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Effects of Neuromuscular Electrical Stimulation With Neural Mobilization in Stroke Patients

R

Riphah International University

Status

Not yet enrolling

Conditions

Stroke
Post Stroke Hand Rehabilitation

Treatments

Other: Neuromuscular Electrical Stimulation
Other: Conventional physical therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07629908
REC/0235 Fatima Shahid

Details and patient eligibility

About

The goal of this clinical trial is to learn if neuromuscular electrical stimulation combined with upper limb neural mobilization works to improve hand grip and upper limb function in post-stroke patients.

Full description

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.

Enrollment

44 estimated patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Control group
Active Comparator group
Description:
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.
Treatment:
Other: Conventional physical therapy
Experimental group
Experimental group
Description:
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.
Treatment:
Other: Neuromuscular Electrical Stimulation

Trial contacts and locations

0

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Central trial contact

Imran Amjad, Phd

Data sourced from clinicaltrials.gov

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