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ASD 청소년의 정신과 집단에서 치료적 승마 개입 효과의 생리학적 기전

2026년 7월 24일 업데이트: University of Colorado, Denver

자폐 스펙트럼 장애를 가진 청소년의 정신과 집단에서 즉각적이고 장기적인 치료적 승마 개입 효과와 관련된 작용의 생리학적 메커니즘

이 무작위 통제 시험(RCT)은 이전에 관찰된 치료 승마(THR)의 기본 메커니즘을 평가하고 ASD 청소년, 특히 ​​동시 발생 정신 장애가 있는 청소년에게 유의미한 긍정적 효과를 평가하고 내구성, 용량 및 하위 모집단에 대한 정보를 개선하고자 합니다. 개입의 효과.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

이 무작위 통제 시험(RCT)은 타액 코티솔, 심혈관 및 피부 전기 활동의 생리적 반응 패턴이 이전에 관찰된 중요한 결과(예: 과민성 및 과잉 행동 감소, 사회적 및 의사 소통 개선) 및 추가 결과를 설명한다는 가설을 테스트합니다. 감정 조절 간병인 삶의 질 및 위기 정신 건강 관리 사용), 6-16세 청소년. ASD 및 공동 발생 정신과 진단을 통해 10주 수동 THR 개입에 무작위로 배정하고 무말 헛간 활동(BA) 통제(목표 1)와 비교했습니다. 개입 기간(목표 2) 6개월 후 BA 대조군과 비교하여 THR 그룹에서 목표 1 결과의 내구성을 평가할 것입니다. 마지막으로, 우리는 THR 및 BA 그룹의 효과 크기 차이를 (a) 10주 대기 목록 대조군 그룹과 비교하여 THR 및 BA 개입의 용량 및 하위 모집단 효과를 탐색할 것입니다. (b) 하이브리드 개입 그룹(BA 5주 후 THR 5주); 및 (c) 정신과 입원 후 무작위화된 THR 연구 모집단의 하위 표본(목표 3).

연구 유형

중재적

등록 (실제)

236

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 미국
    • Colorado
      • Aurora, Colorado, 미국, 80218
        • University of Colorado Anschutz Medical Campus
    • Maine
      • Portland, Maine, 미국, 04102
        • Maine Health

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

6년 (어린이)

건강한 자원 봉사자를 받아들입니다

예

설명

포함 기준:

  • 문서화 된 ASD 진단 및 동시 발생 정신 장애
  • ABC 과민성 하위 척도 점수 ≥8
  • 라이터-III 비언어적 IQ ≥ 40
  • 증상 기준 점수 충족(CASI-5에서 DSM-V(기분, 불안 또는 ADHD 진단)에 필요한 최소 증상 수)
  • SCQ(≥ 11) 및 ADOS-2에서 ASD 컷오프 충족
  • 독립적인 관찰을 유지하기 위해 가족당 ASD가 있는 아동 한 명만
  • 연구 결과 측정을 완료하기 위한 일관된 간병인(즉, 부모 또는 법적 보호자)

제외 기준:

  • 참여를 방해하는 의료 또는 행동 문제
  • 국가의 병동
  • 라이딩 센터 화면에서 상당한 라이딩 경험이 있다고 판단되는 자
  • 코티솔 수치에 영향을 미치는 것으로 알려진 요인인 흡연 또는 정기적인 경구, 흡입 또는 국소 스테로이드 사용
  • 200파운드 이상의 참가자는 승마 센터의 안전 정책으로 인해 제외됩니다.
  • 참가자는 THR 효과의 6개월 유지에 대한 파일럿 증거를 고려할 때 마운트된 EAAT에 마지막으로 참여한 시점으로부터 최소 6개월이 지날 때까지 기본 평가를 시작할 수 없습니다.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 대기자 명단
대기자 명단에 배정된 사람들은 10주 대기 기간 동안 말과 관련된 개입을 받지 않습니다. 이 대기 기간과 사후 평가 완료 후 이 상태의 참가자는 하이브리드 그룹을 시작합니다(하이브리드 암 참조).
실험적: 치료 승마
이 Arm은 THR 강사가 이끄는 10주 1시간 소그룹(2-4명의 참가자)입니다. 그룹에는 연구의 THR 매뉴얼인 에 설명된 대로 승마 기술을 배우기 위한 45분 간의 마상 활동이 포함됩니다. 타액 코르티솔을 수집하는 그룹 시간은 오후 1시~5시 사이입니다. 매주 참가자들은 전기 피부 활동과 심박수 모니터링 장치를 모두 착용하는 일관된 루틴을 따르고 수업 전에 그룹 미술 테이블에 앉습니다. 그 후 연구 담당자는 참가자들에게 10cm 길이의 폼 면봉 막대를 혀 아래에 두도록 지시합니다. 1분 타이머를 보면서 1분. 참가자들은 승마용 헬멧을 착용하고 승마장에 입장합니다. 매주 THR 개입이 끝난 후 참가자들은 그룹과 함께 5분 동안 미술 테이블에 다시 앉아 타액 샘플을 다시 채취하게 됩니다.
다른: 치료 승마
말 치료
다른 이름들:
  • 말 보조 활동
활성 비교기: 헛간 활동
이 Arm은 THR 강사가 주도하고 정신 건강 또는 작업 치료 제공자가 공동 주도하는 10주 1시간 소그룹(참가자 2~4명)입니다. 참가자에게는 한 명의 자원봉사자가 배정되며 승마 센터에서는 말과 신체적 접촉이 없으며 멀리서 말을 볼 수 있습니다. BA 학습 매뉴얼에 따라 주간 주제와 관련된 실습 학습을 위한 실물 크기의 말 인형이 제공됩니다. 타액 코르티솔을 수집하는 그룹 시간은 오후 1시~5시 사이입니다. 매주 참가자들은 전기 피부 활동과 심박수 모니터링 장치를 모두 착용하는 일관된 루틴을 따르고 수업 전에 그룹 미술 테이블에 앉습니다. 그 후 연구 담당자는 참가자들에게 10cm 길이의 폼 면봉 막대를 혀 아래에 두도록 지시합니다. 1분 타이머를 보면서 1분. BA 개입이 끝난 후 매주 참가자들은 그룹과 함께 5분 동안 미술 테이블에 앉아 또 다른 타액 샘플을 채취하게 됩니다.
다른: 헛간 활동
승마 그룹
다른 이름들:
  • 말 컨트롤 없음
실험적: 잡종
대기자 명단 Arm 및 사후 평가를 완료한 참가자는 오후 1시~5시 사이에 하이브리드 그룹을 시작합니다. 이 그룹은 THR 강사가 주도하고 정신 건강 상담사 또는 OT가 공동 주도하는 5주 1시간 BA 소그룹(참가자 2~4명)으로 구성됩니다. 참가자에게는 한 명의 자원봉사자가 배정되며 승마 센터에서는 말과 신체적 접촉이 없으며 단지 멀리서 말을 볼 수 있습니다. BA 학습 매뉴얼에 따라 매주 주제를 직접 학습할 수 있는 실물 크기의 말 인형이 제공됩니다. 그룹. 그런 다음 참가자는 THR 강사가 이끄는 5주간의 치료 승마 소그룹(2~4명 참가자)을 완료하게 됩니다. 이 그룹에는 THR 매뉴얼에 따라 승마 기술을 배우기 위한 45분간의 말 타기 활동과 이어서 15분간의 말에서 내리지 않은 말 손질 및 태클 활동이 포함됩니다. 참가자에게는 배정된 말과 자원봉사자가 배정됩니다.
다른: 잡종
지상 및 승마 활동
다른 이름들:
  • 말 보조 활동

