Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients

This single-blinded randomized controlled trial will be conducted at the Physical Therapy Department of the University of Lahore Teaching Hospital after approval from the Institute Research Ethics Board. Eligible participants will be recruited and randomly allocated into two groups by lottery method: Group A (control group) receiving conventional physical therapy, and Group B (experimental group) receiving neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction. NEMS will be applied to the tibialis anterior, extensor hallucis longus, and extensor digitorum longus with standard stimulation parameters, while participants perform active dorsiflexion during stimulation. The assessor will remain blinded to group allocation. Outcome measures including spasticity (Modified Ashworth Scale), active range of motion (goniometer), and muscle strength (manual muscle testing) will be evaluated at baseline, 6 weeks, and 12 weeks.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Conventional physiotherapy; Other: Neuromuscular electrical stimulation and voluntary muscle contraction

Detailed Description

Recruitment: Participants will be recruited from Physical Therapy Department of University of Lahore Teaching Hospital, Lahore Screening: All the referred participants will be assessed for the eligibility criteria.

Patients fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to the study. Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group/NEMS + voluntary muscle contraction group. Group B: control group/standard rehabilitation therapy) by lottery method. Blinding: This study was a single blinded study in which assessor was kept blinded Intervention Group A: Comparative Group (Conventional physical therapy) Patients in comparative group will receive conventional approach that will encompass placebo effect application of NEMS, weight bearing , stretching , pnf technique , tapping , passive roms , strength exercise of dorsiflexors Group B : Experiment Group/NEMS+Voluntary muscle contraction group: The participants randomly allocated in Group A will receive the electrical stimulation through electrodes on tibialis anterior, extensor hallucis longus and extensor digitorum longus

.Stimulation parameters will be as follows: pulse width=200 microseconds; on time=5seconds; off time=5seconds; frequency=20Hz; waveform=symmetrical biphasic square wave. The patient will be instructed to produce a voluntary dorsi flexors contraction with the electric pulse The stimulation intensity will adjusted according to each treatment group. All intensities were comfortable for the patients and did not induce fatigue. Any complaints and discomfort during the treatment process in each group will monitored and recorded using a patient record.

Outcome Variables:

1. Spasticity: Modified Ashworth scale
2. Active rom: Goniometer
3. Muscle Grading: Manual muscle testing Data will be assessed by assessor at baseline, at the end of 6th week and at the end of 12th week

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age of between 43 to 83 years of age
• Diagnosed with chronic stroke (≥6 months in duration) with motor deficits resulting in hemiplegia
• Mild ankle dorsiflexion possible
• MAS score of ≤3 for dorsiflexors to the ankle joint
• Be self-mobility either with or without aids .

Exclusion Criteria:

• Parkinson's or multiple sclerosis affecting the nervous systems of the body
• Skeletal disorders that hinder the ability of the limb
• Pacemaker or any condition which may lead to a contraindication with NMES
• Spasticity (MAS ≥ 3)
• Current botulinum toxin injections in the lower limb that developed the spasticity
• Patients with any cognitive impairment (MMSE < 24)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional physiotherapy; Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.	Other: Conventional physiotherapy; Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.; Other: Neuromuscular electrical stimulation and voluntary muscle contraction; Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction; Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient.
Experimental: Neuromuscular electrical stimulation + Voluntary muscle contraction; Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient	Other: Conventional physiotherapy; Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.; Other: Neuromuscular electrical stimulation and voluntary muscle contraction; Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction; Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth scale	The Modified Ashworth Scale is a clinical tool used to assess muscle spasticity by measuring resistance during passive soft-tissue stretching. It grades the increase in muscle tone on a scale from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. It is a widely used and reliable method for evaluating the severity of spasticity in patients with neurological or musculoskeletal conditions.	12 weeks
Goniometery	A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.	12 weeks
Manual muscle testing	Manual Muscle Testing is a standardized clinical assessment used to evaluate the strength of individual muscles or muscle groups based on the examiner's application of resistance. Muscle strength is graded on a six-point scale (0-5), where 0 indicates no muscle contraction and 5 represents normal strength against full resistance. It is a reliable and widely used method to assess motor function, recovery, and the effectiveness of therapeutic interventions.	12 weeks

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: Abdul Moiz Hussain Khan, Mspt- neuro, University of Lahore

Publications and helpful links

General Publications

• Gillard, J. H., Parrish, T. B., & Mossa-Basha, M. (2021). Stroke imaging advancements. Neuroimaging Clinics of North America, 31(1), 1-17. https://doi.org/10.1016/j.nicna.2020.11.001
• Fugl-Meyer, A. R., Jääskö, L., Leyman, I., Olsson, S., & Steglind, S. (1975). The post- stroke hemiplegic patient: A method for evaluation of physical performance. Scandinavian Journal of Rehabilitation Medicine, 7(1), 13-31.
• Feigin, V. L., Norrving, B., & Mensah, G. A. (2017). Global burden of stroke. The Lancet Neurology, 16(11), 877-897. https://doi.org/10.1016/S1474-4422(17)30283-0
• Doucet, B. M., Lam, A., & Griffin, L. (2012). Neuromuscular electrical stimulation for skeletal muscle function. Yale Journal of Biology and Medicine, 85(2), 201-215.
• Chen, H., Lin, Y., Chen, C., & Tang, Y. (2022). NMES and VMC for dorsiflexion and mobility improvements in chronic stroke. Journal of Neurorehabilitation, 29(6), 378- 387. https://doi.org/10.1016/j.neurorehab.2022.05.004
• Busk H, Skou ST, Lyckhage LF, Arens CH, Asgari N, Wienecke T. Neuromuscular Electric Stimulation in Addition to Exercise Therapy in Patients with Lower Extremity Paresis Due to Acute Ischemic Stroke: A proof-of-concept randomised controlled trial. J Stroke Cerebrovasc Dis. 2021 Oct;30(10):106050. doi: 10.1016/j.jstrokecerebrovasdis.2021.106050
• Burridge, J., Wood, D., Taylor, P., & Swain, I. (2014). Feasibility study on NMES and VMC for dorsiflexion recovery. Archives of Physical Medicine and Rehabilitation, 95(4), 817-824. https://doi.org/10.1016/j.apmr.2013.12.011
• Bohannon, R. W., & Smith, M. B. (1987). Interrater reliability of a modified Ashworth scale of muscle spasticity. Physical Therapy, 67(2), 206-207. https://doi.org/10.1093/ptj/67.2.206
• ● Benjamin, E. J., Muntner, P., Alonso, A., Bittencourt, M. S., Callaway, C. W., Carson, A. P., ... & Virani, S. S. (2019). Heart disease and stroke statistics-2019 update: A report from the American Heart Association. Circulation, 139(10), e56-e528. https://doi.org/10.1161/CIR.0000000000000659
• Ahmed, A., et al. (2019). Evaluation of NMES and VMC for ankle control in chronic stroke. Journal of Stroke and Cerebrovascular Diseases, 28(12), 3417-3425.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Hemiplegia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemiplegia
• Other Study ID Numbers: UOL/IREB/25/12/0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No