using a frequency range of 35-50 Hz and a pulse duration of 250-300 µsec, with an on-off ratio of 1:3.
The stimulation intensity was gradually increased until a visible muscle contraction was achieved.
Neural mobilization was performed using standardized techniques targeting the median, radial and ulnar nerves.
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Neuromuscular Electrical Stimulation (NMES) applied to wrist extensors and finger flexors. Frequency: 35 Hz. Pulse width: 250 µs. Duty cycle: 10s on / 20s off. Intensity: Visible muscle contraction, within patient tolerance. Duration: 30 min Neuromuscular Electrical Stimulation (NMES) + 15 min rest/cool-down. Neural mobilization for median, radial, and ulnar nerves. 3 sets of 10 repetitions per nerve with 30 sec rest.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Handheld dynamometer
Časové okno: Baseline and 6th week
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The standard Jamar hydraulic handgrip dynamometer with reliability (ICC = 0.95-0.98)
was used according to established ASHT (American Society of Hand Therapists) protocols for the measurement of hand grip strength.
The patient was seated with shoulder adducted, elbow flexed at 90°, forearm neutral, and wrist 0-30° extension.
A total of three trials (kg) with a 1-minute rest between trials was done, and the mean of the 3 values was recorded.
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Baseline and 6th week
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Goniometer
Časové okno: baseline and 6th week
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A clinically accepted instrument with high reliability (ICC: 0.85 - 0.99), in accordance with standardised assessment protocols.
Each movement was measured across three trails with a 1-minute rest period between trails, and the average of the three readings (in degrees) was used for statistical analysis.
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baseline and 6th week
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Fugl-Meyer Assessment - Upper Extremity
Časové okno: Baseline and 6th week
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The scale assesses motor recovery by observing movement patterns that advance from proximal to distal joints and from mass synergistic actions to more selective, isolated movements following a stroke.
It consists of 4 sections: shoulder-arm, wrist, hand, and coordination and speed.
It comprises 33 test items, each scored on a three-point ordinal scale (0-2) with a maximum achievable score of 66.
In stroke patients the scale has revealed high reliability (ICC: 0.993 - 0.997).
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Baseline and 6th week
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Hira Jabeen, Riphah International University
- Vrchní vyšetřovatel: Jabeen, Riphah International University
Publikace a užitečné odkazy
Obecné publikace
- Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.
- Baradie RSA. Neurodynamics and mobilization in Stroke Rehabilitation- A Systematic Review. Majmaah Journal of Health Sciences. 2020;5(2).
- Micera S, Caleo M, Chisari C, Hummel FC, Pedrocchi A. Advanced Neurotechnologies for the Restoration of Motor Function. Neuron. 2020 Feb 19;105(4):604-620. doi: 10.1016/j.neuron.2020.01.039.
- Eschle S, Hartmann K, Rieger A, Fischer S, Klima A, Bergmann M. Canine vaccination in Germany: A survey of owner attitudes and compliance. PLoS One. 2020 Aug 27;15(8):e0238371. doi: 10.1371/journal.pone.0238371. eCollection 2020.
- Saxena A, Sehgal S, Jangra MK. Effectiveness of Neurodynamic Mobilization versus Conventional Therapy on Spasticity Reduction and Upper Limb Function in Tetraplegic Patients. Asian Spine J. 2021 Aug;15(4):498-503. doi: 10.31616/asj.2020.0146. Epub 2020 Oct 19.
- Badenhorst. A CASE STUDY TO DETERMINE THE EFFECT OF AN ACTIVITY-BASED NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) PROGRAMME. 2020.
- Crema A, Furfaro I, Raschella F, Rossini M, Zajc J, Wiesener C, Baccinelli W, Proserpio D, Augsten A, Immick N, Becker S, Weber M, Schauer T, Krakow K, Gasperini G, Molteni F, Russold MF, Bulgheroni M, Micera S. Reactive Exercises with Interactive Objects: Interim Analysis of a Randomized Trial on Task-Driven NMES Grasp Rehabilitation for Subacute and Early Chronic Stroke Patients. Sensors (Basel). 2021 Oct 11;21(20):6739. doi: 10.3390/s21206739.
- Chodijah S. THE EFFECT OF NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) AND PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION (PNF) IN INCREASING EXTREMITY MUSCLE STRENGTH OF HEMIPARESIS DEXTRA PATIENT: A CASE STUDY. Academic Physiotherapy Conference Proceeding. 2022;1.
- HU Y. Effect of neural mobilization based on shoulder control training on shoulder pain and upper limb function in stroke patients with hemiplegia. Chinese Journal of Rehabilitation Theory and Practice. 2024;2.
- Selvaraj. Dynamic Neural Mobilization Versus Proprioceptive Neuromuscular Facilitation on Grip Strength and UpperLimb Function in Sub-Acute Stroke Subjects. Indian Journal of Physiotherapy & Occupational Therapy. 2025;19(1)
- Zamurd D, Baig M. Neurodynamics for motor recovery after Stroke, a Review Article. 2023;17:1008.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Termíny související s touto studií
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