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Aberrant Behavior Checklist-Community (ABC-C) - Baseline
기간: Baseline
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
Baseline
Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
기간: End of Treatment
The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
End of Treatment
Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
기간: 6 months post intervention
The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e. Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale. THIS MEASURE DOES NOT GENERATE A TOTAL SCORE. Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems. The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
6 months post intervention
Social Responsiveness Scale™, Second Edition - End of Treatment
기간: End of Treatment
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
End of Treatment
Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
기간: 6 months post intervention
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. THIS STUDY USED RAW SCORES FOR ANALYSES. FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME. Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26. Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
6 months post intervention
Emotion Dysregulation Inventory (EDI) - Baseline
기간: Baseline
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
Baseline
Emotion Dysregulation Inventory (EDI) - End of Treatment
기간: End of Treatment
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
End of Treatment
Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
기간: 6 months post intervention
The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately. The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions. The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness. For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here). The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
6 months post intervention
Systematic Analysis of Language Transcripts (SALT) - Baseline
기간: Baseline
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
Baseline
Systematic Analysis of Language Transcripts (SALT) - End of Treatment
기간: End of Treatment
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
End of Treatment
Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
기간: 6 months post treatment
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD. The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database. A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment. Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
6 months post treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
기간: Baseline
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
Baseline
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
기간: End of Treatment
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here. Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
End of Treatment
World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
기간: 6 months post intervention
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale. Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items). Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
6 months post intervention
Social Responsiveness Scale™, Second Edition - Baseline
기간: Baseline
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD. The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors). NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES. The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134. HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES. The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19. HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES. The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28. HIGHER SCORES ON THIS SUBSCALE.
Baseline

기타 결과 측정

결과 측정
측정값 설명
기간
Salivary Cortisol - Baseline Baseline
기간: Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed separately.
Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
Salivary Cortisol - Mid-Point
기간: Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.
Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
Salivary Cortisol - End of Treatment
기간: Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10. Salivary cortisol collected pre- and -post intervention activities were analyzed.
Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
Heart Rate Variability - Baseline
기간: Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.
Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
Heart Rate Variability - Mid-point
기간: Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.
Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
Heart Rate Variability - End of Treatment
기간: Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
The Shimmer3 cardiac (ECG) monitor was used in this study. This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion. The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively. It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125 It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing. Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson. Unit of measure is ms log-10 transformed.
Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
Electrodermal Activity -- Baseline
기간: Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured during the intervention lesson. Unit of measure is microsiemens.
Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
Electrodermal Activity - Mid-point
기간: Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.
Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
Electrodermal Activity - End of Treatment
기간: Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes. As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used. EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range. Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile. The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry. Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson. Unit of measure is microsiemens.
Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Colorado, Denver

협력자

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Boston Children's Hospital
Baylor University
Colorado State University
Riding To The Top Therapeutic Riding Center
Hearts and Horses Therapeutic Riding Center
Salimetrics, LLC
Maine Health/Spring Harbor Hospital

수사관

  • 수석 연구원: Robin L Gabriels, Psy.D., University of Colorado Anzchutz Medical Campus

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)

2020년 12월 22일

기본 완료 (실제)

2025년 2월 22일

연구 완료 (실제)

2025년 2월 22일

연구 등록 날짜

최초 제출

2020년 10월 15일

QC 기준을 충족하는 최초 제출

2020년 10월 22일

처음 게시됨 (실제)

2020년 10월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 24일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 19-1962
  • 1R01HD097693-01A1 (미국 NIH 보조금/계약)

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. .

구독하다