Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-22 @ 4:11 AM
Study NCT ID:
NCT04820660
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': '4months', 'description': 'Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.'}, {'measure': 'Fugl Meyer Assessment Lower Extremity', 'timeFrame': '4 months', 'description': 'Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'progressive resistance strength training'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '21571152', 'type': 'BACKGROUND', 'citation': 'Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.'}, {'pmid': '7477192', 'type': 'BACKGROUND', 'citation': 'National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.'}, {'pmid': '17687132', 'type': 'BACKGROUND', 'citation': 'van der Worp HB, van Gijn J. Clinical practice. Acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):572-9. doi: 10.1056/NEJMcp072057. No abstract available.'}, {'pmid': '19359645', 'type': 'BACKGROUND', 'citation': 'Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009 Jun;40(6):2068-72. doi: 10.1161/STROKEAHA.108.540112. Epub 2009 Apr 9.'}, {'pmid': '12444191', 'type': 'BACKGROUND', 'citation': 'Albers GW, Caplan LR, Easton JD, Fayad PB, Mohr JP, Saver JL, Sherman DG; TIA Working Group. Transient ischemic attack--proposal for a new definition. N Engl J Med. 2002 Nov 21;347(21):1713-6. doi: 10.1056/NEJMsb020987. No abstract available.'}, {'pmid': '12855835', 'type': 'BACKGROUND', 'citation': 'Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'Stroke is ranked as the number fifth cause of death and a main cause of disability in the United States. It affects the arteries which supply blood to and within the brain. If the blood supply to the brain is disrupted, it will not be able to receive oxygen and the nutrients which are transported by those arteries. This leads to the death of brain cells having a magnificent effect on the function of that part.', 'detailedDescription': 'This study was quasi-experimental trial, to compare the effectiveness of Progressive Resistive Strength Exercises and Balance Exercises in subjects with Stroke. Subjects with Stroke meeting the predetermined inclusion \\& exclusion criteria were divided into two groups using lottery method. Pre assessment was done using Berg Balance Scale, Fugl Meyer Assessment - Lower Extremity and Step Test.\n\nSubjects in one group were treated with Progressive Resistive Strength Training and other group was treated with Balance training. Each subject received 12 treatment sessions, with 03 treatment sessions per week. Results were recorded at the end of 3rd, 6th, 9th and 12th treatment sessions. Recorded values were analysed using SPSS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiparetic from a single stroke occurring at least a year earlier, not presently receiving any rehabilitation services,\n* Participants should not be receiving any rehabilitation services\n* Participants should be able to walk 10 m independently without an assistive device\n* Participants should be medically stable enough to allow participation, and able to understand instructions and follow commands.\n\nExclusion Criteria:\n\n* Participants with any medical condition that would prevent participation in the training program\n* Participants with any uncontrolled health condition for which exercise is contraindicated.\n* Participants with any tumor or neurological signs.'}, 'identificationModule': {'nctId': 'NCT04820660', 'briefTitle': 'Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Task-oriented Progressive Resistance Strength Training and Balance Exercises in Functional Performance on Lower Limb in Individuals With Stroke', 'orgStudyIdInfo': {'id': 'REC/Lhr/19/2033 Hira Javed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Task oriented Strength training group', 'description': 'Standing and reaching in different directions Sit-to-stand Stepping forward and backward Stepping sideways onto blocks', 'interventionNames': ['Other: Task orientated strengthening training']}, {'type': 'EXPERIMENTAL', 'label': 'Balance Training', 'description': 'Stepping forward, backward, and sideways on the exercise step; Stepping over blocks of various heights; Standing up from a chair, From a sitting position on a 65-cm Swiss ball, Arms; bending the trunk forward and side to side); Performing double-legged stance Performing tandem stance Rising from a chair without the use of the arms; Walking forward and backward with a tandem walking pattern Performing single- legged stance', 'interventionNames': ['Other: Balance training exercises']}], 'interventions': [{'name': 'Task orientated strengthening training', 'type': 'OTHER', 'description': "1. Standing and reaching in different directions for objects located beyond arm's length to promote loading of the lower limbs and activation of lower limb muscles;\n2. Sit-to-stand from various chair heights to strengthen the lower limb extensor muscles;\n3. Stepping forward and backward onto blocks of various heights to strengthen the lower limb muscles;\n4. Stepping sideways onto blocks of various heights to strengthen the lower limb muscles;\n5. forward step-up onto blocks of various heights to strengthen the lower limb muscles;\n6. heel(s) raise and lower while maintaining in a standing posture to strengthen the plantar- flexor muscles.\n\nEach workstation was 5 min in duration for each exercise class. Each subject participated in a one-to-one therapy.", 'armGroupLabels': ['Task oriented Strength training group']}, {'name': 'Balance training exercises', 'type': 'OTHER', 'description': '1. Stepping forward, backward, and sideways on the exercise step;\n2. Stepping over blocks of various heights;\n3. Standing up from a chair, walking four steps forward, performing a bilateral stool touch and walking backwards to the chair;\n4. Standing up from a chair, walking four steps forward, turning to the right, stepping over the exercise step, turning to the right again and walking forwards to the chair (repeat the exercise circuit in opposite direction);\n5. From a sitting position on a 65-cm Swiss ball, performing a range of motion and balance exercises (forward and backward rolling of the\n6. Arms; bending the trunk forward and side to side);\n7. Performing double-legged stance for 10 s;\n8. Performing tandem stance for 10 s;\n9. Rising from a chair without the use of the arms;\n10. Walking forward and backward with a tandem walking pattern (toes of one foot touching the heel of the foot in front);\n11. Performing single- legged stance for 10 s.', 'armGroupLabels': ['Balance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Riphah IU', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Rabiya Noor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}