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Gait Stability After Stroke (AdaptGait)

Influence of Added Tasks and Different Environmental Conditions on Gait Stability After Stroke

The study will investigate gait stability in individuals post-stroke compared with age- and sex-matched healthy adults. Participants will undergo laboratory-based walking assessments under different environmental conditions, including level walking, uphill and downhill walking, and unexpected slip perturbations, with and without added cognitive, postural, and load-carrying tasks. The primary outcome measures will be the Margin of Stability (MOS), step width, and step width variability.

Studieoversikt

Detaljert beskrivelse

: The study will recruit 20-30 adults post-stroke and an equal number of healthy controls. Participants post-stroke will be recruited after discharge from their regular rehabilitation. Participants will complete a single assessment session involving walking on a instrumented dual-belt treadmill mounted on a Stewart platform while secured with a safety harness. Walking conditions will include level, inclined, declined, and slip-perturbed walking, as well as walking combined with serial subtraction, head turning, or backpack carrying. Three-dimensional motion capture, force measurements, and surface electromyography will be used to quantify gait biomechanics and neuromuscular responses. The effects of environmental conditions and added tasks on gait stability, balance control, and fall risk will be compared between groups to identify biomechanical and neuromuscular markers associated with increased fall susceptibility after stroke.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

      • Ljubljana, Slovenia, 1000
        • University Rehabilitation Institute, Republic of Slovenia

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 til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria - stroke group:

  • Discharge from regular rehabilitation
  • First unilateral ischemic or hemorrhagic stroke affecting one of the cerebral hemispheres
  • More than 3 months post-stroke
  • Mini-Mental State Examination score ≥24 or cognitive ability to participate in the study
  • Ability to walk independently in the community without a walking aid
  • Moderate to mild balance impairment (Mini-BESTest score 16-25)
  • Sufficient cognitive and physical ability to participate
  • Ability to walk on a treadmill in intervals for up to 30 altogether

Inclusion Criteria - healthy control group:

  • Age- and sex-matched to participants with stroke
  • Mini-BESTest score ≥ 16
  • Sufficient cognitive and physical ability to participate
  • Ability to walk on a treadmill in intervals for up to 30 altogether

Exclusion Criteria (both groups):

  • Musculoskeletal impairments affecting gait or balance
  • Severe cardiovascular disease or heart failure (NYHA Class III-IV)
  • Other neurological disorders

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Post-stroke patients

Adults with unilateral stroke (>3 months post-stroke) will undergo assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying).

Level treadmill walking

Uphill treadmill walking

Downhill treadmill walking

Slip-perturbed treadmill walking

Added task: serial subtraction

Added task: head turning

Added task: backpack carrying

Aktiv komparator: Control group: healthy control participants

Age- and sex-matched healthy adults will undergo the same assessment protocol as the post-stroke patients, i.e., assessment of gait stability and balance responses during treadmill walking under different environmental conditions (level, uphill, downhill, and slip-perturbed walking) and added tasks (serial subtraction, head turning, and backpack carrying).

Level treadmill walking

Uphill treadmill walking

Downhill treadmill walking

Slip-perturbed treadmill walking

Added task: serial subtraction

Added task: head turning

Added task: backpack carrying

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Margin of Stability (MOS)
Tidsramme: During the intervention (periprocedurally)

Margin of stability in the anteroposterior and mediolateral directions calculated from kinematic and kinetic gait data during walking under different environmental conditions and added tasks, expressed in cm (more is better)

During the intervention (periprocedurally)
Step Width
Tidsramme: During the intervention (periprocedurally)

Mean step width measured during walking under different environmental conditions and added tasks, expressed in cm (less is better)

During the intervention (periprocedurally)
Step Width Variability
Tidsramme: During the intervention (periprocedurally)

Variability of step width calculated across consecutive gait cycles during walking under different environmental conditions and added tasks, , expressed as coeffcient of variation (less is better)

During the intervention (periprocedurally)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Spatiotemporal Gait Parameter 1: Cadence
Tidsramme: During the intervention (periprocedurally)

Gait cadence (in steps/min; less is better) measured using the instrumented treadmill

During the intervention (periprocedurally)
Spatiotemporal Gait Parameter 2: Step Length
Tidsramme: During the intervention (periprocedurally)

Gait step length (in cm, more is better) measured using the instrumented treadmill

During the intervention (periprocedurally)
Spatiotemporal Gait Parameter 3: Stance Time
Tidsramme: During the intervention (periprocedurally)

Gait stance time (in s, less is better) measured using the instrumented treadmill

During the intervention (periprocedurally)
Spatiotemporal Gait Parameter 4: Swing Time
Tidsramme: During the intervention (periprocedurally)

Gait swing time (in cm, more is better) measured using the instrumented treadmill

During the intervention (periprocedurally)
Kinetic Variable 1: Ground Reaction Force
Tidsramme: During the intervention (periprocedurally)

Ground reaction force in antero-posterior direction (in N; less is better) measured using the instrumented treadmill

During the intervention (periprocedurally)
Kinetic Variable 2: Center-of-pressure Movement
Tidsramme: During the intervention (periprocedurally)

Center-of-pressure movement in antero-posterior and medio-lateral direction (in cm; less is better) measured using the instrumented treadmill

During the intervention (periprocedurally)
Kinetic Variable 3: Velocity
Tidsramme: During the intervention (periprocedurally)

Velocity in antero-posterior and medio-lateral direction (in cm/s; smaller is better) measured using the instrumented treadmill

During the intervention (periprocedurally)

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Metka Močilar, MSc PT, University Rehabilitation Institute, Republic of Slovenia
  • Studieleder: Urška Puh, PT, PhD, University Rehabilitation Institute, Republic of Slovenia

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 (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. november 2028

Studiet fullført (Antatt)

1. november 2029

Datoer for studieregistrering

Først innsendt

30. oktober 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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