Gemeinsame Therapiedurchführung
Implementierung der Therapie zusammen mit dem Frühkindlichen Interventionsprogramm des Bundesstaates Texas
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Angela Shierk, PhD
- Telefonnummer: 1045 (469) 412-7172
- E-Mail: angela.shierk@tsrh.org
Studieren Sie die Kontaktsicherung
- Name: Heather Roberts, PhD
- Telefonnummer: (214) 794-8117
- E-Mail: hroberts3@twu.edu
Studienorte
-
-
Texas
-
Frisco, Texas, Vereinigte Staaten, 75034
- Rekrutierung
- Scottish Rite for Children
-
Kontakt:
- Angela Shierk, PhD
- Telefonnummer: 469-412-7172
- E-Mail: angela.shierk@tsrh.org
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Therapy Together
Participants will complete the 8-week Therapy Together program. |
8-week caregiver-led pediatric constraint-induced movement therapy program |
|
Aktiver Komparator: Usual Care
Participants will complete 8 weeks of usual care in early intervention. |
8 weeks of usual care received in an early intervention therapy program |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mini-Assisting Hand Assessment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Canadian Occupational Performance Measure
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pre-training and Post-training Therapist Survey
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Angela Shierk, PhD, Scottish Rite for Children
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STU-2023-0553
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