Feasibility of a Remotely Delivered Step Count Intervention in Chronic Stroke (PA-ChatS)
9. juni 2026 opdateret af: University of Minnesota
Feasibility of Engaging Stroke Survivors in a Brief Step Count Intervention During Chronic Stroke
The goal of this study is to explore the feasibility of a new approach to rehabilitation that focuses on step count.
Participants will complete 6 telephone or Zoom-based sessions with an occupational therapist over 6 weeks and use a step count tracker during that time.
They will also complete questionnaires, assessments, surveys, and physical activity measurements during study weeks 0 (baseline), 3 (mid-point), 7 (post-intervention) and 12 (follow-up).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Karli Jahnke
- Telefonnummer: 612-626-4046
- E-mail: dwell@umn.edu
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Stroke diagnosis confirmed by imaging
- Stroke occurred 6 or more months before study enrollment
- Meet criteria for "inactive" on the International Physical Activity Questionnaire-Short Form
- Able to identify a support person that they interact with in-person at least once per week
- Able and willing to participate fully in the study and provide informed consent or proxy consent with participant assent
Exclusion Criteria:
- Currently receiving care in a transitional care unit, skilled nursing facility, or other institutional care setting
- Currently receiving outpatient neurorehabilitation services (e.g., physical therapy, occupational therapy, speech therapy)
- Severe cognitive or communication impairments (inability to respond accurately to complete study screening questions or to provide informed consent or assent)
- Currently pregnant or expecting to become pregnant in the next 8 weeks Comorbid neurological disorder (Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma, spinal cord injury, cerebral palsy)
- Comorbid cancer, currently undergoing chemotherapy or radiation treatment
- Received inpatient treatment or was hospitalized for a psychiatric condition and/or alcohol or substance abuse within the past 12 months
- Current diagnosis of a terminal illness and/or currently receiving hospice care
- History of allergic reaction to adhesives that precludes the use of an adhesive necessary for adherence to activPAL measurement
- Uses wheelchair as primary mobility aid outside of home setting
- Inability to speak, read, or understand English
- Concurrent participation in another rehabilitation intervention research study
- Resides more than 50 miles outside of the Twin Cities, Minnesota metropolitan area
- Investigator discretion for safety or adherence reasons
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: PA-ChatS Intervention
Participants will receive 6, 20-30 minute intervention sessions delivered over the telephone or using Zoom by an occupational therapist over 6 weeks (1 session/week).
They will also complete self-monitoring of step counts using a pedometer.
|
PA-ChatS consists of (1) self-monitoring step count using a pedometer, and (2) behavioral activation for stepping activity delivered via the telephone or Zoom and guided by the PA-ChatS workbook. Participants will receive education regarding physical activity after stroke, American Heart Association guidelines for post-stroke physical activity levels, and an overview of the intervention activities. They will then use a pedometer to monitor average daily step counts, set new step count goals (increasing by 5 to 10% of the daily average step count from the prior week), and create a specific plan for achieving the new step count goal. The interventionist will collaboratively problem solve with the participant to identify strategies to overcome barriers to stepping activity and maintain safety. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence to step count
Tidsramme: Week 7
|
The activPAL micro4 (24/7 wear protocol) will used to measure step count.
The proportion of participants achieving 7500 or more steps per day will be reported.
|
Week 7
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overholdelse af PA-ChatS sessioner
Tidsramme: 6 uger
|
Procentdel af deltagere, der gennemfører 6 ud af 6 (100 %) af PA-ChatS-sessioner.
Sessionsafslutning vil blive dokumenteret af undersøgelsens interventionsterapeut, og det samlede antal gennemførte sessioner vil blive beregnet efter den sidste interventionssession er leveret.
|
6 uger
|
|
Acceptabel PA-ChatS-intervention
Tidsramme: Uge 7
|
Kundetilfredshedsspørgeskema-8 vil blive brugt til at måle interventionens accept.
Dette er et mål med 8 elementer, hvor hvert element er vurderet på en 1 til 4-punkts Likert-skala, og derefter gennemsnittet på tværs af alle 8 elementer.
En gennemsnitlig score på 3 eller mere indikerer, at interventionen generelt er acceptabel.
|
Uge 7
|
|
Ændring i skridtantal
Tidsramme: Uge 1 til 12
|
ActivPAL micro4 vil blive brugt til at måle skridttæller efter en 24-timers, 7-dages slidprotokol.
|
Uge 1 til 12
|
|
Ændring i stillesiddende tid
Tidsramme: Uge 1 til 12
|
ActivPAL micro4 vil blive brugt til at måle stillesiddende tid efter en 24-timers, 7-dages slidprotokol.
Deltagerne vil udfylde en daglig dagbog, der angiver søvntiden.
Søvn vil blive fjernet efter en dagbogsinformeret metode.
|
Uge 1 til 12
|
|
Safety of the PA-ChatS Intervention
Tidsramme: Week 7
|
All participants will be queried regarding possible adverse events during the study at one time-point using an adverse events questionnaire previously administered in physical activity studies after stroke.
|
Week 7
|
|
Adherence to step count
Tidsramme: Week 12
|
The activPAL micro4 (24/7 wear protocol) will used to measure step count.
The proportion of participants achieving 7500 or more steps per day will be reported.
|
Week 12
|
|
Change in sedentary time
Tidsramme: Weeks 1 to 7
|
The activPAL micro4 will be used to measure sedentary time, following a 24-hour, 7-day wear protocol.
Participants will complete a daily diary indicating the sleep time.
Sleep will be removed following a diary-informed method.
|
Weeks 1 to 7
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Emily Kringle, PhD, OTR/L, University of Minnesota
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)
22. juni 2026
Primær færdiggørelse (Anslået)
30. november 2026
Studieafslutning (Anslået)
1. januar 2027
Datoer for studieregistrering
Først indsendt
9. juni 2026
Først indsendt, der opfyldte QC-kriterier
9. juni 2026
Først opslået (Faktiske)
16. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00028280
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data related to demographics, medical and stroke history, cognitive function, mobility, self-reported psychosocial and social support measures, and physical activity data may be requested
IPD-delingstidsramme
Deidentified data and supporting documents will be made available upon reasonable request after the main results are published in a peer-reviewed journal.
IPD-delingsadgangskriterier
Requests for data sharing may be directed to the Principal Investigator.
Deidentified IPD and supporting documents will be provided upon reasonable request through appropriate channels (Data Use Agreement).
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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