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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis (MS) Relapsing Remitting
• Intervention / Treatment: Device: Powered Hip Flexion Orthosis (Hypershell X)

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kurt Jackson, PhD; Phone Number: 937-229-5605; Email: Kjackson1@udayton.edu

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45469
      • University of Dayton
      • Contact: Kurt Jackson, PhD; Phone Number: 937-229-5605; Email: Kjackson1@udayton.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hip flexion assist; Participants will perform a series of 10 meters walks while wearing the hip flexion assist device under the following conditions.; No assistance (passive mode); 25% power assistance; 50% power assistance; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	Gait speed measured during a 10 meter walk	Day 1 (immediate effect of device use)
Foot clearance	Distance that the foot clears the ground during the swing phase of gait	Day 1 (immediate effect of device use)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length	Step length as measured from heel strike of the one foot to heel strike of the other foot	Day 1 (immediate effect of device use)
Circumduction	Lateral excursion of of the foot during mid swing	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.	Day 1 (immediate effect of device use)

Collaborators and Investigators

• Sponsor: University of Dayton

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: gait; Multiple sclerosis; exoskeleton; hip flexion orthosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: IRB-FY2026-240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No