Exploring the Effects of Rhythmic Auditory Stimulation on Gait in Motor Incomplete Spinal Cord Injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 10-Meter Walk Test (10MWT)
研究概览
简要总结
This pilot study aims to evaluate the feasibility and preliminary efficacy of a wearable rhythmic auditory stimulation system, MedRhythms, for improving gait parameters in patients with motor incomplete SCI. Up to 15 participants aged 18 years or older with non-progressive SCI will be enrolled. Participants will complete supervised gait training using the MedRhythms device twice weekly during regularly scheduled physical therapy sessions over a six-week period. The device uses shoe-mounted sensors and headphones to deliver real-time individualized rhythmic auditory cues based on the user's gait pattern.
Primary outcome measures include change in walking speed assessed with the 10-Meter Walk Test. Secondary outcomes include walking endurance measured by the 6-Minute Walk Test, gait parameters obtained through GAITRite analysis, and participant-reported outcomes including the Walking Index for Spinal Cord Injury II (WISCI II) and the SCI Quality of Life Satisfaction with Social Roles and Activities measure. Outcomes will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks).
Findings from this study will provide preliminary data on the feasibility and potential clinical impact of rhythmic auditory stimulation as an adjunctive gait rehabilitation strategy for individuals with incomplete SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Language: English or Spanish only
- •Diagnosis: non-progressive spinal cord lesion; classification as either grade C, D, or E SCI based on American Spinal Injury Association (ASIA) Impairment Scale (AIS)
- •Able to ambulate at least a contact guard assist level
- •Time post injury: ≥6 months
- •Cadence: minimum 40 steps/minute with clear heel strike
- •Able to consent
排除标准
- •Individuals who use an assistive device and are unable to achieve a 2-point walking pattern (left-right-left-right) with an assistive device
- •Walks exclusively with a 3-point walking pattern with an assistive device
- •Ambulation requiring a knee-ankle-foot orthosis (KAFO)
- •Presence of additional neurological or medical processes that contribute to weakness
- •Unable to perceive music through the MedRhythyms device
结局指标
主要结局
10-Meter Walk Test (10MWT)
时间窗: Baseline, post-intervention at 6 weeks and follow-up at 12 weeks
Measure of speed
次要结局
- 6-Minute Walk Test (6MWT)(baseline, post-intervention at 6 weeks, and follow-up at 12 weeks)