High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury Rehabilitation: An Effectiveness-implementation Hybrid Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Ten Metre Walk Test
研究概览
简要总结
People with incomplete spinal cord injury (SCI) often have some preserved movement and may regain walking ability, but recovery can be limited, and more effective rehabilitation approaches are needed.The goal of this clinical trial is to learn if high-intensity walking rehabilitation can improve walking recovery and overall neurological recovery in individuals with subacute SCI. The investigators are also exploring the process of incorporating this type of physical therapy approach in an outpatient rehabilitation setting.
The main questions it aims to answer are:
- Does high-intensity walking rehabilitation improve walking ability, compared to usual care for individuals with subacute spinal cord injury?
- What are some of the barriers and facilitators to delivering high-intensity walking rehabilitation in an outpatient setting?
The investigators will compare usual care rehabilitation to a high-intensity rehabilitation program to see if higher-intensity physical therapy leads to better walking outcomes and improved recovery. The study will also explore how feasible it is to deliver this type of program in a real-world outpatient rehabilitation setting and gather perspectives from both participants and clinicians.
Participants will:
- Attend regular outpatient physical therapy sessions focused on walking rehabilitation
- Receive either usual care or a higher-intensity walking program delivered by their physical therapist
- Have their activities, heart rate, step counts, and self-reported effort during therapy sessions monitored
- Complete walking, balance, and neurophysiological assessments at the start and end of rehabilitation
- Wear an activity monitor for one week at the beginning and end of the study to measure daily activity outside of therapy
- Participants who receive the higher-intensity intervention may participate in an interview to share their experiences with rehabilitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Adult (≥ 18 years of age)
- •Sustained a SCI within the past year
- •Motor incomplete SCI - classified as American Spinal Injury Association (ASIA) Impairment Scale levels C or D
- •Able to stand and initiate reciprocal steps through voluntary lower extremity movement but may require maximal physical assistance of at least one person and may include assistive devices (SWAT level 2A or above)
- •Indicate a walking-related goal on admission to outpatient physical therapy
排除标准
- •Medical or movement restriction(s) that limit high-intensity standing or walking rehabilitation (e.g., weight bearing restriction to lower extremities, cardiovascular constraints)
- •Inability to understand or communicate verbally in English
研究组 & 干预措施
High-intensity Rehabilitation
Participants will receive high-intensity physical therapy intervention
干预措施: High-intensity Rehabilitation (Behavioral)
Usual Care
Participants will receive usual physical therapy intervention
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change from Baseline in the Ten Metre Walk Test
时间窗: Baseline and end of rehabilitation (up to 12 weeks following baseline)
Time to walk ten metres; lower times indicate faster walking speed
次要结局
- Change from Baseline in the Six Minute Walk Test with Physiological Cost Index(Baseline and end of rehabilitation (up to 12 weeks following baseline))
- Change from Baseline in the Timed Up and Go(Baseline and end of rehabilitation (up to 12 weeks following baseline))
- Change from Baseline in the Modified Spinal Cord Injury Functional Ambulation Profile (mSCI-FAP)(Baseline and end of rehabilitation (up to 12 weeks following baseline))
- Change from Baseline in Motor-Evoked Potentials (MEPs)(Baseline and end of rehabilitation (up to 12 weeks following baseline))