함께하는 치료 시행
텍사스 주 유아 중재 프로그램과 함께 치료 시행
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.
연구 개요
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Angela Shierk, PhD
- 전화번호: 1045 (469) 412-7172
- 이메일: angela.shierk@tsrh.org
연구 연락처 백업
- 이름: Heather Roberts, PhD
- 전화번호: (214) 794-8117
- 이메일: hroberts3@twu.edu
연구 장소
-
-
Texas
-
Frisco, Texas, 미국, 75034
- 모병
- Scottish Rite for Children
-
연락하다:
- Angela Shierk, PhD
- 전화번호: 469-412-7172
- 이메일: angela.shierk@tsrh.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Therapy Together
Participants will complete the 8-week Therapy Together program. |
8-week caregiver-led pediatric constraint-induced movement therapy program |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mini-Assisting Hand Assessment
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Canadian Occupational Performance Measure
기간: 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)
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pre-training and Post-training Therapist Survey
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Angela Shierk, PhD, Scottish Rite for Children
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .