Nctid:
NCT06612983
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"OTHER", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"All participants will experience the IASTM treatment first and the first session and the walking - sham treatment at the second session."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>70}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-01-09", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2023-02-28", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-02-28", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Range of Motion", "timeFrame"=>"From baseline to end of session at one hour", "description"=>"Bilateral knee flexion and extension as well as ankle plantarflexion, dorsiflexion, inversion and eversion range of motion measurements were taken in supine using a goniometer."}, {"measure"=>"Gait", "timeFrame"=>"From baseline to end of session at one hour", "description"=>"Gait analysis was conducted using Noraxon MyoMuscle System with Ultium insoles placed in the participants shoes. The software collected data on center of gravity, center of pressure, step length, stride length, and stride frequency."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Instrument assisted soft tissue mobilization", "Range of Motion", "Gait"], "conditions"=>["Healthy"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy tissue of adult volunteers. The main questions it aims to answer are:\n\n* Does IASTM treatment have an effect on range of motion (ROM) as measured in the ankle and knee?\n* Does IASTM treatment have an effect on movement patterns including gait - how a person walks? Researchers will compare pre-test and post-test data from the same individual on their day with treatment to the pre-test and post-test data from the same individual on their day without treatment to see if ROM or gait are effected by use of IASTM.\n\nParticipants will:\n\n* Complete a past medical and injury history questionnaire\n* Have ankle and knee range of motion (ROM) measurements taken on both lower extremities using a goniometer\n* Undergo a gait analysis to determine center of gravity, center of pressure, step length, stride length, and stride frequency using Noraxon MyoMuscle Ultium Insoles\n* Undergo IASTM treatment techniques using the HawkGrips tools including applying emollient to the skin to reduce friction on the surface followed by scanning the gastroc/soleus complexes and Achilles tendons using the HG8-Scanner tool for 15 strokes in each direction to identify areas of concern, then the concave tool corresponding to the size of the structure being treated will be used (HG6-Large Multi-Curve, HG5-Medium Multi-Curve, HG4-Small Multi-Curve) for 15 strokes in each direction. Treatment techniques should last for 10 minutes in total on each side.\n* Complete the ankle and knee ROM measurements as well as gait analysis again to document progress at the end of the first session.\n* Return three to seven days after the first session in which the subject will have the walking treatment.\n* Undergo the same baseline pre-test measurements for range of motion and gait analysis as the first session\n* Experience the walking treatment by walking for the same time period that the IASTM treatment took at the first session\n* Undergo the post-test range of motion and gait analysis for data comparison.", "detailedDescription"=>"No further information to note than what is described in the summary or elsewhere"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Individuals from a small regional university student body, faculty and staff may choose to volunteer to participate in this study.\n\nExclusion Criteria:\n\n* Acute spinal cord injury with neurological deficits\n* Neurological disorders\n* Acute lower extremity injury such as sprain or strain\n* Acute lower extremity pain causing gait deviation\n* Any type of lower extremity fracture within the past 12 months\n* Lumbar disc pathology with radicular symptoms\n* Use of blood thinning or clotting medications\n* Known connective tissue disorder"}, "identificationModule"=>{"nctId"=>"NCT06612983", "acronym"=>"(IASTM)", "briefTitle"=>"Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Gait", "organization"=>{"class"=>"OTHER", "fullName"=>"Minot State University"}, "officialTitle"=>"Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Gait", "orgStudyIdInfo"=>{"id"=>"2242"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"IASTM", "description"=>"This arm of the study received treatment on day one and walking treatment on day two.", "interventionNames"=>["Other: Instrument Assisted Soft Tissue Mobilization", "Other: Walking Treatment"]}], "interventions"=>[{"name"=>"Instrument Assisted Soft Tissue Mobilization", "type"=>"OTHER", "otherNames"=>["HawkGrips"], "description"=>"Instrument assisted soft tissue mobilization is a technique that is applied using specially designed tools/instruments to provide a mobilizing effect to soft tissues including the skin, fascia, muscles, and tendons by its various direct compressive stroke techniques on the gastroc/soleus complexes and Achilles tendons in the first session.", "armGroupLabels"=>["IASTM"]}, {"name"=>"Walking Treatment", "type"=>"OTHER", "description"=>"Movement itself should promote mobility so walking steadily for the same period of time as the IASTM had taken to complete is the sham treatment in second session.", "armGroupLabels"=>["IASTM"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"58707", "city"=>"Minot", "state"=>"North Dakota", "country"=>"United States", "facility"=>"Minot State University", "geoPoint"=>{"lat"=>48.23251, "lon"=>-101.29627}}], "overallOfficials"=>[{"name"=>"Beth Marschner, DPT", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Minot State University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"The individual participant data is not the main focus of this study. The overall findings of the study with the larger number of participants to look at the trend is what will be shared (presented or published). The IRB proposal for this study included confidentiality of each individual participant as that will be maintained, but the global findings are what will be shared after data analysis for comparison."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Beth Marschner", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Minot State University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor", "investigatorFullName"=>"Beth Marschner", "investigatorAffiliation"=>"Minot State University"}}}}
