Implementation of Locomotor Training Program Using a Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice for Persons With an Incomplete Spinal Cord Injury - WHY and HOW to do it?
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Modified Six Minute Walk Test (6MWT)
研究概览
简要总结
After partial spinal cord injury, gait deficits may be present and often remain even after intensive rehabilitation. New robotic technologies have recently emerged to help augment the extent of rehabilitation. However, these are complex tools to integrate into clinical practice and little is known about the potential factors that may influence the uptake of a locomotor program using this technology by clinicians. The goal of this project is to bring together researchers, administrators, clinicians and patients to define and implement an overground robotized gait training program in clinic. We will also investigate the added value of leg and trunk muscle stimulation combined with robotic walking training, to see if it could enhance recovery.
详细描述
Powered exoskeleton technology represents a promising rehabilitation intervention for persons with incomplete spinal cord injury (iSCI). The overall aim of the present study is to investigate the implementability of an overground locomotor training program using a powered exoskeleton in persons with a subacute iSCI at the Institut de réadaptation en déficience physique de Québec, with and without functional electrical stimulation (FES). Over the 2-year period of the project, a logic model will be co-developed with stakeholders to support clinicians and administrators in the management of the locomotor training program. Using qualitative and quantitative research methods, we will evaluate the feasibility and perceived barriers/facilitators to the implementation in clinical practice of the training program. Finally, a pre-post design with individuals receiving the intervention either combined with FES or not, will allow quantifying of the benefits of combining FES in addition to robotic gait training on functional walking capacity in persons with a subacute iSCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measure between 5'1" and 6'3" (1.5 and 1.9m)
- •Weigh less than 200 pounds (90kg)
- •Present a diagnosis of incomplete spinal cord injury
- •Have the ability to maintain a standing position and/or have therapeutic walking ability at Stage 1B or more of the Rick Hansen Institute SCI Standing and Walking Assessment Toolkit
- •Present sufficient upper extremity strength and function to use a walker with wheels
- •Femur length between 37 and 49cm
- •Width of hips when seated <42 cm
- •Obtain approval from a physician to participate in the project
- •Standing tolerance >15 minutes
- •Respond favourably to functional electrical stimulation (FES) of the main lower extremity muscle groups: (gluteus, quadriceps, hamstrings, dorsiflexors, etc.) as determined by a physiotherapist.
- •Have no contraindications to FES according to the guidelines of the Canadian physiotherapy association (CPA).
排除标准
- •Poor fit of the exoskeleton as determined by the research team
- •Present contraindications to the use of the Indego® exoskeleton as described by the company
- •Present lower extremity skin lesions or sores
- •Any medical condition or co-morbidity that may impair collaboration and participation or making it unsafe to wear the exoskeleton, for example (non-exhaustive list) :
- •Disabling pain.
- •Significant sensory disturbances in the lower limbs that limit safe walking.
- •Cognitive disorders that impair the ability to collaborate.
- •Osteoporosis.
- •Unconsolidated fractures of the lower limbs.
- •Uncontrolled reflex dysautonomia.
- •Severe peripheral vascular disease.
- •Severe heart failure.
- •Severe, active infection
- •FES Exclusion Criteria
- •Pregnancy;
- •Presence of a malignant tumor
- •Deep vein thrombosis
- •Hemorrhagic condition
- •Infection or osteomyelitis
- •Presence of weakened/damaged skin
- •Circulatory disorders
- •Electronic implant
结局指标
主要结局
Change in Modified Six Minute Walk Test (6MWT)
时间窗: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
A walking endurance test that measures the longest distance covered continuously during a maximum of six minutes.
Change in 10 meter Walk Test (10mWT)
时间窗: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Measures preferred and maximal walking speeds over 10 meters
Change in Modified Timed Up and Go test (TUG)
时间窗: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
A functional test that assesses sit-to-stand transfers, balance and mobility
Change in Walking Index for Spinal Cord Injury (WISCI-II)
时间窗: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
functional walking capacity scale that describes the amount of physical assistance, braces or devices required to walk 10 meters
次要结局
- Change in Brief pain inventory questionnaire(2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later))
- Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system.(2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later))
- Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS)(2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later))
- Change in the Modified Ashworth Scale (MAS)(2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later))
研究者
François Routhier
Full Professor/ Researcher
Laval University