CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 15
- 主要终点
- Improvement on the MCS in All Randomized Participants
研究概览
简要总结
Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.
详细描述
Administrative hold due to COVID-19 pandemic.
Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with overground ambulation.
Research Questions (Objectives) Will Veterans with chronic SCI of six months duration, who are medically stable and who use a wheelchair as SOC plus an exoskeletal-assisted walking (EAW) device in their home and community environments have clinically meaningful net improvements in mental health, bladder, bowel, and pain patient-reported outcomes compared with those who use only the SOC? Additionally, will the use of an EAW device for four months in the homes and/or communities of the participants result in a reduction of total body fat mass? Study Design A two-group (Intervention and Control), randomized, clinical trial will be performed with a one-year feasibility component. The Intervention group will receive SOC plus EAW. The Control group will receive SOC only. The study will require seven years in total to complete and includes fifteen VA SCI Services as study sites. A feasibility phase will be employed using a staggered start by initially starting six sites, four sites starting one year later, and 5 other sites starting two years later. These initial six sites will be used to assess the start-up activities [hiring, training, equipment procurement, Central Institutional Review Board (CIRB) paperwork, etc.], the rate of recruitment, and any other issues that may be of value for the successful completion of the study. Lessons learned will be implemented for the remaining sites.
Relevance to VA In pilot studies conducted at the James J. Peters VA Medical Center, Bronx, NY, improvements in mental-emotional health, physical health and body composition were demonstrated by providing the participants the ability to walk for 4 to 6 hours per week over the course of three to five months. As of July 2014, a Class 2 designation was established by the Food and Drug Administration (FDA) for "powered exoskeletons". To date, one device (ReWalk ) has received FDA Class 2 approval for institutional and home use and is currently available by prescription. The Department of Veterans Affairs (DVA) is the largest single provider to persons with SCI in the USA, caring for about 26,000 of the 42,000 estimated Veterans with SCI. The VA presently lacks the infrastructure to support Veterans with SCI to train to use this device in order to make this technology available for the home/community use. A controlled research study would be anticipated to be the optimal manner to demonstrate the efficacy, amount of use and safety of a powered exoskeleton in the home and community environments; findings would be immediately transferable to clinical care.
Number of Research Participants (Sample Size) One hundred-sixty participants (80/group) will be randomized. Each of the 15 study sites will be expected to pre-screen 100 potential participants, screen 60 participants, to reach the target of 160 randomized over 15 sites.
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
- 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
- •Veterans or active duty military personnel who are at least 18 years of age;
- •Traumatic or non-traumatic SCI 6 months duration of SCI;
- •Wheelchair-user for indoor and outdoor mobility;
- •Anthropometric compatibility with the device:
- •Weight <220 lb. (100 kg),
- •Thigh length between 14 and 19 in (36 and 48 cm),
- •Shank length between 17 and 22 in (43 and 55 cm);
- •Able to hold the crutches in hands without modifications;
- •Able to have a companion who can attend approximately one-third of the training sessions who will assist them at home and in the community; and
- •Able to provide informed consent.
排除标准
- •Diagnosis of neurological injury other than SCI;
- •Progressive condition that would be expected to result in changing neurological status;
- •Severe concurrent medical disease, illness or condition judged to be contraindicated by the Site Physician;
- •Unhealed or unstable traumatic or high impact lower extremity fracture (definition below) of any duration that is in the clinical judgement of the study physician to be exclusionary for standing and walking;
- •Knee BMD < 0.60 gm/cm2;
- •Total hip BMD T-scores < -3.5;
- •Fragility, minimal trauma or low impact fracture of the lower extremity since spinal cord injury (definition below);
- •Untreatable severe spasticity judged to be contraindicated by the Site Physician;
- •Flexion contracture > 15 degrees at the hip and/or > 10 degrees at the knee;
- •Limitations in ankle range of motion that cannot be adapted with an orthotic device (plantar flexion > 00);
- •Untreated or uncontrolled hypertension (systolic blood pressure >140 mmHg; diastolic blood pressure >90 mmHg);
- •Unresolved orthostatic hypotension (systolic blood pressure <90 mmHg; diastolic blood pressure <60 mmHg) as judged to be contraindicated by the Site Physician;
- •Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities;
- •Psychopathology documentation in the medical record or history that may conflict with study objectives; and/or
- •Pregnancy or women who plan to become pregnant during the study period.
研究组 & 干预措施
Exoskeleton + Standard of Care (SOC)
Patient will receive exoskeletal-assisted walking device for in home use for 4 months
干预措施: ReWalk 6.0 (Device)
Standard of Care (SOC)
Patient will receive standard of care (wheelchair use)
结局指标
主要结局
Improvement on the MCS in All Randomized Participants
时间窗: Change from Baseline Assessment to 4 Months Post Intervention
Number of randomized participants with a greater than or equal to 4 point change on the Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36) from Baseline Assessment to 4 Months Post Intervention. Possible range of the MCS is 0 to 100, with a higher score indicating higher mental wellbeing.
Improvement on the SCI-QOL Physical Medical Health Domain in All Randomized Participants
时间窗: Change from Baseline Assessment to 4 Months Post Intervention
Number of randomized participants with a greater than or equal to 10 percent decrease on the SCI-QOL Physical Medical Health Domain (PMH) from Baseline Assessment to 4 Months Post Intervention. The PMH score is a sum of the SCI-QOL scores from the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks. Possible range of the PMH score is 110 to 253, with a lower score indicating better physical medical wellbeing.
次要结局
- Total Body Fat Loss in All Randomized Participants(4 months post intervention)
- Improvement on the Mental Health Component Summary (MCS) in Participants Who Completed the 4 Month Intervention Phase.(4 months post intervention)
- Improvement on the SCI-QOL Physical Medical Health Domain in Participants Who Completed the 4 Month Intervention Phase.(4 months post intervention)
- Total Body Fat Loss in Participants Who Completed the 4 Month Intervention Phase.(4 months post intervention)
- Change in Mental Health Component Summary (MCS)(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in SCI-QOL Physical Medical Health Domain(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Total Body Fat(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in SCI-QOL Social Participation Domain(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in SCI-QOL Positive Emotional Constraints(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in SCI-QOL Negative Emotional Constraints(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in SCI Functional Index (FI)(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Sleep Disturbance(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Participant Impression of Severity(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Companion Impression of Severity(post training/orientation, two months post intervention, and 4 months post intervention.)
- Bowel Evacuation Time(4 months post intervention)
- Frequency of Bowel Evacuation Episodes(4 months post intervention)
- Manual/Digit Stimulation for Bowel Movements(4 months post intervention)
- Oral Medications for Bowel Movements(4 months post intervention)
- Enemas or Irrigations for Bowel Movements(4 months post intervention)
- Bowel Control(4 months post intervention)
- Stool Consistency(4 months post intervention)
- Change in Abdominal Fat Mass(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in High Density Lipoprotein Cholesterol(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Low Density Lipoprotein Cholesterol(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Total Cholesterol(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Triglycerides(post training/orientation, two months post intervention, and 4 months post intervention.)
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(post training/orientation, two months post intervention, and 4 months post intervention.)