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Implementering af terapi i fællesskab

3. oktober 2026 opdateret af: Angela Shierk, Texas Scottish Rite Hospital for Children

Implementering af terapi sammen med staten Texas Early Childhood Intervention Program

The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question[s] it aims to answer are:

  • Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care?
  • Is it feasible to implement the Therapy Together program within the standard care, early intervention framework?

Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.

Therapy Together Program:

The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 sessions with their therapist. The therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • Frisco, Texas, Forenede Stater, 75034
        • Rekruttering
        • Scottish Rite for Children
        • Kontakt:

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

3 måneder til 5 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
  • children ages 3 months to 5 years 11 months
  • present with asymmetric hand use
  • present with a unilateral upper limb impairment
  • able to visually attend to objects
  • demonstrate an interest in objects
  • attempt to reach for or grasp objects with the impaired upper extremity

Exclusion Criteria:

  • uncontrolled epilepsy
  • significant visual impairment
  • severe behavioral problems
  • inability to complete the assessment protocol.

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Therapy Together

Participants will complete the 8-week Therapy Together program.
Adfærdsmæssigt: Therapy Together

8-week caregiver-led pediatric constraint-induced movement therapy program
Aktiv komparator: Usual Care

Participants will complete 8 weeks of usual care in early intervention.
Adfærdsmæssigt: Usual Care

8 weeks of usual care received in an early intervention therapy program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mini-Assisting Hand Assessment
Tidsramme: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Assisting Hand Assessment
Tidsramme: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Hand Assessment for Infants
Tidsramme: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)
baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Canadian Occupational Performance Measure
Tidsramme: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)
baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Developmental Assessment for Young Children, Second Edition (DAYC-2)
Tidsramme: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)
baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Measure of Hand and Arm Performance
Tidsramme: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10
baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pre-training and Post-training Therapist Survey
Tidsramme: Baseline, pre-intervention and within 1 month of post-intervention

The pre-training and post-training survey includes questions on knowledge, appropriateness, and acceptability of pediatric constraint-induced movement therapy (includes likert scale questions, demographic questions, and open ended qualitative responses)
Baseline, pre-intervention and within 1 month of post-intervention
Interviews with therapists and caregivers
Tidsramme: Within 1 month of post intervention

Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data
Within 1 month of post intervention
Weekly Caregiver Log
Tidsramme: weekly for 8 weeks

The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
weekly for 8 weeks
Weekly Therapist Log
Tidsramme: weekly for 8 weeks

Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses
weekly for 8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Texas Scottish Rite Hospital for Children

Samarbejdspartnere

American Occupational Therapy Foundation

Efterforskere

  • Ledende efterforsker: Angela Shierk, PhD, Scottish Rite for Children

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 (Faktiske)

13. november 2023

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

28. august 2023

Først indsendt, der opfyldte QC-kriterier

8. september 2023

Først opslået (Faktiske)

15. september 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU-2023-0553

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