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临床试验/NCT05471557
NCT05471557已完成不适用

Effects of Acute Pain on Motor Learning in Young vs Older Adults

University of Delaware2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2024年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Digit Span Forward Test

研究概览

简要总结

To date, the effects of pain on motor learning have not been thoroughly investigated, particularly in older adults. Broadly, the purpose of this research is to investigate the impact of acute pain on locomotor learning and its retention in older adults. The investigators hypothesize that acute pain impairs retention of locomotor learning in young and older adults and that in older adults, these deficits are worsened and are related to the degree of normal age-related cognitive decline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

Application of pain or no stimulus cannot be masked from participants, nor from outcomes assessors.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-35 (YA group only) or 55-85 (OA group only) years old
  • Sex-matched to a participant in the OA group (YA group only)
  • Self-identifying as generally medically healthy
  • Able to read, write and speak English
  • Able to provide informed consent and attend all testing sessions
  • Willing to undergo the experimental pain or non-painful electrical stimulation, if selected

排除标准

  • Resting HR < 50 or > 100 bpm
  • Resting BP < 90/60 or > 140/95 mmHg (YA group only) or > 165/95 (OA group only)
  • Any history or current mental health condition, learning/developmental disability or cognitive impairment, including severe untreated ADD/ADHD, severe untreated anxiety, severe untreated depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
  • Score on the MoCA <23
  • Score on the GAD-7 ≥ 10
  • Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
  • Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis that (for OA group only) affects activities of daily living or would confound testing or place the subject at risk by participating, such as a significant cardiovascular condition or event (e.g., heart attack < 3 months ago, uncontrolled atrial fibrillation, uncontrolled angina, or congestive heart failure, chronic obstructive pulmonary disorder, peripheral vascular disease)
  • Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
  • History of serious concussion or head injury, defined as a loss of consciousness for > 5 minutes and/or requiring medical treatment, or > 2 concussions over the lifespan
  • Any history of acute or chronic problems with balance, any dizziness, or > 1 fall in the last 12 months
  • Taking 4 or more medications (YA group only)
  • Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.)
  • Any current or chronic pain condition during the last year, located anywhere in the body with a (OA group only) pain intensity of > 2/10
  • Allergy to capsaicin or hot peppers
  • Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
  • Skin sensitivity to soaps/creams/perfumes or to heat
  • Poor circulation in the area targeted for the painful stimulus
  • Prior participation in a locomotor learning study in this lab within the last 2 years or prior participation in a study in this lab that included the cognitive testing battery within the last 2 years.

结局指标

主要结局

Digit Span Forward Test

时间窗: the change between baseline and during application of intervention

number of digits (numbers) that can be repeated back in the same order as they were presented

Motor Retention Magnitude

时间窗: 24 hours post learning (day 2)

degree to which the learned locomotor pattern has been remembered (in step length % change, normalized to the amount learned from day 1)

Motor Learning Magnitude

时间窗: immediately after learning (day 1)

degree to which the new locomotor pattern has been acquired (in step length % change)

Digit Span Backward Test

时间窗: the change between baseline and during application of intervention

number of digits (numbers) that can be repeated back in the reverse order from which they were presented

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susanne M Morton

Associate Professor

University of Delaware

研究点 (2)

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