Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-28 @ 10:52 PM
Study NCT ID:
NCT06598657
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Talocrural Mobilization With Movement in Spastic Cerebral Palsy
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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Up and Go', 'timeFrame': '4 weeks', 'description': 'In the TUG test, a child begins in a seated position on a chair or other designated surface. They are instructed to stand up, walk a specific distance (usually three meters or ten feet), turn around, and return to the seated position. The time taken to complete the task is recorded. Evaluation is made by comparing pre and post-intervention. To assess mobility of patient.'}, {'measure': '10 m WALK TEST', 'timeFrame': '4 weeks', 'description': 'The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility and gait. Stopwatch is used and the total time taken to ambulate 6 meters is recorded. Timing starts when the toes pass the 2-meter mark. Timing stops when the toes pass the 8-meter mark. The 6m is then divided by the total time taken (in seconds) to completed. The total time is recorded in m/s'}, {'measure': 'Goniometer', 'timeFrame': '4 weeks', 'description': 'It is an instrument that measures the available range of motion at a joint.'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': '4 weeks', 'description': 'Modified Ashworth Scale (MAS) is used to assess spasticity. Different grades from 0 to 4 are used to access increased tone and spasticity. With 0 referring to "No increase in tone" and 4 refers to "Affected part rigid in flexion/extension" The measurements are recorded at baseline, during treatment and after treatment protocol.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Talocrural joint', 'Mobilization with Movement', 'Spasticity cerebral palsy'], 'conditions': ['Spastic Cerebral Palsy (sCP)']}, 'descriptionModule': {'briefSummary': "The aim of this randomized controlled trial is to find the effect of Mulligan's Mobilization with Movement of Talocrural joint in Cerebral Palsy Patients having spasticity on improving Ankle Range of Motion, improving balance and its effect on Gait speed.", 'detailedDescription': "Cerebral palsy is a neurodevelopmental disorder involving abnormalities in muscle tone and motor function due to damaged cerebral tissue in development. It is a nonprogressive upper motor neuron lesion characterized by abnormal tone, posture, balance and movement and clinically classified based on the predominant motor syndrome. In spastic CP, there is significant weakness that contributes to abnormal posture and movement. This is also accompanied by decreased muscle endurance and loss of selective motor control (SMC). Spastic diplegia is a very common form of CP, with a wide range of ambulatory outcomes, and is most frequently accompanied by ankle spasticity. Abnormalities, such as excessive plantar flexion of the ankle, leads to individuals with CP have in both static and dynamic balance.\n\nJoint mobilization has not only the mechanical effect of disrupting the contracture by direct movement of the joint area, but also stimulates mechanoreceptor activation when stretching occurs in the capsule and ankle ligaments.\n\nThe Mulligan Mobilization with movement (MWM) is a physical therapy technique that combines joint mobilization techniques with active movement. It aims to improve joint range of motion, reduce stiffness, and enhance functional mobility, is expected to produce an instantaneous improvement in the patient's abilities by simultaneous applying of pain-free accessory glides.\n\nThis study will contribute in describing long lasting effects of Mobilization With Movement, with multiple assessments, on ankle range of motion, balance, and gait speed, and to check whether the amount of regaining is similar between patients undergoing MWM with conventional therapy and those with conventional therapy alone"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Both genders\n* Age group 8-18 years\n* Diagnosis of spastic Cerebral Palsy\n* CP to follow verbal directions\n* Modified Ashworth Scale score of '1' or '1+'\n* Function classification system (GMFCS) level I or II ability to walk\n* 10 m or more independently\n\nExclusion Criteria:\n\n* visual, hearing disorders\n* verbal and cognitive disorders (unable to comprehend commands)\n* recent lower extremity surgery\n* botulinum toxin injection"}, 'identificationModule': {'nctId': 'NCT06598657', 'briefTitle': 'Talocrural Mobilization With Movement in Spastic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Talocrural Joint Mobilization With Movement in Spastic Cerebral Palsy Patients', 'orgStudyIdInfo': {'id': 'REC/01877 Maimoona Mubarik'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mobilization with Movement MWM of Talocrural joint + Conventional PT', 'interventionNames': ['Other: Mobilization with Movement MWM']}, {'type': 'OTHER', 'label': 'Conventional PT', 'interventionNames': ['Other: Conventional Treatment']}], 'interventions': [{'name': 'Mobilization with Movement MWM', 'type': 'OTHER', 'description': 'Mobilization with Movement MWM of Talocrural joint in non-weight bearing position to improve Dorsiflexion Range of Motion (3 sets of 6 repetitions were applied, with a 1-minute break between sets/3 times a week) and conventional therapy which includes stretching, strengthening, balance training exercise.', 'armGroupLabels': ['Mobilization with Movement MWM of Talocrural joint + Conventional PT']}, {'name': 'Conventional Treatment', 'type': 'OTHER', 'description': '* Stretches of Hamstrings, Gastrocnemius, Soleus and hip adductors with duration of 20 sec hold/ 5 reps and Frequency: 3 times/week. Stretches will be performed passively\n* Strengthening exercises of Quadriceps and abdominal muscles three times a week.\n* Static balance exercises including single leg balance, tandem stance, weight shifting with Duration: 10 sec hold/ 5 reps Frequency: 3 times/week', 'armGroupLabels': ['Conventional PT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46600', 'city': 'Islamabad', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'KINZA ANWAR, MS-OMPT', 'role': 'CONTACT', 'email': 'kinza.anwar@riphah.edu.pk', 'phone': '+92-3239735427'}, {'name': 'MAIMOONA MUBARIK, MS-OMPT*', 'role': 'CONTACT'}, {'name': 'MAIMOONA MUBARIK, MS-OMPT*', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'PAF School for Persons With special Needs PNS, Islamabad', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}], 'centralContacts': [{'name': 'KINZA ANWAR, MS-OMPT', 'role': 'CONTACT', 'email': 'kinza.anwar@riphah.edu.pk', 'phone': '+92-3239735427'}], 'overallOfficials': [{'name': 'KINZA ANWAR, MS-OMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}