Magic Camp for Children With Hemiplegic Cerebral Palsy
2020年2月20日 更新者：Hon K. Yuen, PhD、University of Alabama at Birmingham
The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children with spastic hemiplegic cerebral palsy (CP).
A single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "Magic Camp" on improving upper limb motor function and health-related quality of life (HRQoL) in children with hemiplegic CP.
調査の概要
詳細な説明
This project will employ a single group pretest-posttest design to investigate the impact of a "Magic Camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic CP.
After the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks.
The primary outcome measures will be unimanual function as measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the Children's Hand Experience Questionnaire.
Secondary outcome measures will include HRQoL as measured by the Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.
研究の種類
介入
入学 (実際)
7
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
9年～18年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- spasticity with Modified Ashworth Scale grades between 1 and 3;
- ability to lift the more affected arm 15 cm above a table surface;
- impairment of hand function at levels I to III of the Manual Activity Classification System
- ability to grasp and release light objects with the more affected hand
- largely nonuse of the more affected hand in daily activities as determined by the Pediatric Motor Activity Log
- are interested in learning magic tricks
- have the cognitive and social ability to participate in a camp setting;
- ability to follow directions in English; and
- ability to remember simple sequences of actions to perform magic tricks.
Exclusion Criteria:
- severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use
- dystonia
- severe visual or auditory disorders that prevent learning and carrying out the magic tricks
- serious or recurring medical complications
- participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months
- start muscle relaxant within the last 3 months; or
- plan to move to another state within the next 6 months.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 介入モデル：単一グループの割り当て
- 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：Magic camp intervention
These children are diagnosed with cerebral palsy and we will provide motor control training.
|
Hand-arm bimanual motor skills training
|
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 |
|---|---|---|
|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
時間枠：baseline
|
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by occupational therapy (OT) students to assess the efficiency of unimanual grasp and release of items with six tasks.
Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills
|
baseline
|
|
Bimanual coordination as measured by 3-D kinematic motion analysis
時間枠：baseline
|
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal.
Each trial ends when the button is pressed.
Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.
Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
|
baseline
|
|
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
時間枠：Baseline
|
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required.
Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items.
Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
|
Baseline
|
|
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
時間枠：Baseline
|
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being.
Items are rated on a 9-point scale, and recoded and transformed into scaled scores (transformed to a scale of 1-100) for each domain.
An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted.
Higher scores represent better health-related quality of life.
|
Baseline
|
|
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
時間枠：Baseline
|
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample.
Nail samples will be sent to the Bio-Analytical Redox Biology (BARB) Core Laboratory, University of Alabama at Birmingham (UAB) for analysis.
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
時間枠：from baseline to two weeks
|
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by OT students to assess the efficiency of unimanual grasp and release of items with six tasks.
Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills.
|
from baseline to two weeks
|
|
Bimanual coordination as measured by 3-D kinematic motion analysis
時間枠：from baseline to two weeks
|
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal.
Each trial ends when the button is pressed.
Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
|
from baseline to two weeks
|
|
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
時間枠：from baseline to two weeks
|
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required.
Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items.
Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
|
from baseline to two weeks
|
|
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
時間枠：from baseline to two weeks
|
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being.
Items are rated on a 9-point scale, and recoded and transformed into scaled scores for each domain.
An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted.
Higher scores represent better health-related quality of life.
|
from baseline to two weeks
|
|
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
時間枠：from two weeks to three months
|
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by OT students to assess the efficiency of unimanual grasp and release of items with six tasks.
Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills.
|
from two weeks to three months
|
|
Bimanual coordination as measured by 3-D kinematic motion analysis
時間枠：from two weeks to three months
|
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal.
Each trial ends when the button is pressed.
Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials.
Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
|
from two weeks to three months
|
|
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
時間枠：from two weeks to three months
|
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required.
Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items.
Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
|
from two weeks to three months
|
|
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
時間枠：from two weeks to three months
|
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being.
Items are rated on a 9-point scale, and recoded and transformed into scaled scores for each domain.
An average of the scale scores from all domains (family & friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted.
Higher scores represent better health-related quality of life.
|
from two weeks to three months
|
|
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
時間枠：from baseline to three months
|
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample.
Nail samples will be sent to the BARB Core Laboratory, UAB for analysis.
|
from baseline to three months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Hon K Yuen, PhD、University of Alabama at Birmingham
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年6月4日
一次修了 (実際)
2018年10月1日
研究の完了 (実際)
2018年12月31日
試験登録日
最初に提出
2018年8月2日
QC基準を満たした最初の提出物
2018年8月2日
最初の投稿 (実際)
2018年8月8日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月24日
QC基準を満たした最後の更新が送信されました
2020年2月20日
最終確認日
2020年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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