Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:09 AM
Study NCT ID:
NCT07491432
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lower Extremity Neural Mobilization on Gait Biomechanics and Spinal Alignment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessments were performed by a physiotherapist who was blinded to group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study used a parallel-group randomized design. Participants were randomly assigned to either the neural slider group or the neural tensioner group using a sealed-envelope method. Each participant received a single session of the allocated neural mobilization technique. Outcome assessments were performed before and immediately after the intervention. The two groups were compared in terms of acute changes in gait parameters and spinal alignment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Speed', 'timeFrame': 'baseline and 5 minutes after the intervention', 'description': 'Gait speed expressed in meters per second (m/s), calculated as total walking distance divided by time during a 1-minute walk on a straight, level surface. Measurements were obtained using the OneStep smartphone application, with the smartphone securely attached to the lateral aspect of the thigh to capture inertial motion data. Speed was derived from step detection and stride timing algorithms. The outcome represents the change from pre- to post-intervention.'}, {'measure': 'Gait Cadence', 'timeFrame': 'baseline and 5 minutes after the interventio', 'description': 'Cadence expressed in steps per minute (steps/min), calculated as the total number of detected steps divided by walking time. Step events were identified through thigh-mounted inertial sensor data captured by the OneStep application during a 1-minute walking trial. The outcome represents the change from pre- to post-intervention.'}, {'measure': 'Step Length', 'timeFrame': 'baseline and 5 minutes after the intervention', 'description': 'Step length expressed in centimeters (cm), defined as the linear distance between the initial contact of one foot and the subsequent initial contact of the contralateral foot. Step length was estimated using validated gait algorithms based on stride time and thigh kinematics recorded by the OneStep application. The outcome represents the change from baseline to post-intervention.'}, {'measure': 'Stride Length', 'timeFrame': 'baseline and 5 minute after interventions.', 'description': 'Stride length expressed in centimeters (cm), defined as the linear distance between two successive initial contacts of the same foot. Stride length was derived from inertial sensor data captured from the thigh during standardized walking. The outcome represents the change between pre- and post-intervention.'}, {'measure': 'Step Length Asymmetry', 'timeFrame': 'baseline and 5 minute later interventions', 'description': 'ep length asymmetry expressed as a percentage (%), calculated as the normalized difference between right and left step lengths during walking. Values were automatically derived from spatiotemporal gait data recorded by the thigh-mounted smartphone. The outcome represents the change from pre- to post-intervention.'}, {'measure': 'Step Width', 'timeFrame': 'baseline and 5 minutes later interventions', 'description': 'step width expressed in centimeters (cm), defined as the mediolateral distance between the center points of the heels during consecutive foot contacts. This parameter was estimated using validated spatial gait algorithms within the OneStep application. The outcome represents the change from baseline to post-intervention.'}, {'measure': 'Single Support Time', 'timeFrame': 'baseline and 5 minutes after interventions', 'description': 'Right single support time expressed as a percentage of the gait cycle (%), defined as the duration during which only the investigated limb is in contact with the ground. Gait cycle phases were automatically detected using thigh-based inertial motion data. The outcome represents the change from pre- to post-intervention.'}, {'measure': 'Double Support Time', 'timeFrame': 'baseline and 5 minutes after interventions', 'description': 'Double support time expressed as a percentage of the gait cycle (%), defined as the duration during which both feet are simultaneously in contact with the ground. This parameter was calculated using gait phase detection algorithms from inertial sensor data recorded during walking. The outcome represents the change between pre- and post-intervention assessments.'}], 'secondaryOutcomes': [{'measure': 'Pelvic Inclination Angle', 'timeFrame': 'baseline and 5 minutes after interventions', 'description': 'Pelvic inclination angle expressed in degrees (°), measured in standing position using a bubble inclinometer placed between the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS). The angle represents the sagittal plane tilt of the pelvis. The outcome represents the change from pre- to post-intervention.'}, {'measure': 'Cervical Lordosis Angle', 'timeFrame': 'baseline and 5 minutes later interventions', 'description': 'Cervical lordosis angle expressed in degrees (°), measured in neutral standing posture using a bubble inclinometer positioned between the spinous processes of C1 and C7. The angle represents sagittal curvature of the cervical spine. The outcome represents the change from baseline to post-intervention.'}, {'measure': 'Thoracic Kyphosis Angle', 'timeFrame': 'baseline and 5 minutes after interventions', 'description': 'Thoracic kyphosis angle expressed in degrees (°), measured using a bubble inclinometer placed between T1 and T12 spinous processes in standing posture. The outcome represents the change between pre- and post-intervention measurements.'