[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07724093":3,"trial-entities:NCT07724093":97,"trial-summary:NCT07724093":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":47,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":74,"locations":77,"central_contacts":92,"overall_officials":94,"references":95,"see_also_links":96},"NCT07724093","IRB-FY2026-240","Effects of Powered Hip Flexion Device in Persons With Multiple Sclerosis","The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series","NOT_YET_RECRUITING","2028-05-01","2026-07","2026-07-23","2026-07-15","University of Dayton","OTHER",false,"The purpose of this study is to assess the immediate effects of a commercially available non-FDA regulated powered hip flexion assist device (Hypershell X, Shenzhen, China) on walking ability in persons with MS. The main question it aims to answer is: Does a powered hip flexion device provide immediate improvements in walking ability over short distances for people with MS?","Individuals with multiple sclerosis (MS) frequently experience problems with walking that may include difficulty with advancing the leg during the swing phase of gait which can lead to a loss of independence and a higher risk of falls. To improve walking ability in this population, devices such as ankle-foot orthoses (AFO) and functional electrical stimulation (FES) are commonly used. However, recent advances in technology and robotics have led to the development of affordable and commercially available battery powered exoskeletons marketed towards improving activities such as hiking, running and cycling. There is emerging but limited evidence that hip flexion-assisting devices can modify kinematics and muscle activity during gait in people with MS, with several small-scale studies showing tolerability and shifts toward more normal hip motion during walking. However, there are no studies on the use of new commercially available powered hip flexion assist devices. Therefore, the purpose of this case series is to assess the immediate effects on walking ability of a commercially available, non-FDA regulated, powered hip flexion assist device (Hypershell X, Shenzhen, China).",[19],"Multiple Sclerosis (MS) Relapsing Remitting",[21,22,23,24],"Multiple sclerosis","gait","exoskeleton","hip flexion orthosis","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},10,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Powered Hip Flexion Orthosis (Hypershell X)","Participants will perform a series of 10 meters walks while wearing the hip flexion assist device under the following conditions. 1) No assistance (passive mode) 2) 25% power assistance 3) 50% power assistance 4) 75% power assistance During the trial subjects will wear motion sensors that provide the following gait parameters: speed, step and stride length, foot clearance, foot angle at heel strike, circumduction, single and double support time.",[38],"Hip flexion assist",[40,44],{"measure":41,"description":42,"timeFrame":43},"Gait speed","Gait speed measured during a 10 meter walk","Day 1 (immediate effect of device use)",{"measure":45,"description":46,"timeFrame":43},"Foot clearance","Distance that the foot clears the ground during the swing phase of gait",[48,51,54],{"measure":49,"description":50,"timeFrame":43},"Step length","Step length as measured from heel strike of the one foot to heel strike of the other foot",{"measure":52,"description":53,"timeFrame":43},"Circumduction","Lateral excursion of of the foot during mid swing",{"measure":55,"description":56,"timeFrame":43},"Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)","The purpose of the QUEST 2.0© questionnaire is to evaluate satisfaction with assistive device use. The questionnaire consists of 12 satisfaction items. Participants will rate their satisfaction with the Hypershell device using a scale of 1 to 5.","ALL","18 Years","80 Years",{"inclusion":61,"exclusion":67,"raw_text":73},[62,63,64,65,66],"Age 18-80","Diagnosis of relapsing remitting, primary progressive or secondary progressive MS","Unilateral or bilateral hip flexion weakness (Manual muscle testing score of 3 or less)","Ability to walk at least 30 meters without requiring rest and without physical support or assistance from another person.","Waist circumference 26-48\", Height 5 '- 6'2\", Weight 100-230lbs",[68,69,70,71,72],"Prior regular use of a hip flexion orthosis within the past 6 months.","Cognitive or communication deficits that would limit ability to participate safely.","Significant pain or deformity of the lower extremities that could impact walking ability.","Severe spasticity (Modified Ashworth Score of 3 or 4) of the hips or lower extremities that could impact walking ability.","Any other neurological conditions that may affect gait.","Inclusion Criteria:\n\n* Age 18-80\n* Diagnosis of relapsing remitting, primary progressive or secondary progressive MS\n* Unilateral or bilateral hip flexion weakness (Manual muscle testing score of 3 or less)\n* Ability to walk at least 30 meters without requiring rest and without physical support or assistance from another person.\n* Waist circumference 26-48\", Height 5 '- 6'2\", Weight 100-230lbs\n\nExclusion Criteria:\n\n* Prior regular use of a hip flexion orthosis within the past 6 months.\n* Cognitive or communication deficits that would limit ability to participate safely.\n* Significant pain or deformity of the lower extremities that could impact walking ability.\n* Severe spasticity (Modified Ashworth Score of 3 or 4) of the hips or lower extremities that could impact walking ability.\n* Any other neurological conditions that may affect gait.",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Dayton","Ohio","45469","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Kurt Jackson, PhD","CONTACT","937-229-5605","Kjackson1@udayton.edu",{"lat":90,"lon":91},39.75895,-84.19161,[93],{"name":85,"role":86,"phone":87,"email":88},[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Multiple Sclerosis",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This interventional study plans to enroll 10 participants. It will test the immediate effects of a powered hip flexion device at different assistance levels.","completed","Study of a Powered Hip Flexion Device for Multiple Sclerosis","This study is looking at how a powered hip flexion device, the Hypershell X, immediately affects walking ability in people with Multiple Sclerosis (MS). Researchers want to see if using this device can improve how you walk over short distances. You might be able to join if you are 18-80 years old, have relapsing-remitting, primary progressive, or secondary progressive MS, and have weakness in your hip muscles. You also need to be able to walk at least 30 meters without help. The study will measure improvements in your walking speed and how high you lift your foot (foot clearance) while using the device at different power levels. The study plans to enroll 10 participants, but its current status is unclear.","The primary endpoints, gait speed and foot clearance, are measured on Day 1, indicating immediate effects of device use.",120,"Participants will perform a series of 10-meter walks while wearing the Hypershell X device under various power settings. Motion sensors will be worn during these walks.","Not stated in the trial record.",[],"v2"]