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NCT07724093

Overview

NCT ID: NCT07724093
Lead Sponsor: University of DaytonOTHER
Official Title: The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series
Brief 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. 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?
Conditions: Multiple Sclerosis (MS) Relapsing Remitting
Interventions: Powered Hip Flexion Orthosis (Hypershell X)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Jul 15, 2026Estimated
Primary Completion Date: May 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 10Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Kurt Jackson, PhDContact
Kjackson1@udayton.edu937-229-5605

Similar Studies

Participant Group/Arms

Hip flexion assistExperimental

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)