Development of a Novel Evaluation Scale of Mental Body Representation (MBR) for Adults With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Reliability of the scale
研究概览
简要总结
The purpose of this study is twofold: (1) Develop a new evaluation scale for mental body representations (MBR, i.e., body awareness and visuospatial body maps) for adults with spinal cord injury (SCI) with and without neuropathic pain. (2) Assess the psychometric properties of usability, reliability, and validity of the new evaluation scale This is a cross-sectional observational study design. For Aim 1, this study will involve initial item generation for a novel MBR evaluation scale for SCI through email communication, and individual interviews proctored remotely through Zoom, or, if preferred by the participant, in-person. For Aim 2, the study will include a Zoom call for consenting and questionnaires, as well as an in-person visit where participants will be tested with the new SCI-BodyMap evaluation scale, and a questionnaire asking about the usability and satisfaction of the new evaluation scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Control group
- •Uninjured adults (from the contact list with the Brain Body Mind lab or through fliers or StudyFinder)
- •18+ years old adults
- •18+ years old, participants with an incomplete or complete SCI of ≥ 1 year
- •medically stable
- •able to read and understand English
- •having access to the internet/iPad/computer/phone and willing to come in for an in-person testing at the University of Minnesota.
排除标准
- •Uncontrolled seizure disorder;
- •cognitive impairment and/or communicative disability (e.g., due to brain injury) preventing them from following directions or from learning;
- •ventilator dependency;
- •major medical complications;
- •pressure ulcers hindering prolonged sitting or lying down.
结局指标
主要结局
Reliability of the scale
时间窗: 1 week
Inter-rater reliability of the new SCI-BodyMap scale (scores from two physical or occupational therapists testing the same participants) will be evaluated with Kappa and ICC.
Validity of the scale
时间窗: 1 week
Convergent validity of the newly developed SCI-BodyMap scale for SCI will be tested with Spearman rho correlations between the new MBR scale and the Revised Body awareness scale, Multidimensional Assessment lnteroceptive Awareness-2 (MAIA- 2), lowest, average and highest neuropathic pain levels with the Numeric Pain Rating Scale (NPRS), and the NINOS-COE SCI Functional lndex/Assistive Technology Scale (SCI/Fl-AT).
establish the minimal detectable difference (MDD)
时间窗: 1 week
The Minimal Detectable Difference (MOD) will be calculated using the standard error of measurement.
次要结局
- QQ-10 scale, to assess the usability of the new MBR scale.(1 week)
- SCI-related symptoms (Penn Spasm Frequency Scale(1 week)
- SCI-related symptoms (BARQ-R)(1 week)
- SCI-related symptoms (MAIA-2)(1 week)
- Physical functioning.(1 week)