- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03405181
Effects of the Additional Weight on the Reaching Behavior of Pre Term Infants With Low Birth Weight
2019년 2월 21일 업데이트: Prof. Rodrigo Luiz Carregaro, University of Brasilia
Effects of the Additional Weight on the Reaching Behavior of Preterm Infants With Low Birth Weight: Randomized Controlled Trial
The effects of additional weight on early motor skills of infants have been increasingly studied.
During the reaching behavior, the additional weight has been shown benefits in certain kinematic variables in full term and preterm infants.
There is a growing interest in the study of populations at risk for motor development, especially considering interventions based on functional activities with the purpose of improving the neuromotor control, functional capacity and muscle strength.
The aim of the present study is to investigate the effect of a functional training with additional weight in the reaching behavior of preterm infants with low birth weight and to compare the effects with a full term population.
A controlled and randomized trial will be carried out with full term infants of adequate birth weight and preterm infants with low birth weight at 6 months of chronological or corrected age.
The participants will be recruited by convenience from the charts of a Public Hospital.
Participants will be randomly allocated into four groups: 1) adequate weight placebo group (AWPG); 2) adequate weight intervention group (AWIG); 2) low weight placebo group (LWPG) and 4) low weight intervention group (LWIG). .
The assessor will be blinded (no knowledge of groups allocation).
All infants will undergo a training program of eight sessions (2x/week; 4 weeks).
The AWIG and LWIG will receive the training with an additional weight (characterized by a bracelet with a weight of 20% of the mass of the upper limbs)and the AWPG and LWPG will receive the same training, however, without the additional weight (only the bracelets)..
All infants will be assessed in three different moments: 1) Pre-intervention: baseline, before the start of the intervention program; 2) Post-intervention: evaluation performed after the end of the program; and 3) Follow-up: evaluation performed seven days after the post-intervention assessment.
The following kinematic dependent variables will be calculated: straightness index, mean velocity and motion units and electromyographic variables: pattern of activation and recruitment of muscle fibers - Biceps brachialis, Triceps brachialis, Deltoid and Pectoralis Major muscles; co-activation between biceps and triceps.
The Qualisys Track Manager (QTM) and a wireless surface electromyography with 8-channels will be used.
If normality assumptions are met, a mixed 2X2 ANOVA with repeated measures will be applied, in order to verify differences between the intervention programs, considering the dependent variables.
Otherwise, non-parametric procedures of the same nature will be adopted.
The significance will be set at 5% (P<0.05).
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
66
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
DF
-
Brasília, DF, 브라질, 72220-275
- Campus UnB Ceilandia
-
-
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
6개월 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adequate weight infants: healthy infants born with gestational age between 38-42 weeks and adequate birth weight (> 2500 grams);
- Low weight infants: healthy infants born with gestational age between 32-36 weeks and 6 days and with low birth weight (between 1500 and 2500 grams).
Exclusion Criteria:
- Anoxiated infants;
- Signs of neurological impairment (eg, hypoxic-ischemic encephalopathies grade I, II and III, intracranial hemorrhage and neonatal seizures);
- Congenital malformations (eg myelomeningocele and achondroplasias);
- Syndromes (e.g Down Syndrome);
- Sensorial alterations (visual and auditory);
- Cardiorespiratory difficulties;
- Orthopedic impairments (e.g, congenital clubfoot);
- Apgar below 8 and 10 in the first and fifth minutes, respectively.
- Infants who do not attend any of the evaluations, who do not complete at least 80% of the training or who cry uncontrollably, not allowing at least 10 reachings in the evaluations and training. Those that present intercurrences that may compromise normal neurosensorimotor development (for example, recurrent pneumonia, kidney and intestinal infection).
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 |
|---|---|
|
실험적: Training with additional weight
The infants will be submitted to a reaching behavior training program of 4 weeks, two times per week (totaling 8 sessions).
During this training program, infants will use a bracelet with an additional weight characterized by 20% of the total mass of the upper limb placed on both wrists.
This training will be adopted for the adequate weight intervention group and low weight intervention group.
|
The infants will be positioned in a reclined position.
A bracelet with an additional weight (20% of the total mass of the upper limb) will be placed on both wrists.
The training will happen 2x/week, during 4 weeks (8 sessions).
An object will be used to stimulate the reaching behavior, which will be displayed by the examiner (positioned in front of the infant), and presented in the midline at shoulder height, considering the distance from the arm's length of the infant to the height of the wrist.
