Multiple Sclerosis (MS) Relapsing RemittingNCT07724093
Effects of Powered Hip Flexion Device in Persons With Multiple Sclerosis
A study testing Powered Hip Flexion Orthosis (Hypershell X) in people with Multiple Sclerosis (MS) Relapsing Remitting, run by University of Dayton at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis (MS) Relapsing Remitting
- What is being tested?
- Powered Hip Flexion Orthosis (Hypershell X)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Dayton
Dayton, Ohio, 45469
Kurt Jackson, PhD, 937-229-5605, Kjackson1@udayton.edu
About this study
Official title: The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series
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?
Read the detailed description
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).
- Being tested
- Powered Hip Flexion Orthosis (Hypershell X)
- Keywords
- Multiple sclerosis, gait, exoskeleton, hip flexion orthosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Hip Flexion Orthosis (Hypershell X)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Hip flexion assist | Experimental | 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. Receives: Device: Powered Hip Flexion Orthosis (Hypershell X) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Gait speed measured during a 10 meter walk
Measured: Day 1 (immediate effect of device use)
Foot clearance
Distance that the foot clears the ground during the swing phase of gait
Measured: Day 1 (immediate effect of device use)
Secondary outcomes (3)
Step length
Step length as measured from heel strike of the one foot to heel strike of the other foot
Measured: Day 1 (immediate effect of device use)
Circumduction
Lateral excursion of of the foot during mid swing
Measured: 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.
Measured: Day 1 (immediate effect of device use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) Relapsing RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an exploratory case series
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dayton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kurt Jackson, University of Dayton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724093
- Sponsor's protocol ID
- IRB-FY2026-240
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided