- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05032911
Sensorimotor Control in People With and Without Neck Pain
Analysis of Sensorimotor Control in People With and Without Neck Pain Using Inertial Sensor Technology: Study Protocol for a Longitudinal Prospective Observational Study
This is a descriptive, observational, longitudinal, prospective study consecutively enrolling patients with non-specific neck pain and age-matched asymptomatic participants.
The investigators will register sensorimotor control variables, including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns. These variables will be recorded by means of Inertial Measurement Unit (IMU) sensors during the following tests consecutively performed in two measuring sessions separated by 12 months: (a) kinematics of planar movements, (b) kinematics of the craniocervical flexion movement, (c) kinematics during functional tasks and (d) kinematics of task-oriented neck movements in response to visual targets.
연구 개요
상태
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Aitor Martin Pintado Zugasti, PhD
- 전화번호: 14691 91 3724700
- 이메일: martinpintado@ceu.es
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Population aged between 18 and 65 years old
Exclusion Criteria:
- Visual impairment not corrected by the use of glasses/contact lenses
- Migraine headache
- Complex regional syndrome
- Previous surgeries in the neck and/or head region
- Sensory and/or vestibular alterations, (f) Otogenic or idiopathic vertigo/dizziness
- Presence of tumors in the craniocervical region
- Previous fracture in the head or neck region
- Osseous deformities in the thoracic, cervical or cranial region
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Asymptomatic participants
Asymptomatic subjects should not present any pain in the cervical region during the last 3 months and no previous treatment for neck pain in order to be included in the study.
|
Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns
|
Neck pain patients
Patients with neck pain should have an intensity of pain of at least 3 points out of 10 on a Visual Analog Scale and a neck pain duration of at least 3 months of evolution.
Neck pain could be from nonspecific mechanical origin, associated with whiplash or with a previous medical diagnosis of degenerative or inflammatory alterations of the cervical spine, associated or not with headache and pain in the shoulder region or the upper limb.
|
Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Active range of motion
기간: 1 year
|
Expressed as an angular displacement (°) in 3 full-movements (flexion-extension, lateral flexion and rotation)
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1 year
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Movement speed
기간: 1 year
|
Expressed as angular velocity (°/sec) in 3 full-movements (flexion-extension, lateral flexion and rotation)
|
1 year
|
Smoothness of motion
기간: 1 year
|
expressed as movement jerk (º/sec3)
|
1 year
|
Head repositioning accuracy
기간: 1 year
|
Calculated as the repositioning error considering the difference between the neutral starting position and the following positions reached after the performance of any of the movements
|
1 year
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Motion coupling patterns
기간: 1 year
|
Calculated as the angular displacement occurring in a different anatomical plane to the one that is being tested for each of the planar movements
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physical activity level
기간: 1 year
|
Measured using the short version of the International Physical Activity Questionnaire (IPAQ).
The score of the scale is expressed in MET level x minutes of activity/day x days per week.
Levels of 3.3 METs are considered light, 4.0 METs are moderate and 8.0 METs are vigorous.
|
1 year
|
Fear of movement and injury
기간: 1 year
|
Measured using the Tampa Scale for Kinesiophobia (TSK-11).
It consists of 11 questions scored from 1 to 4. Therefore, a score of 11 is the lowest possible level of kinesiphobia, while 44 is the highest.
|
1 year
|
Pain-related fear-avoidance
기간: 1 year
|
Measured using the Fear Avoidance Components Scale (FACS).
It has 20 itemsmeasured on a 6-point Likert scale for total possible score of 100 and the lowest possible score of 0. Higher scores indicate higher levels of fear avoidance.
|
1 year
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
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