Not yet recruitingNot a drug-phase studyRelapsing and progressiveNCT07724093

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Powered Hip Flexion Orthosis (Hypershell X)

What it measured

Main measures

  • Gait speed

    Day 1 (immediate effect of device use)

    Walking and mobility
  • Foot clearance

    Day 1 (immediate effect of device use)

    Walking and mobilityHow the body handles the medicine

Other measures (3)

  • Step length

    Day 1 (immediate effect of device use)

  • Circumduction

    Day 1 (immediate effect of device use)

  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

    Day 1 (immediate effect of device use)

    Quality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 to 80

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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?

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History

    1. Started

      Jul 2026

    2. Main results due

      May 2027

    3. Finished

      May 2028

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