Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 7:17 AM
Study NCT ID:
NCT06009692
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric visual analogue scale (VAS)', 'timeFrame': '2 weeks', 'description': 'Numeric visual analogue scale (VAS) is a self-reported assessment that consists of a line with severe anchors ranging from "no pain" to "intense pain", which can be vertical or horizontal. Most frequently 10 cm long, this line serves as a continuum of pain severity. High test-retest reliability for the VAS has been recorded (ICC = 0.71-0.99). VAS is regarded as a powerful, therapeutically practical, accurate, and true measure of pain severity.'}, {'measure': 'Upper Extremity Functional Scale (UEFS)', 'timeFrame': '2 weeks', 'description': 'Upper Extremity Functional Scale (UEFS) is an 8-item, region-specific questionnaire designed to evaluate diseases of the upper extremities caused by work. The UEFS is a valid, reliable, and responsive tool created to assess how patients with a range of diseases are affected by upper extremity disorders in terms of function. UEFS demonstrate good internal consistency (Cronbach alpha \\> 0.83).'}, {'measure': 'Jamar hand held dynamometer', 'timeFrame': '2 weeks', 'description': 'Jamar hand held dynamometer is widely used in clinical practice and research as a result of the American Society of Hand Therapists (ASHT) recommendation of it as the gold standard. The ICC for the Jamar dynamometer ranged from .996 to .998 (p\\< 0.05).'}, {'measure': 'Range of Motion', 'timeFrame': '2 weeks', 'description': 'Goniometer is a method for measuring joint range of motion (ROM) that is widely accepted. It uses accurate and reliable measurement tools, especially the universal goniometer. For goniometry, Intraclass Correlation Coefficients (ICC- 3, k) of 0.94 showed excellent intra-ratter reliability.'}, {'measure': 'Nottingham sensory assessment Scale', 'timeFrame': '2 weeks', 'description': "The Nottingham sensory assessment is a standardized scale for assessing sensory assessment in stroke patients. The NSA consists of 20 items and four subscales. The subscales included proprioception, stereognosis, two-point discrimination and tactile feeling. Each subscales item on tactile location on both sides of the body and bilateral simultaneous contact can be graded on the scale of 0-2. The Cronbach's alpha was used to evaluate internal consistency, values over 0.70 indicate Strong internal consistency."}, {'measure': 'Wolf Motor Function Test', 'timeFrame': '2 weeks', 'description': 'Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time, Functional ability \\&Strength. It Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high inter rater reliability, internal consistency, test-retest reliability, and adequate stability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper limb functions', 'Neurodynamics', 'Pronator Teres Syndrome', 'Task Oriented training'], 'conditions': ['Pronator Teres Syndrome']}, 'descriptionModule': {'briefSummary': 'The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and sensory functions and to compare the effects of slider versus tensioner neuro-dynamic techniques on upper limb motor and sensory functions in pronator teres syndrome.', 'detailedDescription': 'The study aimed to determine the effects of neuro-dynamic techniques on upper limb motor and sensory functions and to compare the effects of slider versus tensioner neuro-dynamic techniques on upper limb motor and sensory functions in pronator teres syndrome.\n\nPronator teres syndrome is a rare condition and easily overlooked and mistaken for the more prevalent carpal tunnel syndrome. The median nerve may also be squeezed between the heads of the pronator teres muscle in addition to the carpal tunnel. Patients report pain, numbness, or paresthesia over the lateral 3.5-digit area and anterior forearm, which worsens with forced pronation. This condition is most common in the dominant hand or sometimes can be associated with advanced forearm muscle.in our routine clinical practice, The neuro-dynamic techniques is not that common in neurological physical therapy practice so the effects of neuro -dynamics with conventional therapy needs to be evaluated for better outcomes in upper limb functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with pronator teres syndrome\n* At least 6 working hours/ day\n* Positive Tinel's sign at pronator area (Hoffman's sign)\n* Positive Pronator teres syndrome test\n\nExclusion Criteria:\n\n* Any previous history of metabolic disease, liver disease/ diabetes\n* History of previous injuries to the cervical spine including radiculopathies and myelopathies as well as spinal stenosis and/or spinal disc herniation"}, 'identificationModule': {'nctId': 'NCT06009692', 'briefTitle': 'Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Neuro-dynamic Mobilization Techniques on Upper Limb Functions in Pronator Teres Syndrome', 'orgStudyIdInfo': {'id': 'Umaira Sattar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upper Limb Neurodynamics Group', 'description': 'Upper limb Neuro-dynamics (Slider/Tensioner Technique) along with Task Oriented Training', 'interventionNames': ['Other: Upper limb Neuro-dynamics (Slider/ Tensioner Technique)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Upper Limb Conventional Therapy', 'description': 'Stretching, Strengthening exercises along with Task Oriented Training', 'interventionNames': ['Other: Conventional Therapy for Upper limb']}], 'interventions': [{'name': 'Upper limb Neuro-dynamics (Slider/ Tensioner Technique)', 'type': 'OTHER', 'description': "The experimental group will receive neuro-dynamic mobilization techniques along with task oriented training. Slider versus tensioner technique will be applied according to each patient's need. Session time will be 25-30 minutes. Four series of 10 tensioning movements at a rhythm of ∼6s per cycle and 1 min rest between each series will be performed. After each cycle of 10 repetitions, the position will hold for 10s.", 'armGroupLabels': ['Upper Limb Neurodynamics Group']}, {'name': 'Conventional Therapy for Upper limb', 'type': 'OTHER', 'description': "Conventional treatment will include therapeutic ultrasound for 4 min, TENS for 10 min. Task oriented training will be designed according to patient's functional outcomes. Sessions will be given for 6 days a week, 25-30 minutes per day.", 'armGroupLabels': ['Upper Limb Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46060', 'city': 'Islamabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Al-Nafees hospital', 'geoPoint': {'lat': 29.7426, 'lon': 73.14353}}], 'overallOfficials': [{'name': 'Abrish Habib Abbasi, MS-NMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}