Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:40 AM
Study NCT ID:
NCT07458750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Ashworth scale', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Goniometery', 'timeFrame': '12 weeks', 'description': 'A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.'}, {'measure': 'Manual muscle testing', 'timeFrame': '12 weeks', 'description': "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."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemiplegia'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '● 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'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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\n\n.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.\n\nOutcome Variables:\n\n1. Spasticity: Modified Ashworth scale\n2. Active rom: Goniometer\n3. 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '83 Years', 'minimumAge': '43 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\- Age of between 43 to 83 years of age .\n2. .Diagnosed with chronic stroke (≥6 months in duration) with motor deficits resulting in hemiplegia. 3. Mild ankle dorsiflexion possible. 4. MAS score of ≤3 for dorsiflexors to the ankle joint . 5. Be self-mobility either with or without aids .\n\nExclusion Criteria:\n\n1\\. Parkinson's or multiple sclerosis affecting the nervous systems of the body .\n\n2 .Skeletal disorders that hinder the ability of the limb . 3. Pacemaker or any condition which may lead to a contraindication with NMES 4. Spasticity (MAS ≥ 3). 5 .Current botulinum toxin injections in the lower limb that developed the spasticity .\n\n6\\. Patients with any cognitive impairment (MMSE \\< 24) ."}, 'identificationModule': {'nctId': 'NCT07458750', 'briefTitle': 'Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Neuromuscular Electrical Stimulation and Voluntary Muscle Contraction in Chronic Hemiplegic Stroke Patients', 'orgStudyIdInfo': {'id': 'UOL/IREB/25/12/0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional physiotherapy', 'description': "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.", 'interventionNames': ['Other: Conventional physiotherapy', 'Other: Neuromuscular electrical stimulation and voluntary muscle contraction']}, {'type': 'EXPERIMENTAL', 'label': 'Neuromuscular electrical stimulation + Voluntary muscle contraction', 'description': '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', 'interventionNames': ['Other: Conventional physiotherapy', 'Other: Neuromuscular electrical stimulation and voluntary muscle contraction']}], 'interventions': [{'name': 'Conventional physiotherapy', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Conventional physiotherapy', 'Neuromuscular electrical stimulation + Voluntary muscle contraction']}, {'name': 'Neuromuscular electrical stimulation and voluntary muscle contraction', 'type': 'OTHER', 'description': 'Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction\\<br\\>\\<br\\>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.', 'armGroupLabels': ['Conventional physiotherapy', 'Neuromuscular electrical stimulation + Voluntary muscle contraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'University of lahore teaching hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Abdul Moiz Hussain Khan, Mspt- neuro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}