Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
研究概览
简要总结
The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.
详细描述
Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.
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 (Care Provider)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
- •19 to 65 years of age
- •use of standing or walking as part of typical activities of daily living
- •controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study
排除标准
- •lesion below 11th thoracic level (lower motoneuron injury)
- •weight greater than 300 lbs or height greater than 6'1"
- •femur length <35 cm or >47 cm and body weight >150 kg
- •cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
- •existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness
- •existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
- •participation in rehabilitation therapy or other research study with exercise or mobility outcomes
结局指标
主要结局
The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
时间窗: 6 months
次要结局
- Average activity level per day measured before, after, 1-month after, and 6-months after training(6 months)