}, {'measure': 'Lumbar Lordosis Angle', 'timeFrame': 'baseline and 5 minutes after interventions', 'description': 'Lumbar lordosis angle expressed in degrees (°), measured using a bubble inclinometer placed between L1 and L5 spinous processes in standing posture. The outcome represents the change from pre- to post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gait Biomechanics', 'Neural Mobility', 'Postural Alignment']}, 'descriptionModule': {'briefSummary': 'This randomized controlled single-blinded trial aimed to compare the immediate effects of lower extremity neural slider and neural tensioner exercises on gait parameters and spinal alignment in sedentary young adults. Sixty healthy sedentary individuals aged 18-30 years were randomly assigned to receive either a neural slider or neural tensioner intervention. Spatiotemporal gait parameters were assessed using a validated smartphone-based gait analysis application, and spinal alignment angles were measured with a bubble inclinometer before and immediately after a single exercise session. The primary outcome was the acute change in gait-related parameters, and secondary outcomes included changes in spinal alignment and pelvic inclination angles.', 'detailedDescription': 'This randomized controlled, single-blinded experimental study was conducted between February and April 2024 to investigate the acute effects of lower extremity neural mobilization techniques on gait biomechanics and spinal alignment in sedentary individuals.\n\nSixty healthy sedentary participants (30 females, 30 males) aged 18-30 years were enrolled. Participants were randomly allocated to either a neural slider group or a neural tensioner group using a sealed-envelope randomization method. Allocation concealment was ensured by an independent researcher, and all outcome assessments were performed by a blinded physiotherapist.\n\nEach participant underwent baseline (pre-test) assessments followed by a single session of neural mobilization exercise (3 minutes total, 3 sets of 30 repetitions). Post-intervention measurements were performed five minutes after completion of the exercise.\n\nThe primary outcome was the immediate change in spatiotemporal gait parameters, including gait speed, cadence, step length, step length asymmetry, base of support, single and double support times, and gait score. Gait was assessed using the OneStep smartphone application, which has demonstrated high validity compared to laboratory-based gait analysis systems.\n\nSecondary outcomes included changes in spinal alignment and pelvic inclination angles, measured using a bubble inclinometer. Cervical lordosis, thoracic kyphosis, lumbar lordosis, total spinal mobility, and pelvic tilt angles were evaluated in neutral standing position.\n\nNo adverse events were reported during or after the interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 30 years\n* Sedentary lifestyle (no regular structured exercise within the past 6 months)\n* No history of lower extremity or spinal surgery\n* No diagnosed neurological disorder\n* No diagnosed musculoskeletal disorder\n* No current lower extremity pain or functional limitation\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* History of hamstring injury\n* Current low back, hip, or knee pain\n* Known peripheral nerve injury or neurological condition\n* Any condition limiting safe participation in neural mobilization exercises\n* Inability to complete the intervention protocol\n* Withdrawal from the study before post-intervention assessment'}, 'identificationModule': {'nctId': 'NCT07491432', 'briefTitle': 'Effects of Lower Extremity Neural Mobilization on Gait Biomechanics and Spinal Alignment', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Democracy University'}, 'officialTitle': 'Acute Effects of Lower Extremity Neural Mobilization on Gait Biomechanics and Spinal Alignment: A Comparison of Neural Slider and Neural Tensioner Techniques', 'orgStudyIdInfo': {'id': 'neuralmobilization'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neural Slider Group', 'description': 'Lower Extremity Neural Slider Exercise', 'interventionNames': ['Other: Lower Extremity Neural Slider Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Neural Tensioner Group', 'description': 'Lower Extremity Neural Tensioner Exercise', 'interventionNames': ['Other: Lower Extremity Neural Tensioner Exercise']}], 'interventions': [{'name': 'Lower Extremity Neural Slider Exercise', 'type': 'OTHER', 'description': 'A lower extremity neural slider technique applied in supine position. The movement sequence involved alternating cervical extension with simultaneous knee extension and ankle dorsiflexion, followed by cervical flexion combined with knee flexion and ankle plantarflexion. The intervention was performed for a total of 3 minutes, consisting of 3 sets of 30 repetitions (90 repetitions total). Each repetition included a 1-second hold at end range. The technique was administered by a physiotherapist under standardized conditions.', 'armGroupLabels': ['Neural Slider Group']}, {'name': 'Lower Extremity Neural Tensioner Exercise', 'type': 'OTHER', 'description': 'A lower extremity neural tensioner technique applied in supine position. The movement sequence involved simultaneous cervical flexion with knee extension and ankle dorsiflexion to increase neural tension, followed by return to neutral position with cervical extension and knee flexion. The intervention lasted 3 minutes and consisted of 3 sets of 30 repetitions (90 repetitions total), with a 1-second hold at end range. The technique was administered by a physiotherapist under standardized conditions.', 'armGroupLabels': ['Neural Tensioner Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35290', 'city': 'Izmir', 'state': 'Konak', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Democracy University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Democracy University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Ezgi Ünüvar Yüksel', 'investigatorAffiliation': 'Izmir Democracy University'}}}}