一緒に治療を実践する
テキサス州幼児期介入プログラムと連携した治療の実施
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.
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Angela Shierk, PhD
- 電話番号：1045 (469) 412-7172
- メール：angela.shierk@tsrh.org
研究連絡先のバックアップ
- 名前：Heather Roberts, PhD
- 電話番号：(214) 794-8117
- メール：hroberts3@twu.edu
研究場所
-
-
Texas
-
Frisco、Texas、アメリカ、75034
- 募集
- Scottish Rite for Children
-
コンタクト：
- Angela Shierk, PhD
- 電話番号：469-412-7172
- メール：angela.shierk@tsrh.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Therapy Together
Participants will complete the 8-week Therapy Together program. |
8-week caregiver-led pediatric constraint-induced movement therapy program |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mini-Assisting Hand Assessment
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Canadian Occupational Performance Measure
時間枠：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)
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pre-training and Post-training Therapist Survey
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Angela Shierk, PhD、Scottish Rite for Children
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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