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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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

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

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

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

Efterforskere

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

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)

1. november 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. november 2029

Datoer for studieregistrering

Først indsendt

30. oktober 2026

Først indsendt, der opfyldte QC-kriterier

6. november 2026

Først opslået (Faktiske)

13. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

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