The physiotherapist will draw the attention of the infant to the object, moving it momentarily so that the infant perceives it and reaches it.
After reaching, the object will be carefully removed and resubmitted in order to elicit a new movement.
The interval between each presentation will be of approximately 5 seconds.
At least 10 movements will be stimulated.
If the infant does not achieve the 10 reaches within the maximum interval of 15 minutes, the session will be terminated.
|
|
위약 비교기: Training without additional weight
The infants will be submitted to a reaching behavior training program of 4 weeks, two times per week (totaling 8 sessions).
During this training program, infants will use a bracelet without additional weight, placed on both wrists.
This training will be adopted for the adequate weight placebo group and low weight placebo group.
|
The infants will be positioned in a reclined position.
A bracelet without the additional weight will be placed on both wrists.
The training will happen 2x/week, during 4 weeks (8 sessions).
An object will be used to stimulate the reaching behavior, which will be displayed by the examiner (positioned in front of the infant), and presented in the midline at shoulder height, considering the distance from the arm's length of the infant to the height of the wrist.
The physiotherapist will draw the attention of the infant to the object, moving it momentarily so that the infant perceives it and reaches the object.
After reaching, the object will be carefully removed (or picked up) and resubmitted in order to elicit a new movement.
The interval between each presentation of the object will be of approximately 5 seconds.
At least 10 movements will be stimulated.
If the infant does not achieve the 10 reaches within the maximum interval of 15 minutes, the session will be terminated.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Movement unit
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
the number of maximum velocities between two minimum velocities, for which the difference was greater than 1 cm/s
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
|
Electromyographic activity
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
Magnitude of the muscle recruitment during the reaching behavior, measured in microvolts (root mean square - RMS)
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean Velocity
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
the ratio between the distance traveled during the reaching behavior and the duration of the movement
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
|
Straightness Index
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
ratio between the minimal distance that could have been traveled in this trajectory (distance between the initial position of the hand and the object) and the distance traveled by the hand (total trajectory).
The closer is this index to 1, the straighter is the trajectory.
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
|
Grasping
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
categorical variable classified into (a) successful: when the infant was able to grasp the object with one or both hands; and (b) unsuccessful: when the infant touched the object, but did not grasp it
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
|
Muscle coactivation
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
Coactivation between the biceps and triceps muscle during the reaching behavior, measured in percentage (activation of the biceps/activation of the triceps)
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
|
Transport Unit
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
The relative duration of the first movement unit in relation to total duration of reaching
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
|
Deceleration time
기간: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
The time necessary for the infant to decelerate the arm movement so that the hand touches an object.
This period of the duration is measured from the time of appearance of the peak of velocity to the end of the reach.
|
Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Rodrigo Carregaro, PhD, University of Brasilia
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)
2018년 1월 12일
기본 완료 (실제)
2018년 9월 15일
연구 완료 (실제)
2018년 9월 15일
연구 등록 날짜
최초 제출
2018년 1월 12일
QC 기준을 충족하는 최초 제출
2018년 1월 18일
처음 게시됨 (실제)
2018년 1월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 21일
마지막으로 확인됨
2019년 2월 1일
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. .
저체중아에 대한 임상 시험
-
FibroGenAstraZeneca; Astellas Pharma Inc종료됨빈혈증 | 기본 MDS(Very Low, Low 또는 Intermediate IPSS-R with미국, 호주, 벨기에, 독일, 이스라엘, 이탈리아, 대한민국, 러시아 연방, 스페인, 영국, 프랑스, 칠면조, 캐나다, 덴마크, 인도, 폴란드
-
Cancer Institute and Hospital, Chinese Academy...모병내장 위기로 인해 복잡한 HER2-LOW 절제 불가능한/전이성 유방암중국
-
Shanghai Henlius Biotech모병HER2-LOW 호르몬 수용체 양성 유방암중국
-
Yeon Hee ParkHelsinn Healthcare SA초대로 등록T-DXD로 치료 한 HER2 양성 진행 유방암 환자 | T-DXD로 치료 한 HER2-LOW 진행된 유방암 환자대한민국
-
Eisai Inc.완전한LEC(Low Emetogenic Chemotherapy)를 받기 위해 확인된 악성 질환이 있는 환자 또는 LEC의 마지막 주기 동안 최소한 메스꺼움 및 구토를 경험한 환자미국
-
Aminex Therapeutics, Inc.모병