Effect of Different Programs of Robotic Assisted Gait Training in Individuals With Chronic Motor Incomplete Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Baseline Gait speed
研究概览
简要总结
INTRODUCTION:
The ability to move and transfer own body in an effective manner, is frequently affected in people with a spinal cord injury with a negative impact in mood and quality of life, in such a way, that achieving an effective locomotion, is one of the main objectives in the rehabilitation program in a spinal cord injured patient.
There are different modalities of locomotion training in spinal cord injury, being the robotic orthosis among them, and offering until now, positive outcomes. However there´s still a lack of evidence of the optimal training characteristics, in order to establish the best time, number of sessions, and progression scheme. For these reasons, establishing the effects of different locomotion training programs will provide the necessary data in order to develop an effective training program for the maximum benefit of the patient.
OBJECTIVE To determine the effect of different training programs with robotic gait orthosis for patients with chronic motor incomplete spinal cord injury (SCI) (American Spinal Injury Association Impairment Scale (AIS) C / D) in short and long term.
METHODS AND DESIGN. The design of the study consists on a randomized, blinded to the observer, clinical trial.
Patients from the National Institute of Rehabilitation (INR) with spinal cord injury, AIS C and D, with at least 6 months of evolution, and who are able to walk with or without gait auxiliary, will be eligible.
Informed consent will be obtained from all subjects prior to participation. Patients will be randomly assigned to either one of the two different training groups: intervention or control group.
The control group will be submitted to training sessions of 30 minutes, and the intervention group will have training sessions of 60 minutes.
Both groups will receive a training period of six weeks, five days a week.
Throughout the training period, gait assessments with the GaitRite instrument, will be performed, and repeated at 6 and 12 months after completion of the training as part of follow up. The data obtained from the GaitRite will be compared within each group, in order to determine which type of training is more effective
Statistical analysis will be performed using SPSS, considering all P < 0.05 as statistically significant.
详细描述
A Spinal cord injury (SCI) is the disruption of the nerve pathways that connect the brain to the rest of the body, causing the cessation of their motor, sensory and vegetative functions. It is considered one of the most devastating clinical conditions affecting the functionality and independence of the individual.
The World Health Organization estimates an annual overall incidence of 40-80 new cases per million, equivalent to 250 000 to 500 000 individuals with spinal cord injury each year. The consequences of the SCI, significantly impair the ability of the patient to perform daily life activities, and their overall quality of life.Decreased mobility is the main element that affects lower satisfaction and quality of life. The improvement of mobility or the ability to move in an energy efficient manner improves the quality of life in patients with SCI.
The recovery of walking function is considered of great relevance both by patients and physicians. The most relevant prognostic factor for functional recovery in SCI patients is the neurological status at the moment of the first examination, considering the neurological level and the severity of the lesion according to the American Spinal Injury Association impairment scale (AIS).
According to Scivoletto, of the patients with American Spinal Injury Association (ASIA) impairment scale A, with thoracic and lumbar lesion only 6.4% achieve functional walking. In patients with ASIA B, have an overall rate of ambulation of 23.5%, ASIA C have 51.4% and ASIA D patients have a prognosis for walking recovery between 80-100% (88.9%).
In another study, Dobkin[8] reported that 35% of individuals classified as AIS B, 92% of subjects AIS C and all subjects AIS D recovered the ability to walk after gait training intervention with partial weight bearing for a period of 8 weeks. However, of all the patients with spinal cord injury, few regain a functional gait capacity, due to a low speed, a decreased step length, cadence and changes in rhythm and coordination.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incomplete SCI AIS C or D with at least 6 months of evolution.
- •Any etiology
- •Able to walk with or without walking aids.
- •Properly signed written informed consent.
排除标准
- •Orthopedic conditions like bone instability , arthrodesis
- •Metabolic pathology which impedes exercise.
- •Audio or visual alterations.
- •Own Robotic Orthoses (lokomat) counter-indications: body weight bigger than 135 kg, open lesions in skin of lower extremities or torso, non-cooperative patients, mechanical ventilation or continuum use of oxygen.
- •Uncontrolled pain.
