Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT06343506
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2024-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ankle Dorsiflexion Changes With Assisted Stretching Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle Range of Motion', 'timeFrame': 'Following 3 Weeks of Device Use', 'description': 'Range of motion during passive and active movement.'}], 'secondaryOutcomes': [{'measure': 'Ankle Strength', 'timeFrame': 'Following 3 Weeks of Device Use', 'description': 'Strength in dorsiflexion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Physical Therapy Modality']}, 'descriptionModule': {'briefSummary': "Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of limited ankle range of dorsiflexion by physical therapist\n\nExclusion Criteria:\n\n* Inability to perform testing activities as described in the consent form by self-report\n* Inability to perform daily stretching with the device by self-report'}, 'identificationModule': {'nctId': 'NCT06343506', 'briefTitle': 'Ankle Dorsiflexion Changes With Assisted Stretching Device', 'organization': {'class': 'OTHER', 'fullName': 'Montana State University'}, 'officialTitle': 'Ankle Dorsiflexion Changes With Assisted Stretching Device', 'orgStudyIdInfo': {'id': '2023-929-EXPEDITED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Affected Individuals', 'interventionNames': ['Device: Grassroots Ankle Flex']}], 'interventions': [{'name': 'Grassroots Ankle Flex', 'type': 'DEVICE', 'description': "This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The Ankle Flex device is used to stretch patients into a dorsiflexion position by securing the foot to the base of the device and the shin to the leg strap attached to the pulley system. The patients can then pull the handle of the pulley system, giving them the mechanical advantage to gently mobilize their ankle into dorsiflexion with their foot firmly secured to the base of the device. This can allow for a deeper and more controlled stretch than previous stretching methods done during at home care.", 'armGroupLabels': ['Affected Individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59717', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Neuromuscular Biomechanics Laboratory', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}], 'overallOfficials': [{'name': 'Corey Pew, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montana State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montana State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Corey Alexander Pew', 'investigatorAffiliation': 'Montana State University'}}}}