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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series
- ClinicalTrials.gov ID
- NCT07724093
- Acronym / sponsor ID
- IRB-FY2026-240
- Keywords
- Multiple sclerosis, gait, exoskeleton, hip flexion orthosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of DaytonUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an exploratory case series
| Arm | Type | Receives |
|---|---|---|
| Hip flexion assist | Experimental | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Hip flexion assist |
Primary outcome
Gait speed
Time frame: Day 1 (immediate effect of device use)
Gait speed measured during a 10 meter walk
Foot clearance
Time frame: Day 1 (immediate effect of device use)
Distance that the foot clears the ground during the swing phase of gait
3 secondary outcomes
Step length
Time frame: Day 1 (immediate effect of device use)
Circumduction
Time frame: Day 1 (immediate effect of device use)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Time frame: Day 1 (immediate effect of device use)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kurt Jackson, PhD (937-229-5605, Kjackson1@udayton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Day 1 (immediate effect of device use)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.