Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-03-28 @ 11:35 PM
Study NCT ID:
NCT04459832
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Duration of Stretching of the Hamstring Muscle Group in Elderly: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "The assessor, who took the measurements for both the intervention and control groups, was blinded to the subject's group, while the treating therapist was not blinded to the treatment intervention."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial study 100 participants will be recruited to participate in the study after assigning a conset form, participants will be divided into 4 group ,one control which will not receive stretch of hamstring and 3 experimental groups will recive different duration for hamstring stretch 15,30,60 and DSSEP will be measured as the primary outcome and knee ROM will be measured as a secondary outcomes in order to identify the optimal duration of hamstring stretch'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurophysiological findings.', 'timeFrame': 'Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session', 'description': 'Neurophysiological findings included peak to peak somatosensory evoked potentials (DSSEPs) for L3,L4,L5,S1 dermatomes.'}], 'secondaryOutcomes': [{'measure': 'ROM', 'timeFrame': 'Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session', 'description': 'Each subject was then measured for knee extension ROM on both lower extremities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stretching', 'Randomized controlled trial', 'Hamstring'], 'conditions': ['Stretch']}, 'descriptionModule': {'briefSummary': 'identification of optimal duration for hamstring muscle stretch by using 3 different time of stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4 group one control and 3 experimental groups according to stretch time.', 'detailedDescription': 'Abstract:\n\nOBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.\n\nDESIGN: Randomized controlled trial Participants: In this trial, 100 participants will participate in the study diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups will stretched 5 times per week for 4 weeks for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures will be assessed immediately after the treatment session and 24 hours after the treatment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects had to demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects were also screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position\n\nExclusion Criteria:\n\n* Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study'}, 'identificationModule': {'nctId': 'NCT04459832', 'briefTitle': 'Optimal Duration of Stretching of the Hamstring Muscle Group in Elderly: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Optimal Time of Hamstring Stretch in Elderly', 'orgStudyIdInfo': {'id': 'A Randomized Controlled Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 second stretch', 'description': 'Stretching of the hamstring muscles was performed by the primary researcher for 15 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible', 'interventionNames': ['Procedure: stretch hamstring']}, {'type': 'EXPERIMENTAL', 'label': '30 second stretch', 'description': 'Stretching of the hamstring muscles was performed by the primary researcher for 30 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible', 'interventionNames': ['Procedure: stretch hamstring']}, {'type': 'EXPERIMENTAL', 'label': '60 second stretch', 'description': 'Stretching of the hamstring muscles was performed by the primary researcher for 60 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible', 'interventionNames': ['Procedure: stretch hamstring']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'The control group followed the same procedures except that no stretching force was applied at the end', 'interventionNames': ['Procedure: stretch hamstring']}], 'interventions': [{'name': 'stretch hamstring', 'type': 'PROCEDURE', 'description': 'Stretching of the hamstring muscles was performed by the primary researcher. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible', 'armGroupLabels': ['15 second stretch', '30 second stretch', '60 second stretch', 'control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical therapy', 'investigatorFullName': 'Shimaa Taha Abu El Kasem', 'investigatorAffiliation': 'Cairo University'}}}}