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Ankle Robot to Reduce Foot Drop in Stroke

8. mai 2020 oppdatert av: VA Office of Research and Development

Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke

Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.

The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.

This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:

  1. Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
  2. Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
  3. Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.

Studietype

Intervensjonell

Registrering (Faktiske)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke > 2 months prior in men or women
  • Residual hemiparesis of the lower extremity that includes symptoms of foot drop
  • Capable of ambulating on a treadmill with handrail support
  • Already completed all conventional physical therapy
  • Adequate language and cognitive function to provide informed consent and participate in testing and training

Exclusion Criteria:

  • Cardiac history of:

    • Unstable angina
    • Recent (< 3 months) myocardial infarction
    • Congestive heart failure (NYHA category II or higher)
    • Hemodynamic valvular dysfunction
    • Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)

  • Medical history of:

    • Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
    • Symptomatic peripheral arterial occlusive disease
    • Orthopedic or chronic pain conditions restricting exercise
    • Pulmonary failure requiring oxygen
    • Uncompensated renal failure
    • Active cancer

  • Neurological history and exam consistent with:

    • Dementia
    • Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
    • Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
    • Untreated major depression

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treadmill+anklebot
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
Enhet: Treadmill plus anklebot
This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Andre navn:
  • Tmr
Aktiv komparator: Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
Atferdsmessig: Treadmill only
This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Andre navn:
  • TM

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gait Velocity During Self-selected Overground Walking
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Gait velocity during self-selected overground walking measured in cm/sec
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Tidsramme: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Peak Dorsiflexion Angle During Swing Phase of Gait
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Degrees; extent of ankle dorsiflexion to enable foot clearance
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Postural Sway Areas During Quiet Standing
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
cm^2; extent of postural deviations to assess static postural control
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Ratio of Asymmetric Loading in Quiet Standing
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Peak Paretic Push Off Forces During Gait Initiation
Tidsramme: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Newtons; magnitude of forward ground reaction forces
Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VA Office of Research and Development

Etterforskere

  • Hovedetterforsker: Steven J Kittner, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2015

Primær fullføring (Faktiske)

1. april 2019

Studiet fullført (Faktiske)

30. juni 2019

Datoer for studieregistrering

Først innsendt

19. juni 2015

Først innsendt som oppfylte QC-kriteriene

24. juni 2015

Først lagt ut (Anslag)

29. juni 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • N1699-R

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Ja

produkt produsert i og eksportert fra USA

Nei

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