Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Postural Balance
研究概览
简要总结
The overall purpose of the study is to investigate effect of Digitally Supported Home Exercises (DSHE) in different groups for which digitally supported interventions could be beneficial. Balance is altered in individuals with low back pain and requires intervention Thus, the investigators will focus on the effect of DSHE to improve postural balance.
详细描述
The investigators want to investigate whether a digitally supported exercise program can improve the balance of people with non-specific lower back pain. During the exercise program, a computer game at home is controlled with the help of sensors attached to the body. Second aim is to record the daily activities of the participants and compare them with the back pain.
The 120 participants in this study will be divided into four groups (A, B, C and D). In groups A and B 20 patients are included who are in treatment for chronic back pain and receive Medical Training Therapy (MTT). For groups C and D the investigators will invite each 40 participants who have back pain but are not in treatment for their back pain. Only participants in groups A and C receive the digitally supported home exercise program. Who gets the training program is randomized using stratified block randomization.
The balance of all participants is measured four times. Between the 2nd and 3rd measurement the digitally supported exercise program is carried out. Between the 3rd and 4th assessement, participants in group A and C can exercise as much as they wish. The person who carries out the balance tests will not be informed which participant is in which group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will be informed, instructed and provide consent to the study assistant, while assessments will be taken by a measurement assistant, blinded to the group assignment. Data which is not collected in all groups (e.g. intervention adherence) will be collected and managed by the study assistant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A and B
- •Patients with chronic unspecific low back pain
- •Patients of the Medical Training Therapy (MTT)
- •Adult male and female participant's (≥18 years)
- •Informed consent as documented by signature
- •Inclusion Criteria Group C and D
- •Participant reports unspecific low back pain
- •Receiving no therapy nor medical treatment for the last 6 months
- •Adult male and female participant's (≥18 years)
- •Informed consent as documented by signature
排除标准
- •Patients with specific causes for low back pain
- •Radicular syndrome
- •Unable to participate currently in the program due to pain
- •Pregnancy
- •Medication effecting postural balance
- •Uncorrected heavy visual impairment
- •Allergy to adhesive tape
- •Unable to understand and communicate in German or English
研究组 & 干预措施
Patients exercise
Low back pain patients Next to basic medical physical training therapy group A receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system.
干预措施: Digitally supported home exercises (Other)
Patients control
Low back pain patients Group B will receive basic medical physical training therapy
Non-patients exercise
non-patients Groups C will receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system.
干预措施: Digitally supported home exercises (Other)
Non-patients control
non-patients Group D will receive no intervention
结局指标
主要结局
Postural Balance
时间窗: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest2)
Change of postural sway in anterior- posterior direction. Larger sway indicates worse balance. During each visit, 4 assessment repetitions of each 120 seconds are performed.
次要结局
- Motor Control(At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2))
- Low back pain intensity(At balseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2))
- Disability(At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 ( posttest 2))
- Health quality of life(At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2))
- Fear of movement(At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2))
- Fear of specific movements(At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2))
- Self-efficacy for managing chronic diseases(At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2))