An interventional study of Powered Hip Flexion Orthosis (Hypershell X) in Multiple Sclerosis (MS) Relapsing Remitting, sponsored by University of Dayton. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Dayton · Not applicable, Interventional, and Treatment
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).
602 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 429 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →University of Dayton is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
Gait speed
Gait speed measured during a 10 meter walk
Time frame: Day 1 (immediate effect of device use)
Foot clearance
Distance that the foot clears the ground during the swing phase of gait
Time frame: Day 1 (immediate effect of device use)
Step length
Step length as measured from heel strike of the one foot to heel strike of the other foot
Time frame: Day 1 (immediate effect of device use)
Circumduction
Lateral excursion of of the foot during mid swing
Time frame: Day 1 (immediate effect of device use)
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.
Time frame: Day 1 (immediate effect of device use)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting→
University of Dayton