- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07934849
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
Status
Forhold
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Katja Groleger Sršen, MD, PhD
- Telefonnummer: +386 1 4758283
- E-post: katja.groleger@ir-rs.si
Studiesteder
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Ljubljana, Slovenia, 1000
- University Rehabilitation Institute, Republic of Slovenia
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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 |
|---|---|
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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 |
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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 |
|---|---|---|
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Margin of Stability (MOS)
Tidsramme: During the intervention (periprocedurally)
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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)
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Step Width
Tidsramme: During the intervention (periprocedurally)
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Mean step width measured during walking under different environmental conditions and added tasks, expressed in cm (less is better) |
During the intervention (periprocedurally)
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Step Width Variability
Tidsramme: During the intervention (periprocedurally)
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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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Spatiotemporal Gait Parameter 1: Cadence
Tidsramme: During the intervention (periprocedurally)
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Gait cadence (in steps/min; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
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Spatiotemporal Gait Parameter 2: Step Length
Tidsramme: During the intervention (periprocedurally)
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Gait step length (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
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Spatiotemporal Gait Parameter 3: Stance Time
Tidsramme: During the intervention (periprocedurally)
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Gait stance time (in s, less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
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Spatiotemporal Gait Parameter 4: Swing Time
Tidsramme: During the intervention (periprocedurally)
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Gait swing time (in cm, more is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
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Kinetic Variable 1: Ground Reaction Force
Tidsramme: During the intervention (periprocedurally)
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Ground reaction force in antero-posterior direction (in N; less is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
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Kinetic Variable 2: Center-of-pressure Movement
Tidsramme: During the intervention (periprocedurally)
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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)
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Kinetic Variable 3: Velocity
Tidsramme: During the intervention (periprocedurally)
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Velocity in antero-posterior and medio-lateral direction (in cm/s; smaller is better) measured using the instrumented treadmill |
During the intervention (periprocedurally)
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Metka Močilar, MSc PT, University Rehabilitation Institute, Republic of Slovenia
- Studieleder: Urška Puh, PT, PhD, University Rehabilitation Institute, Republic of Slovenia
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- URIS202602
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