结局指标
主要结局
Baseline Gait speed
时间窗: Before training
Analysed by the Gait Rite system (m/s)
Change in gait speed at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (m/s)
Change from baseline mean double support percentage at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-100%)
Change from baseline gait speed at one year
时间窗: At one year
Analysed by the Gait Rite system (m/s)
Change from baseline FAP at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-100)
Change in gait speed at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (m/s)
Change in gait speed at third training session
时间窗: Before and after the third session of training (day3)
Analysed by the Gait Rite system (m/s)
Change from baseline gait speed at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (m/s)
Change from baseline gait speed at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (m/s)
Change from baseline gait speed at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (m/s)
Change from baseline gait speed at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (m/s)
Change in mean double support percentage at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (0-100%)
Change in mean double support percentage at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-100%)
Change from baseline mean double support percentage at second week
时间窗: At the end of the secondt training week
Analysed by the Gait Rite system (0-100%)
Change from baseline mean double support percentage at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-100%)
Baseline Functional ambulation profile (FAP)
时间窗: Before training
Analysed by the Gait Rite system (0-100)
Change in FAP at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (0-100)
Change in FAP at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-100)
Change from baseline FAP at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-100)
Change from baseline Mean single support at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-100%)
Baseline mean double support percentage
时间窗: Before training
Analysed by the Gait Rite system (0-100%)
Change in mean double support percentage at third training session
时间窗: Before and after the second session of training (day 3)
Analysed by the Gait Rite system (0-100%)
Change from baseline mean double support percentage at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-100%)
Change from baseline mean double support percentage at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-100%)
Change from baseline gait speed at six months
时间窗: At 6 months
Analysed by the Gait Rite system (m/s)
Change from baseline mean double support percentage at one year
时间窗: At one year
Analysed by the Gait Rite system (0-100%)
Change in FAP at third training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-100)
Change from baseline FAP at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-100)
Change from baseline FAP at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-100)
Change from baseline FAP at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-100)
Change from baseline FAP at one year
时间窗: At one year
Analysed by the Gait Rite system (0-100)
Baseline Mean single support
时间窗: Before training
Analysed by Gait Rite System (0-100%)
Change in Mean single support at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (0-100%)
Change in Mean single support at second training session
时间窗: Before and after the first session of training (day 2)
Analysed by the Gait Rite system (0-100%)
Change in Mean single support at third training session
时间窗: Before and after the first session of training (day 3)
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean single support at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean single support at one year
时间窗: At one year
Analysed by the Gait Rite system (0-100%)
Change from baseline Step time at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-10s)
Change from baseline Step length at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-1m)
Change in Mean double support at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (0-100%)
Change in Mean double support at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean double support at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean double support at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-100%)
Change in Support base width at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-1m)
Change in Support base width at third training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-1m)
Change from baseline Mean single support at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean single support at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-100%)
Change in Step time at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (0-10s)
Change from baseline Mean single support at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-100%)
Baseline Step time
时间窗: Before training
Analysed by Gait Rite System (0-10s)
Change in Step time at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-10s)
Change in Step time at third training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-10s)
Change from baseline Step time at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-10s)
Change from baseline Step time at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-10s)
Change from baseline Step time at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-10s)
Change from baseline Step time at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-10s)
Change from baseline Step time at one year
时间窗: At one year
Analysed by the Gait Rite system (0-10s)
Baseline Step length
时间窗: Before training
Analysed by Gait Rite System (0-1m)
Change in Step length at first training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-1m)
Change in Step length at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-1m)
Change from baseline Step length at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Step length at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Step length at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Step length at one year
