Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery for Aging Adults With Chronic SCI: The BO2ST-II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in walking recovery, assessed by 10 meter walk test (10MWT)
研究概览
简要总结
The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury of different age groups.
详细描述
The goal of the study is to determine the optimal dosage for different age groups of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with transcutaneous spinal cord stimulation (tSTIM) to improve recovery of walking and strength after spinal cord injury. Preliminary studies have shown that combining AIH and tSTIM with walking training can enhance individuals walking training greater than just AIH or tSTIM. By using low oxygen as a pre-treatment to tSTIM during walking training, functional independence and quality of life may improve. Despite exciting preliminary results supporting the efficacy of AIH and tSTIM to enhance walking recovery after SCI, understanding factors that may enhance or undermine treatment responsiveness is warranted. Factors include establishing the role of age and sex dependency on appropriate dosing (number of sessions) AIH to provide the greatest plasticity-promoting effects on walking recovery for our aging population of persons living with SCI.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 否
入选标准
- •18 to 80 years of age
- •medically stable with medical clearance from study physician to participate
- •SCI at or below C1 and at or above L2 with at least some sensory or motor function preserved below the neurologic level
- •non-progressive etiology of spinal injury
- •American Spinal Injury Association (ASIA) scores of C-D at initial screen
- •ambulatory (able to complete the 10-meter walk test without support from another person)
- •chronic injury (define as > 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery
排除标准
- •severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation
- •< 24 on Mini-Mental Exam
- •severe recurrent autonomic dysreflexia
- •history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure > 150 mmHg)
- •pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)
- •botulinum toxin injections in lower extremity muscles within the prior three months
- •history of tendon or nerve transfer surgery in the lower extremity
- •untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study.
- •active implanted devices (e.g., intrathecal baclofen pump)
- •receiving concurrent electrical stimulation
- •motor threshold evoked by transcutaneous spinal stimulation >200 mA
结局指标
主要结局
Change in walking recovery, assessed by 10 meter walk test (10MWT)
时间窗: Through study completion, an average of 14 weeks
Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Change is the difference between the post-treatment assessment 2 and pre-treatment baseline.
Rate of change in walking recovery, assessed by 10 meter walk test (10MWT)
时间窗: Through study completion, an average of 14 weeks
Participants walk ten meters without assistance at their fastest, but safest speed with a minimum of 1-minute of rest between two trials. Average speed across the up to three 10MWT trials will be used for analysis. Rate of change is the number of treatment sessions required to achieve an increase in 10MWT speed of at least the minimal clinically important difference (0.06 m/s) as compared to pre-treatment baseline.
次要结局
- Change in walking recovery, assessed by 6 minute walk test (6MWT)(Through study completion, an average of 14 weeks)
- Change in walking recovery, assessed by timed up-and-go (TUG) test(Through study completion, an average of 14 weeks)
- Change in pain severity, assessed by the Numeric Pain Rating Scale (NPRS)(Through study completion, an average of 14 weeks)
- Change in cognitive function, assessed by the California Verbal Learning Test (CVLT)(Through treatment completion, an average of 6 weeks)
- Counts of hypertensive events(Through treatment completion, an average of 6 weeks)
- Counts of blood pressure measurements(Through treatment completion, an average of 6 weeks)
- Systemic hypertension incidence rate(Through treatment completion, an average of 6 weeks)
- Number of autonomic dysreflexia events(Through treatment completion, an average of 6 weeks)
- Total person-time for autonomic dysreflexia(Through treatment completion, an average of 6 weeks)
- Autonomic dysreflexia incidence rate(Through treatment completion, an average of 6 weeks)
- Change in lower extremity strength, assessed by American Spinal Injury Association Impairment Scale (AIS) lower extremity motor scores (LEMS)(Through study completion, an average of 14 weeks)
- Change in spasticity, assessed by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)(Through study completion, an average of 14 weeks)
- Change in bowel dysfunction, assessed by the Neurogenic Bowel Dysfunction Score (NBDS) v2.1(Through study completion, an average of 14 weeks)
- Change in bladder dysfunction, assessed by the Neurogenic Bladder Symptom Score (NBSS)(Through study completion, an average of 14 weeks)
- Change in walking ability and assistive device use, assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI).(Through study completion, an average of 14 weeks)
- Change in physical assistance needed, assessed by Walking Index for Spinal Cord Injury (WISCI) II(Through study completion, an average of 14 weeks)
- Change in breathing function, assessed by FVC(Through study completion, an average of 14 weeks)
- Change in apnea hypopnea index(Through treatment completion, an average of 6 weeks)
研究者
Randy Trumbower, PT, PhD
Principal Investigator
Spaulding Rehabilitation Hospital