Wspólna realizacja terapii
Wdrożenie terapii wraz z programem wczesnej interwencji stanu Teksas
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Angela Shierk, PhD
- Numer telefonu: 1045 (469) 412-7172
- E-mail: angela.shierk@tsrh.org
Kopia zapasowa kontaktu do badania
- Nazwa: Heather Roberts, PhD
- Numer telefonu: (214) 794-8117
- E-mail: hroberts3@twu.edu
Lokalizacje studiów
-
-
Texas
-
Frisco, Texas, Stany Zjednoczone, 75034
- Rekrutacyjny
- Scottish Rite for Children
-
Kontakt:
- Angela Shierk, PhD
- Numer telefonu: 469-412-7172
- E-mail: angela.shierk@tsrh.org
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Therapy Together
Participants will complete the 8-week Therapy Together program. |
8-week caregiver-led pediatric constraint-induced movement therapy program |
|
Aktywny 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mini-Assisting Hand Assessment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Canadian Occupational Performance Measure
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pre-training and Post-training Therapist Survey
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Angela Shierk, PhD, Scottish Rite for Children
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STU-2023-0553
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .