- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03232879
Combining Motor Imagery With Action Observation Does Not Lead to a Greater Autonomic Response Than Motor Imagery Alone During Simple and Functional Movements: a Randomized Controlled Trial.
연구 개요
상세 설명
Motor Imagery (MI) is defined as a dynamic mental process that involves the representation of an action, in an internal way, without its actual motor execution. The Action Observation (AO) evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both mental processes trigger the activation of the neurocognitive mechanisms that underlie the planning and execution of voluntary movements in a manner that resembles how the action is performed in a real manner.
Both observation and imagination share a great number of common mental processes based primarily on sensory perception, and the information stored by memory systems. The activation of the motor command during a mental practice does not induce an active movement probably due to an inhibitory mechanism in the primary motor cortex on the descending corticospinal tract pathways. However, this inhibition is not complete, for it is well known that the training of mental practice involves a component of the autonomic nervous system (ANS).
It has been shown that both MI and AO lead to changes in the ANS that cause excitatory sympathetic responses, although the neurophysiological bases remain uncertain and are still based on hypotheses. The functional relations between both neurocognitive processes and the sympathetic-excitatory nervous system (SNS) could be based on a preparation phase in which, the activation of the SNS, happens to a near effort and, therefore, to a close energy expenditure in physiological processes (i.e., cardiorespiratory adaptationse) which will take place in order to face said metabolic changes produced by the voluntary movement itself. In addition, several hypotheses have been described regarding the notion that the SNS not only has the quantitative objective of providing energy to the muscle effectors, but that it also qualitatively and specifically designs and adapts the parameters on demand in an attempt to save the energy provided for each precise motor execution.
Taking into account that both MI and AO cause sympathetic-excitatory changes that induce an increase in heart rate, blood pressure, respiratory rate, electrodermal activity , our hypothesis is that the combination of MI and AO induces an autonomic sympathetic-excitatory shift greater than MI does in isolation. Therefore, the main objective of this study was to compare the results obtained from intervention groups on the subject of the activation of the SNS in a program that combined MI with AO, in contrast to an isolated MI program on the one hand in asymptomatic subjects and in the other hand in patients with chronic low back pain.. The secondary objective of the present study was to explore whether there is any relationship between the sympathetic-excitatory response and the ability to generate motor imagery, the mental chronometry, and the level of physical activity.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Madrid, 스페인, 28023
- CSEU La Salle
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria asymptomatic subjects:
- Age between 18 and 60
- Healthy and with no pain subjects
Inclusion Criteria patients with chronic low back pain:
- Low back pain for at least the prior 3 months
- Low back pain of nonspecific nature
- Age between 18 and 60
- Low back pain for at least 10 days per month
- Intensity of pain of between 3 and 10 on the Visual Analogue Scale
Exclusion Criteria asymptomatic subjects:
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
- Underage subjects
- Subjects with pain at the time of the study.
Exclusion Criteria patients with chronic low back pain:
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
- Underage subjects
- Having undergone back surgery
- Specific spinal pathology
- Recent trauma
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Experimental 1
Motor Imagery
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Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
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실험적: Experimental 2
Action Observation
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Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
Before the subjects performed the mental MI practice, they were presented with a 30 seconds video that displayed the task that they ought to imagine later.
A video was played prior to the first practice of imagination and after the second mental practice, a second video was shown.
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간섭 없음: 대조군
개입 없음
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Electrodermal Activity
기간: Change in electrodermal activity after 5 minutes post-intervention
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Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand
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Change in electrodermal activity after 5 minutes post-intervention
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Respiration Rate
기간: Change in respiration rate after 5 minutes post-intervention
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Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap
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Change in respiration rate after 5 minutes post-intervention
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Heart Rate
기간: Change in heart rate after 5 minutes post-intervention
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Heart Rate will be measured by three electrodes located in the left area of the chest.
One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode.
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Change in heart rate after 5 minutes post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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시각 및 운동감각 운동 심상 능력
기간: 사전 개입
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시각 및 운동감각적 운동 이미지 능력은 MIQ-R 설문지로 측정됩니다.
MIQ-R에는 두 가지 하위 척도(시각적 및 운동감각적 척도)에서 반복되는 4가지 움직임이 있습니다.
또한 1에서 7 사이의 점수가 부여되며, 1은 모터 이미지를 그리는 어려움 또는 이전에 이루어진 움직임을 느끼는 어려움을 나타내고 7은 최대 용이함을 나타냅니다.
MIQ-R에서 수정이 이루어졌습니다.
작은 점프를 하는 항목 2와 5는 발끝으로 서 있는 것으로 변경되었습니다.
MIQ-R의 내부 일관성은 총 척도의 경우 0.84, 시각 하위 척도의 경우 0.80, 운동감각 하위 척도의 경우 0.84 이상의 Cronbach's α 계수로 일관되게 적절했습니다.
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사전 개입
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정신 크로노메트리
기간: 사전 개입
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Mental chronometry 평가는 또한 주제의 운동 이미지 능력을 측정하는 데 사용되었습니다.
스톱워치를 사용하여 각 MIQ-R 작업을 수행하는 데 소요된 시간을 기록했습니다.
기록된 시간은 평가자가 과제를 시작하라는 명령과 피험자가 과제 완료에 대한 구두 응답 사이의 간격에 해당합니다.
Mental chronometry는 이전에 MI 능력의 객관적인 척도를 수집하기 위해 사용된 신뢰할 수 있는 행동 작업입니다.
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사전 개입
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신체 활동 정도
기간: 사전 개입
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신체활동의 정도는 The International Physical Activity Questionnaire 설문지를 통해 객관화하였으며, 피험자는 활동 수준에 따라 높음, 보통, 낮음 또는 비활성으로 세 그룹으로 나눌 수 있습니다.
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사전 개입
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .
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