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Effects of Powered Hip Flexion Device in Persons With Multiple Sclerosis

20. juli 2026 opdateret af: Kurt Jackson, University of Dayton

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?

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Hip flexion assist

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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gait speed
Tidsramme: Day 1 (immediate effect of device use)
Gait speed measured during a 10 meter walk
Day 1 (immediate effect of device use)
Foot clearance
Tidsramme: Day 1 (immediate effect of device use)
Distance that the foot clears the ground during the swing phase of gait
Day 1 (immediate effect of device use)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Step length
Tidsramme: Day 1 (immediate effect of device use)
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
Tidsramme: Day 1 (immediate effect of device use)
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)
Tidsramme: Day 1 (immediate effect of device use)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Dayton

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-FY2026-240

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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