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뇌성마비의 유아기 구속 치료에서의 원격의료 (APPLES-TELE)

2026년 11월 2일 업데이트: Nathalie Maitre, Emory University

This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Cerebral palsy (CP) is a disorder characterized by impairments of sensorimotor function resulting from neural insults in the perinatal period. Every year almost 10,000 children are born with CP in the US. CP incidence ranges from 2 to 3 per 1000 in North America, Australia, and Europe and is difficult to estimate in the developing world. Intervention strategies to promote function of children with CP must be adaptable to settings where resources or access may be limited, yet simultaneously integrate best clinical evidence and neuroscientific principles. Upper extremity (UE) impairments are present in a significant portion of children with CP, some with hemiplegia (~25% children with CP), and others with quadriplegia, in which one arm and hand may be more affected than the other (another ~25%). UE impairments in CP result from a combination of motor and sensory dysfunctions including a lack of high-quality motor experience, which combined with "noisy" (often faulty) sensory input, challenges the acquisition of new effective motor patterns.

Among the various approaches to improve UE function in infants with CP are constraint-induced movement therapy (the use of constraints on less affected limbs) and bimanual therapy (training of both extremities in coordination). Brief sessions of parent-delivered, infant-initiated, goal-directed, success-motivated and repetitive activity in enriched sensory environments can be effective, while respecting fundamental principles of infant development and home life. Parent administration of the intervention helps preserve the integrity of early parent-child relationships, critical to establishment of infants' sense of self, safety, and independence.

Finally, to take full advantage of neuroplasticity and maximize potential downstream developmental effects, it is essential to intervene as early as possible in children with CP. Promising new treatments such as transcranial magnetic stimulation, robotic-assisted movements and technology enhancements to movement feedback are in development. However, these interventions require substantial investments of highly-skilled therapists, technology, infrastructure and access to academic facilities. While the new interventions advance the cutting-edge of motor intervention development, on another leading edge, parent-delivered therapist-directed telehealth interventions are becoming more widespread, addressing a critical need for lower-resource interventions.

Healthcare systems resources are limited, and can be difficult to access due to geographic and socioeconomic obstacles. While telehealth therapy seems eminently practical, and a natural extension of current interventions for infants with CP, it faces its own scientific challenges. The same essential attributes of physical therapy that make it so effective in person can make it difficult to deliver via telehealth. Telehealth therapy in infants requires a level of parent engagement, knowledge and parenting skills that is sometimes lacking. Feasible telehealth interventions to improve function in infants with CP must also address the challenges faced by their parents in conducting the sessions through effective parenting supports.

In this study, infant participants with CP will be randomized to one of three treatment groups:

  1. The APPLES intervention via telehealth (APPLES-tele) followed by a parent-centered approach (PCA) intervention
  2. The PCA intervention followed by the APPLES-tele intervention
  3. The standard of care

Outcome measures will be standardized assessments of hand/arm function and validated parent-report measures of infant motor activity.

연구 유형

중재적

등록 (실제)

269

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • Emory University
    • Maryland
      • Baltimore, Maryland, 미국, 21205
        • Kennedy Krieger Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Children's Hospital of Philadelphia
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • The University of Utah

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

4개월 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Aged 4 to 13 months, corrected age
  • Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)
  • Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
  • Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands >1
  • Parent/legal guardian is able to provide informed consent

Exclusion Criteria:

  • Congenital malformation of the brain or musculoskeletal system (MSK)
  • Receipt of botulinum toxin to the affected extremity within 3 months of study entry
  • Any prior long-term hard constraint programs

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: APPLES-tele first, then PCA

Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks.

The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.

다른 이름들:
  • C-미트

The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.

실험적: PCA first, then APPLES-tele

Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks.

The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.

다른 이름들:
  • C-미트

The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.

활성 비교기: Standard of Care Control Arm

Participants receiving the standard of care for 6 weeks.

Participants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score
기간: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function of the more affected upper extremity is assessed using the 54 unimanual items of the Bayley-3 instrument. Responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total unimanual fine motor raw scores for the more affected arm range from 0 to 108 where higher scores indicate greater fine motor function.

Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score
기간: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

The Authoritative Parenting Style scale of the Parenting Styles and Dimensions Questionnaire (PSDQ) - short version, includes 15 items that are rated on a 5-point scale where 1 = never and 5 = always. The raw score ranges from 15 to 75 and higher scores indicate a more expression of the authoritative parenting style.

Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

2차 결과 측정

결과 측정
측정값 설명
기간
Infant Motor Activity Log (IMAL) How Often Score
기간: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)

Parent perception of hand performance is assessed with the IMAL. The IMAL includes 20 items asking caregivers how often and how well the infant uses their less preferred hand. Responses are given on a 5-point Likert scale where 0 = not used and 5 = normal use. Raw scores on how often the infant uses their less preferred hand range from 0 to 100, with higher scores indicating more normal hand usage.

Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Hand Assessment in Infants (HAI) Score
기간: Baseline, Week 6 (after the first intervention)

The HAI is an assessment evaluating quality and frequency of hand abilities in infants 3 to 12 months corrected age using a semi-structured 12-15 min videotaped play session that is scored by a certified therapist. There are 12 unimanual and 5 bimanual items, each is scored on a 3-point rating scale, of 0, 1, or 2 points. Each hand receives a raw score based upon performance on the unimanual items. The raw score for the more affected hand will be reported as a continuous variable. Total raw scores for the unimanual items range from 0 to 24 and higher scores indicate greater ability.

Baseline, Week 6 (after the first intervention)
Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score
기간: Baseline, Week 6 (after the first intervention)

The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function scale of the Bayley-3 instrument includes 66 items, and responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total fine motor raw scores range from 0 to 132 where higher scores indicate greater fine motor function.

Baseline, Week 6 (after the first intervention)
Welch Emotional Connection Screen (WECS) Score
기간: Baseline, Week 6 (after the first intervention)

The WECS assesses parent-infant connection by examining four emotional connection dimensions of behavior: attraction, vocal communication, facial communication, and sensitivity. Items are rated on a 3-point scale where 1 = low and 3 = high. A WECS Mother (WECS-M) score is created by summing the four items for maternal connection while the four items for infant connection create a WECS Infant (WECS-I) score. Total WECS-M or WECS-I scores range from 4 to 12 where higher scores indicate greater connection.

Baseline, Week 6 (after the first intervention)
Maternal Confidence Questionnaire (MCQ) Score
기간: Baseline, Week 6 (after the first intervention)

The MCQ assesses parent knowledge and confidence in caring for and understanding their infant. The MCQ has 14 items which are scored on a 5-point scale where 1 = never and 5 = a great deal. Scores are reversed for some items and total scores range from 14 to 70. Higher scores indicate greater maternal confidence.

Baseline, Week 6 (after the first intervention)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Nathalie Maitre, MD, PhD, Emory University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 2월 23일

기본 완료 (실제)

2026년 10월 12일

연구 완료 (실제)

2026년 10월 12일

연구 등록 날짜

최초 제출

2021년 8월 4일

QC 기준을 충족하는 최초 제출

2021년 8월 4일

처음 게시됨 (실제)

2021년 8월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • STUDY00003197
  • 2R01HD081120 (미국 NIH 보조금/계약)
  • 2025P011605 (기타 식별자: Emory IRB)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .