Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-05 @ 6:39 PM
Study NCT ID:
NCT04932668
Status:
UNKNOWN
Last Update Posted:
2021-06-21
First Post:
2021-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 494181, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-13T22:39', 'hasProtocol': True}, {'date': '2020-04-01', 'size': 69618, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-12T07:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-12', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-12', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention Rate', 'timeFrame': '4 weeks', 'description': 'The proportion of patients who completed the program. Patient completed divided with patient recruited, expressed in percentage (%).'}, {'measure': 'Acceptability', 'timeFrame': '4 weeks', 'description': 'Acceptability as evaluated at the end of the intervention by brief structured questionnaire developed for this study using 5 point Likert scale with 1 (strongly agree) and 5 (strongly agree).'}], 'secondaryOutcomes': [{'measure': 'Clinical measurement of spasticity', 'timeFrame': '4 weeks (pre and post assessment)', 'description': 'Ankle dorsiflexor (gastroc) Modified Ashworth Scale (MAS) as measured in MAS grade 1, 1+, 2, 3, 4'}, {'measure': 'Clinical measurement of spasticity', 'timeFrame': '4 weeks (pre and post assessment)', 'description': 'Modified Tardieu Scale (R1 and R2 angle of ankle dorsiflexion)'}, {'measure': 'Ankle dorsiflexion muscle strength', 'timeFrame': '4 weeks (pre and post assessment)', 'description': 'Manual Muscle Testing as measured in 0-5 (with 0 no movement and 5 is the strongest)'}, {'measure': 'Functional Outcome', 'timeFrame': '4 weeks (pre and post assessment)', 'description': '10 meter walking test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spasticity as Sequela of Stroke']}, 'descriptionModule': {'briefSummary': 'Spasticity is a common complication post stroke. Post-stroke spasticity along with weakness and lack of coordination result in gait abnormalities and functional limitations. Recent treatment option include neuromuscular electric stimulation (NMES), a form of therapy that applies electrical currents to produce contraction of innervated muscle by depolarizing local motor nerves. Currently, there are wide varieties of NMES devices available commercially for consumer.\n\nThe main purpose of this study is to evaluate the feasibility and acceptability of a home-based NMES program on lower limb spasticity in patient with post-stroke more than 6 months and to assess the impact of the program. This is single arm prospective intervention study. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Post stroke (hemorrhagic or ischemic) with ankle plantarflexor (gastrocnemius and soleus) spasticity MAS 1+ to MAS 3,\n2. Post stroke more than 6 months,\n3. At least 18 years old,\n4. Able to ambulate 10 meter either independently or aided (single point stick or quadripod)\n5. Compliant to outpatient therapy.\n6. Minimal cognitive (MMSE\\> 24) and minimal sensory impairment,\n7. Stable neurological and medical condition\n\nExclusion Criteria:\n\n1. Introduction or changes in anti-spastic medication dose within 3 months or during study period,\n2. Receiving intervention for spasticity (eg BoNT or serial casting) within 3 months or during research period,\n3. New neurological condition/disease,\n4. Presence of contraindications to NMES, which is: Pregnancy, Malignancy, Presence of electronic implant eg cardiac pacemaker, cardioverter defibrillator, Uncontrolled seizure/epilepsy, Infected tissues/ tuberculosis or osteomyelitis, Impaired lower limb circulation/ DVT/ thrombophlebitis, Recent fracture or osteoporosis, Actively bleeding tissue or person with untreated hemorrhagic disorder, Damaged or skin diseases at the affected lower limb'}, 'identificationModule': {'nctId': 'NCT04932668', 'briefTitle': 'Home Based Electrical Stimulation on Post-stroke Lower Limb Tightness.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Feasibility and Impact of A Home-Based NMES Program on Post-Stroke Lower Limb Spasticity', 'orgStudyIdInfo': {'id': '2020427-8560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-based Electrical Stimulation Program for lower limb spasticity', 'description': 'Single arm prospective intervention study to assess the feasibility and impact of a home-based program. Patient will apply home-based NMES on their leg for 20 minutes, 5 days a week for 4 weeks. At the end of the study, an outcome measures will be assessed and patient will be required to answer a questionnaires on their experience.', 'interventionNames': ['Other: Feasibility and Impact of Home-based Electrical Stimulation Program']}], 'interventions': [{'name': 'Feasibility and Impact of Home-based Electrical Stimulation Program', 'type': 'OTHER', 'otherNames': ['Program'], 'description': 'Home-based NMES program on spastic leg. The NMES pre-programmed dosage (locked):\n\nNMES waveform is biphasic PC, Frequency 50Hz, pulse width 400µs, ON:OFF 10s:20s and current amplitude: individual maximum tolerated to achieve ankle dorsiflexion.', 'armGroupLabels': ['Home-based Electrical Stimulation Program for lower limb spasticity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Tze Yang Chung', 'role': 'CONTACT', 'email': 'chungty@ummc.edu.my', 'phone': '+60192226593'}], 'facility': 'University Malaya Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Tze Yang Chung', 'role': 'CONTACT', 'email': 'chungty@ummc.edu.my', 'phone': '+60192226593'}], 'overallOfficials': [{'name': 'Raja Nabila BT Raja Mohamed Anuar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Malaya Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor, Principal Investigator', 'investigatorFullName': 'Raja Nabila binti Raja Mohamed Anuar', 'investigatorAffiliation': 'University of Malaya'}}}}