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临床试验/NCT05573932
NCT05573932进行中(未招募)不适用

The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home Exercise Packet in Individuals With Low Back Pain

University of Central Florida2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Change in Disability

研究概览

简要总结

Two groups with non-specific low back pain will be completing the same exercise protocol. The leaderboard group will have a gamified experience and the take-home packet group will be using a paper take-home packet. Outcomes will be measured at 3 weeks, 6 weeks, with pain and disability also being measured at 12 and 18 months.

详细描述

There will be two groups in this study, the leaderboard group, and the take-home packet group. The leaderboard group and the take-home packet group will be completing the same exercise program throughout the 6-weeks. The exercises included the plank, side plank (left and right side), foot elevated (left and right side), dead bug and bird dog exercise until discontinuation. The exercises will increase with repetitions every two weeks and that outline is listed below in procedures involved. The leaderboard group will have on demand video access to the exercises and the take-home packet group will have a take-home packet. The leaderboard group will also be receiving weekly leaderboards of average and top exercise durations of the leaderboard group participants. The audio description of exercise in the on-demand video group is the same script as the written description in the take-home packet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Participants will be randomized into the two separate groups using a random number generator and allocation will be concealed in opaque envelopes prior to data collection.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must be 18-45 years old
  • Biological sex of Male or Female
  • Self-reported low back pain within the previous 6 months or greater than 3 episodes within the past 3 years

排除标准

  • Must not be currently seeing and or receiving care from an athletic trainer, physical therapist, or other rehabilitation specialist in the previous 6 months
  • Must not have low back pain conditions such as lumbar spondylosis, herniated disc, spondylolisthesis, previous spine surgery, currently pregnant, experiencing neurological symptoms or other muscular abnormalities
  • Unable to assume the exercise starting position
  • Current use of lidocaine patches or prescription pain medicine

结局指标

主要结局

Change in Disability

时间窗: Change from baseline to 18 months

Assessed with the Oswestry Disability Index

Change in pain

时间窗: Change from baseline to 18 months

Assessed by the numeric pain rating scale

Adherence

时间窗: Change from baseline to 6 weeks

Assessed by the exercise adherence rating scale

Change in Muscle thickness of the lateral abdominal wall

时间窗: Change from baseline to 6 weeks

Assessed with ultrasound during static positions and exercise starting positions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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