时间窗: At one year
Analysed by the Gait Rite system (0-1m)
Baseline Mean double support
时间窗: Before training
Analysed by Gait Rite System (0-100%)
Change from baseline Step length at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system(0-1m)
Change in Mean double support at third training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean double support at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean double support at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean double support at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-100%)
Change from baseline Mean double support at one year
时间窗: At one year
Analysed by the Gait Rite system (0-100%)
Change in Support base width at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system(0-1m)
Change from baseline Support base width at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-1m)
Baseline Support base width
时间窗: Before training
Analysed by Gait Rite System (0-1m)
Change from baseline Support base width at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Support base width at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Support base width at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-1m)
Change in Step width at first training session
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system(0-1m)
Change from baseline Step width at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Step width at one year
时间窗: At one year
Analysed by the Gait Rite system (0-1m)
Change from baseline Variation coefficient of the plantar support´s lenght at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Variation coefficient of the plantar support´s lenght at one year
时间窗: At one year
Analysed by the Gait Rite system (0-100%)
Change from baseline Variation coefficient of the plantar support´s lenght at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Support base width at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-1m)
Change from baseline Support base width at one year
时间窗: At one year
Analysed by the Gait Rite system (0-1m)
Change in Step width at third training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-1m)
Change from baseline Step width at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-1m)
Change from baseline Variation coefficient of the plantar support´s lenght at second week
时间窗: At the end of the second training week
Analysed by the Gait Rite system (0-100%)
Baseline Step width
时间窗: Before training
Analysed by Gait Rite System (0-1m)
Change in Step width at second training session
时间窗: Before and after the second session of training (day 2)
Analysed by the Gait Rite system (0-1m)
Change from baseline Step width at first week
时间窗: At the end of the first training week
Analysed by the Gait Rite system (0-1m)
Change from baseline Step width at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-1m)
Baseline Variation coefficient of the plantar support´s lenght
时间窗: Before training
Analysed by Gait Rite System (0-100%)
Change in Variation coefficient of the plantar support´s lenght at first training sesion
时间窗: Before and after the first session of training (day 1)
Analysed by the Gait Rite system (0-100%)
Change in Variation coefficient of the plantar support´s lenght at second training session
时间窗: Before and after the first session of training (day 2)
Analysed by the Gait Rite system (0-100%)
Change from baseline Step width at the end of the training
时间窗: At the end of the sixth training week
Analysed by the Gait Rite system (0-1m)
Change in Variation coefficient of the plantar support´s lenght at third training session
时间窗: Before and after the third session of training (day 3)
Analysed by the Gait Rite system (0-100%)
Change from baseline Variation coefficient of the plantar support´s lenght at fourth week
时间窗: At the end of the fourth training week
Analysed by the Gait Rite system (0-100%)
Change from baseline Variation coefficient of the plantar support´s lenght at six months
时间窗: At 6 months
Analysed by the Gait Rite system (0-100%)
次要结局
- Change from baseline Strength at six months(At 6 months)
- Change from baseline Spasticity at six months(At 6 months)
- Change from baseline Strength at the end of the training(At the end of the sixth training week)
- Baseline Strength(Before training)
- Baseline Spasticity(Before training)
- Baseline Range of motion (ROM)(Before training)
- Change from baseline SCIM-III at six months(At 6 months)
- Change from baseline Spasticity at one year(At one year)
- Change from baseline Satisfaction with life at one year(At one year)
- Change from baseline Strength at one year(At one year)
- Change from baseline Spasticity at the end of the training(At the end of the sixth training week)
- Change from baseline Range of motion (ROM) at six months(At 6 months)
- Change from baseline Range of motion (ROM) at the end of the training(At the end of the sixth training week)
- Change from baseline Range of motion (ROM) at one year(At one year)
- Baseline SCIM-III (Spinal Coprd Independence Measure III)(Before training)
- Change from baseline SCIM-III at the end of the training(At the end of the sixth training week)
- Change from baseline SCIM-III at one year(At one year)
- Baseline Satisfaction with life(Before training)
- Change from baseline Satisfaction with life at the end of the training(At the end of the sixth training week)
- Change from baseline Satisfaction with life at six months(At 6 months)
- Baseline Functioning, Disability and Health classification(Before training)
- Change from baseline Functioning, Disability and Health classification at six months(At 6 months)
- Change from baseline Functioning, Disability and Health classification at the end of the training(At the end of the sixth training week)
- Change from baseline Functioning, Disability and Health classification at one year(At one year)
研究者
Jimena Quinzaños
Chief of Neurologic Rehabilitation Department
Instituto Nacional de Rehabilitacion