Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT07147933
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Treatment on Cerebral Palsy Patient With Crouch Gait Associated With Anterior Pelvic Tilt and Soleus Muscle Weakness"Marouf Syndrome", and Muscle Assesment by Using EMG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '(single blind) the Outcomes Assessor who was unaware to the approach of treatment that would be executed to the children into two groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized controlled trial designed using a parallel assignment model. Participants will be randomly divided into two groups. One group will receive the physical therapy intervention being studied, while the other group will receive tradtional physical therapy protocol. The aim is to compare the effects of the intervention by measuring muscle activity using surface electromyography (sEMG) before and after the treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EMG and we calculate RMS for soleus muscle', 'timeFrame': 'the primary outcome measures by using EMG before treatment paln and after 8 weeks'}], 'secondaryOutcomes': [{'measure': 'step length', 'timeFrame': 'before treatment plan and after 8 weeks'}, {'measure': 'step wedth', 'timeFrame': 'before treatment plan and after 8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy (CP)', 'Diaplegia', 'Muscle Weakness | Patient', 'Anterior Pelvic Tilt', 'Crouch Gait']}, 'descriptionModule': {'briefSummary': 'Children with cerebral palsy (CP) often develop gait abnormalities, with crouch gait being a common and challenging issue that affects their posture and daily function. Numerous studies indicate that crouch gait is primarily caused by hamstring tightness and quadriceps weakness. Traditional treatment approaches focus on hamstring stretching and quadriceps strengthening exercises to improve gait patterns. highlight the importance of strengthening muscles like the quadriceps and stretching tight muscles such as the hamstrings in improving gait abnormalities source.\n\nDespite these common treatments, results often fall short of achieving full correction of crouch gait. Therefore, I propose a novel approach to treating abnormal gait in children with CP by targeting the anterior pelvic tilt and strengthening the soleus muscle. This approach aims to address biomechanical factors that are not typically considered in traditional treatments, potentially leading to better functional outcomes\n\nwe use Surface EMG to record activity of key muscle (soleus) during Seated Calf Raises exercise Muscle activity will be recorded before and after a series of physical therapy sessions focused on pelvic alignment and soleus strengthening.\n\nEMG Data Analysis: Root Mean Square (RMS), timing of activation, and amplitude changes will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\npatient with cp have a crouch gait. ages from 4 to 10 years . have a anterior pelvic tilt . muscle weakness (Soleus) on EMG.\n\n* BMI from 18.5 to 21..\n* didn't submit to Selective Dorsal Rhizotomy surgery.\n\nExclusion Criteria:\n\nhave a posterior pelvic tilt.\n\n-above 10 or below 4 years. not able to walk. . submitted to SDR surgery. BMI above 21 or below 18.5."}, 'identificationModule': {'nctId': 'NCT07147933', 'briefTitle': 'Effect of Treatment on Cerebral Palsy Patient With Crouch Gait Associated With Anterior Pelvic Tilt and Soleus Muscle Weakness"Marouf Syndrome", and Muscle Assesment by Using EMG', 'organization': {'class': 'OTHER', 'fullName': 'Philadelphia University, Jordan'}, 'officialTitle': 'Physical Therapy Protocol for Crouch Gait Associated to the Anterior Pelvic Tilt and Soleus Muscle Weakness in CP Patient', 'orgStudyIdInfo': {'id': '2/5/2024-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'A targeted physical therapy program including correction of anterior pelvic tilt, strengthening of the soleus, core strengthening, stretching of the hamstrings, and strengthening of the quadriceps. The program will be delivered 3 times per week for 8 weeks under therapist supervision.', 'interventionNames': ['Other: phusical therapy program', 'Other: physical therapy program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'physical therapy program including stretching of the hamstrings and strengthening of the quadriceps only. The program will be delivered 3 times per week for 8 weeks under therapist supervision', 'interventionNames': ['Other: phusical therapy program', 'Other: physical therapy program']}], 'interventions': [{'name': 'phusical therapy program', 'type': 'OTHER', 'description': 'physical therapy program including stretching of the hamstrings and strengthening of the quadriceps only. The program will be delivered 3 times per week for 8 weeks under therapist supervisio', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'physical therapy program', 'type': 'OTHER', 'description': 'A targeted physical therapy program including correction of anterior pelvic tilt, strengthening of the soleus, core strengthening, stretching of the hamstrings, and strengthening of the quadriceps. The program will be delivered 3 times per week for 8 weeks under therapist supervision.', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amman', 'status': 'RECRUITING', 'country': 'Jordan', 'contacts': [{'name': "Ahmed Yasser Mostafa Marouf, Bachelor's of Physical Therapy", 'role': 'CONTACT', 'email': 'ahmedmarouf00@icloud.com', 'phone': '01026913232'}], 'facility': 'Queen Rania AL Abdullah hospital for children', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}], 'centralContacts': [{'name': "Ahmed Yasser Mostafa Marouf, bachelor's physical thrapy", 'role': 'CONTACT', 'email': 'ahmedmarouf00@icloud.com', 'phone': '+201026913232'}], 'overallOfficials': [{'name': "Ahmed Yasser Mostafa Marouf, bachelor's physical thrapy", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Bachelor's of Physical Therapy, Faculty of Allied Medical Sciences, Philadelphia University, Amman"}, {'name': "Rovan Ayman Hassan Hamlet, bachelor's physical thrapy", 'role': 'STUDY_DIRECTOR', 'affiliation': "Rovan Ayman Hassan Mohamed Hamlet Bachelor's of physical therapy, Delta university"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philadelphia University, Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physical therapist (BSc PT)', 'investigatorFullName': 'Ahmed Yasser Mostafa Marouf', 'investigatorAffiliation': 'Philadelphia University, Jordan'}}}}