Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:37 AM
Study NCT ID:
NCT07442968
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mobilization With Movement Floss Band (MWF) Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ankle application in mobilization with movement floss band and general floss band group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-21', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight bearing lunge test(WBLT)', 'timeFrame': '1 year', 'description': 'The WBLT was measured to determine the DF of the ankle on functional condition. Participants placed the foot to be measured on the measuring tape perpendicular to the wall, measured the length from the big toe to the wall on the measuring tape. Lunge posture was performed so that the knee could touch the wall within a range where the heel of the measurement foot did not float, and if successful, the big toe of the measurement foot was more 1 ㎝ away from the wall and measured until failure. The last successful point was used as a measurement.'}, {'measure': 'Range of motion(ROM)', 'timeFrame': '1 year', 'description': 'A goniometer was used to measure the manual joint motion range of the ankle, and the operating range of DF and PF was measured. The axis was measured with the lateral malleolus, the stationary arm at the fibular head, and the moving arm parallel to the fifth metatarsal bone in the neutral state of the ankle'}, {'measure': 'one leg test(OLT) - static balance ability', 'timeFrame': '1 year', 'description': 'To measure the static balance ability of the ankle, OLT was measured using a wireless APDM Movement Monitoring inertial sensor system(APDM Inc, Portland, OR, USA). OLT was performed for 30 seconds to measure the sway area, and decrease sway area mean improving static balance. Three synchronized Opal inertial sensors were equipped on both ankles and lumbar L5 via straps. The signal is sampled, automatically processed, calculated, and streamed to a laptop via the corresponding "Mobility LabTM" software package(Mobility LabTM, Arlington, VA, USA). The OLT was conducted for 30 seconds, and when the starting sound was heard, the target person was instructed to stand with one foot and balance. If the foot touched the ground 30 seconds before, it was considered a failure and carried out again.'}, {'measure': 'Y-balance test - Dynamic balance ability', 'timeFrame': '1 year', 'description': "The Y-balance test Lower Quarter(YBT-LQ; Move2Perform, Evansville, IN, USA) was used to measure the dynamic balance of the ankle. YBT-LQ consists of three pipes and one plate, and there is an indicator for measurement on each pipe. YBT-LQ has pipes in three directions from the support to the anterior(ANT), posterior lateral(PL) direction, and posterior medial(PM) direction, and the angle between the front and back pipes is 135°, and the pipe angle between the back inner and back sides is 90°. Every pipe is marked with distances in 0.5 cm. The subject's measurement foot is started in a single leg stance state by attaching the big toe to the red line of the plate. With the unsupported foot, the indicator in each direction should be reached to the tip of the toe to the maximum and returned again."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Adults']}, 'descriptionModule': {'briefSummary': 'Limited ankle mobility can affect functional movement and balance, even in healthy individuals. Floss band application is a technique in which an elastic band is wrapped around a joint during active movement to potentially improve joint mobility and functional performance. Another approach combines floss band application with mobilization with movement (MWF), which integrates joint mobilization techniques during movement.\n\nThis study examined the effects of floss band application on ankle range of motion (ROM), functional ROM, and static and dynamic balance in fifty healthy adults. Participants were randomly assigned to either a floss band group or a mobilization with movement floss band (MWF) group. Measurements were taken before and after the intervention.', 'detailedDescription': 'This study aimed to investigate the effects of floss band application on ankle joint range of motion (ROM), functional ROM, and static and dynamic balance ability in fifty healthy subjects. A pre-post experimental design was used.\n\nParticipants were randomly assigned to one of two groups: a floss band group or a mobilization with movement floss band (MWF) group. The floss band group received elastic band compression applied around the ankle joint during movement. The MWF group received floss band application combined with mobilization with movement techniques targeting the ankle joint.\n\nOutcome measures included dorsiflexion (DF), weight-bearing lunge test (WBLT) performance, and assessments of static and dynamic balance. All measurements were conducted before and immediately after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No limited ankle joint ROM\n* No pain, edema, or sprain of weight bearing joint\n* No muscle fatigue due to radical work\n* No operation of lower extremity in one year\n\nExclusion Criteria:\n\n* lower extremity orthopedic problems\n* unstable steps and balance\n* visual impairments'}, 'identificationModule': {'nctId': 'NCT07442968', 'briefTitle': 'Effects of Mobilization With Movement Floss Band (MWF) Application', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nambu University'}, 'officialTitle': 'Effects of Mobilization With Movement Floss Band (MWF) Application on Ankle Range of Motion, Weight-bearing Lunge Test, and Balance.', 'orgStudyIdInfo': {'id': 'CA17-250804-HR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mobilization with movement floss band(MWF) group', 'description': 'In this study, to apply the pressure to the ankle joint, the floss band(Sanctband COMPRE Floss, LIME GREEN; PENTEL SDN.BHD., Shah Alam, Malaysia) was applied. The thickness of the floss band is 1.1 ㎜, the width is 5 ㎝ and the length is 2 ｍ. In this study, to apply the pressure to the ankle joint, the floss band(Sanctband COMPRE Floss, LIME GREEN; PENTEL SDN.BHD., Shah Alam, Malaysia) was applied. The thickness of the floss band is 1.1 ㎜, the width is 5 ㎝ and the length is 2 ｍ.', 'interventionNames': ['Behavioral: Mobilization with movement floss band (MWF) intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Floss band group', 'description': 'Apply the floss band(Sanctband COMPRE Floss, LIME GREEN; PENTEL SDN.BHD, Shah Alam, Malaysia) with mobilization while maintaining the DF position. Using a vertically folded floss band from the heel, band passes through the medial malleous and to the lateral malleous while gliding the talus with glade 3 level.', 'interventionNames': ['Behavioral: Floss band intervention']}], 'interventions': [{'name': 'Floss band intervention', 'type': 'BEHAVIORAL', 'description': 'To apply the floss band, it starts at the dorsal of fifth metatarsal bone and wrap it horizontally twice through the metatarsal bone. After that, it comes to the medial malleolus, passes through the Achilles tendon, goes to the lateral malleolus, and then winds back to the medial malleolus by applying the figure eight knot method and winding it 3 times in total. Then, after passing the Achilles tendon from the medial malleolus, the end knot was formed by wrapping it twice with the lateral malleolus on the edge side. The floss band were wrapped so that they overlapped by 50% to the extent possible to limit blood flow. Subjects were instructed to slow down active exercise(DF and PF) at low intensity for 2 minutes after applying the floss band. After that, the floss band was removed, and in order to normalize blood flow again, they walked lightly on a flat ground for about 1 minute, and the blood flow recovered', 'armGroupLabels': ['Floss band group']}, {'name': 'Mobilization with movement floss band (MWF) intervention', 'type': 'BEHAVIORAL', 'description': 'And spread the folded area and fix the talus once again. Followed by 3 wraps completed in(to lateral malleolus, around the Achilles tendon, to medial malleolus, towards the distal head of the 5th metatarsal, around the bottom of the foot and back to the beginning)(Figure 19). Each subsequent wrap overlapped the previous by 50%, before securing the remainder of the band underneath the final wrap. Participants were instructed to perform both PF and DF to their full ROM, and completed the mobility exercises within two minutes. Floss band was then removed and the participants were instructed to stand up and walk around for two minute to allow for blood flow to return to the foot.', 'armGroupLabels': ['mobilization with movement floss band(MWF) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62271', 'city': 'Gwangju', 'state': 'Gwangsan-gu', 'country': 'South Korea', 'facility': 'Nambu University', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nambu University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Boung-hyoun Moon', 'investigatorAffiliation': 'Nambu University'}}}}