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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.

Studie Overzicht

Gedetailleerde beschrijving

: 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

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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

Actieve vergelijker: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Margin of Stability (MOS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Spatiotemporal Gait Parameter 1: Cadence
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Metka Močilar, MSc PT, University Rehabilitation Institute, Republic of Slovenia
  • Studie directeur: Urška Puh, PT, PhD, University Rehabilitation Institute, Republic of Slovenia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 november 2028

Studie voltooiing (Geschat)

1 november 2029

Studieregistratiedata

Eerst ingediend

30 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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