Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in kinematics
研究概览
简要总结
Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. The specific assessments will require the participant to acitvely modulate their gait pattern to fullfill specific task constraints. Their performance will be assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the adaptive capacity that the patient retains. Sensitivity and specificity of these markers will be determined. With more sensitive descriptors of gait function and quality, locomotor rehabilitation for SCI can be better designed and smaller effects can be accurately measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Healthy controls
- •Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
- •Age: 18 years and older
- •Able to stand without physical assistance and handrails for more than 120s
- •preserved segmental and cutaneo-muscular reflexes in the lower limbs
- •Bodyweight over 20 kg and under 120 kg
- •Mini-Mental state examination score 26 (test only performed if cognitive deficits are suspected)
排除标准
- •Current orthopedic problems
- •Neurological impairment other than SCI
- •Premorbid major depression or psychosis
- •Metal implants in the cervical skull
- •History of significant autonomic dysreflexia with treatment
- •Dermatological issues (e.g. decubitus) at the harness attachment site (back, abdomen, upper legs)
- •Malignant diseases
- •Heart insufficiency NYHA III-IV
- •Potential pregnancy
- •Unlikely to complete the intervention or return for follow-up
- •Participation in another training study
- •Contraindications for training using the GRAIL (according the manual)
结局指标
主要结局
Change in kinematics
时间窗: Baseline and through study completion, an average of 4 months
Recording of movement tasks
次要结局
未报告次要终点