Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Modified Test of Sensory Integration and Balance (MCTSIB) score
研究概览
简要总结
This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.
详细描述
Objective This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.
Methods:
All patients who can stand without severe pain (able to stand normally at a 7 or below on qualitative analog visual pain scale [QVAS]) will be invited to participate. The goal is to recruit 150 participants from approximately 10 chiropractic practices. Volunteers will be given an informed consent document to read and if eligible and willing to participate will sign the informed consent document. At baseline and each subsequent testing visit, participants will complete the following:
- a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain
- Keele STarT Back Screening Tool
- Assessment of Balance Confidence Questionnaire (ABC-6)
- Posture testing via force plate: Modified Test of Sensory Integration and Balance (MCTSIB), Single leg stance, limits of stability,
- Timed up and go and 5 times sit to stand tests The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
研究设计
- 研究类型
- 观察性
- 观察模型
- 其他
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- New patients with spinal pain,
- Patients will be between 18-100 years of age.
- All patients with spinal pain who - can safely stand and perform the basic parameters of the test at a 7 or below on qualitative visual analog scale (QVAS) on pain will be invited to participate.
排除标准
- Patients unable to stand normally with more than a 7 / 10 on the QVAS.
结局指标
主要结局
Modified Test of Sensory Integration and Balance (MCTSIB) score
时间窗: From enrollment to end of 4 weeks and 8 weeks of treatment
MCTSIB is a testing protocol available with BTracks balance system. Patients are asked to stand on a force plate for 20 seconds in four different conditions a) stand on a firm surface with eyes open b) stand on a firm surface with eyes closed c) stand on a foam with eyes open and d) stand on a foam with eyes closed. The path length of the center of pressure movement is quantified with a score. • Center of Pressure (COP) Path Lengths (PLs) under conditions of eyes open (EO), eyes closed (EC), eyes open foam (EOF), and eyes closed foam (ECF); higher values represent worse postural stability
次要结局
- Numerical pain rating scale (0-10) on neck pain, mid-back pain, and low back pain(From enrollment to end of 4 weeks and 8 weeks of treatment)
- Limits of balance while standing on a force plate(From enrollment to end of 4 weeks and 8 weeks of treatment)
- path length of center of pressure while standing on a single leg stance(From enrollment to end of 4 weeks and 8 weeks of treatment)
- Timed up and Go test in seconds(From enrollment to end of 4 weeks and 8 weeks of treatment)
- time to Sit-to-stand test for 5 repetetions(From enrollment to end of 4 weeks and 8 weeks of treatment)
- • Keele STaRT Back(From enrollment to end of 4 weeks and 8 weeks of treatment)
- • Assessment of Balance Confidence Questionnaire (ABC-6)(From enrollment to end of 4 weeks and 8 weeks of treatment)
研究者
Maruti Gudavalli
Professor
Keiser University College of Chiropractic Medicine
研究点 (1)
标识符
- NCT 编号
- NCT06965920
- 其他研究编号
- IRB000NV23MG145
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (4个月前)
- 研究完成日期
- (4个月前)
- 最近核实
- 最近更新
- (去年)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
Will be shared as long as the receiving party signs confidentiality agreement
