Effects of End-effector Based Training vs. Conventional Gait Training With Incomplete Spinal Cord Injury. A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in walking ability
研究概览
简要总结
Background: In Switzerland, about 6000 individuals live with the consequences of a spinal cord injury (Brinkhof et al, 2016). One of the major goals after an incomplete spinal cord injury (iSCI) is to regain walking function. To this end, different approaches are used in rehabilitation such as treadmill-based, robotic-assisted (exoskeleton or end-effector) and conventional gait training. According to current literature, the superiority of one of these approaches remains unclear (Mehrholz, Harvey, Thomas, and Elsner, 2017); In the research on gait rehabilitation after iSCI, recent randomized clinical trials (RCTs) found no statistical differences between conventional gait training and robotic-assisted gait training. Nevertheless, according to the comparison of effect sizes obtained from these training, these trials suggested that the conventional training approach leads to larger improvements in gait capacity when compared to robotic-assisted therapy (Field-Fote and Roach, 2011; Nooijen, Ter Hoeve, and Field-Fote, 2009). Therefore, these trials highly recommended further research considering these aspects. However, in clinical settings, the implementation of such systematic and intense training sessions remains challenging. The present study aims to test the hypothesis that conventional training might have larger effect sizes on gait capacity and to evaluate the feasibility of such systematic training in a clinical setting of inpatient rehabilitation.
Objectives: To contribute to the current knowledge on best clinical practice in gait rehabilitation within the iSCI population. More specifically, the study objectives are two-fold: A first objective is to compare the effects of conventional training, end-effector based therapy and the combination of these interventions on the gait ability of iSCI. A second objective is the evaluation of the feasibility of systematic gait training protocols in a clinical setting.
Participants: Individuals with motor incomplete spinal cord injury (iSCI), presenting a traumatic or non-traumatic iSCI with an injury onset <6 months.
Intervention: Participants will be trained in one of the three groups by trained physical therapists during 10 sessions, 3x/week with an average duration of 30 minutes.
Outcomes: To attain the first objective the effects will be quantified by the following main outcomes: Walking capacity (independence), walking speed, and safety. Feasibility of the systematic intervention will be evaluated using the drop-outs of therapy interventions.
详细描述
Background and Rationale:
The present study aims to add evidence for best practice in gait recovery interventions for individuals with incomplete SCI (iSCI). In contrast to post-stroke rehabilitation, the evidence on best practice for gait recovery for individuals with iSCI is less well-founded. A recent Cochrane review and the guidelines from the Deutsche Gesellschaft für Neurorehabilitation suggests that in post-stroke rehabilitation the combination of conventional gait training (walking overground) and robotic-assisted gait training is most successful to improve gait capacity (Mehrholz et al., 2014; Dohle et al., S2e Leitlinie ReMoS, 2015); Furthermore, guidelines suggest according to the high level of evidence, that the use of robotic-assisted training is advantageous to improve walking speed and endurance in individuals with post-stroke.
Such recent guidelines for spinal cord injury do not yet exist to knowledge of the investigators. In 2014 a Cochrane Review was published indicating that there is insufficient evidence about the best practice for gait recovery in incomplete SCI individuals (Mehrholz, Pohl, Elsener, 2014). Recently, a systematic review points out the critical assumption that according to the present evidence robotic-assisted gait training is not superior to conventional gait training (walking overground) (Mehrholz et al, 2017).
Since these studies suggest a high frequency of training and systematic intervention over several weeks (ex.: 4-5x / week; over 3 weeks) the present investigators would like to conduct a randomized-controlled trial with a two-fold aim: 1. Adding evidence to existing knowledge on gait rehabilitation best practice in individuals with iSCI. And 2) assessing the feasibility of such a protocol in a clinical setting in daily clinical practice. The latter is a very important aspect considering that the transfer from research knowledge into clinical practice is a large challenge (Maher et al, 2004). Among the most frequent barriers to implement evidence into practice are methodological problems (66%), a lack of replication (54%) and poor generalisability (53%) according to the analysis by Metcalf and colleagues on 715 clinicians (physio-, occupational, speech and language therapists) (Metcalfe et al, 2001).
Study design:
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)
盲法说明
The assessors are blinded since the testing assessor is not conducting the randomization. Patients and the physiotherapists conducting the training are not blinded. This is not due to the training location.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incomplete paraplegia or quadriplegia and classification of C and D in the AIS Score from the American Spinal Injury Association (ASIA) (Kirshblum and Waring, 2014).
- •The participants should be able to get from a sitting position to a standing position with the aid of an assistant and bars
- •Participants need to have a stable cardiovascular condition, absence of known heart disease or a known heart disease classified as class I or II in the New York Heart Association Classification system (American College of Sports Medicine; Guidelines for exercise testing, 2014); medical history is verified by the medical doctor from the SCI ward the REHAB Basel.
- •Sufficient compliance for the treatment action
- •And have signed the informed consent for the present study
排除标准
- •The presence of any one of the following exclusion criteria will lead to exclusion of the participant
- •Patients with an ASIA classification of A and B
- •Patients who are unable to stand up from a chair with moderate or no personal assistance
- •Patients diagnosed a high-grade osteoporosis
- •Patients with severe lower limb movement restrictions (contractions or fractures)
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
研究组 & 干预措施
CT - Group
The conventional training consists of gait training during walking over ground. It includes the standard interventions therapists apply during training over ground. The aim is to achieve as many steps as possible. Three training sessions per week of intensive over ground therapy are planned, and twice a week a therapy with focus of attention isn't walking.
干预措施: Conventional gait training (Other)
EET - Group
In the end-effector-based training participants undergo gait training in the end-effector device lyra (THERA-trainer). The principle of an end-effector is that the movement is induced at the level of participants feet. Furthermore, participants wear a harness attached to the end-effector lyra for safety purpose and for weight support. Three training sessions per week of intensive over lyra therapy are planned, and twice a week a therapy with focus of attention isn't walking
干预措施: End-effector based gait training (Other)
CETcomb:
The group with the combined training receives 5 sessions of CT and EET each. The pattern of series per week is always either two sessions of CT with one session of EET or vice versa.
干预措施: combined training (conventional and end-effector-based) (Other)
结局指标
主要结局
Change in walking ability
时间窗: Conducted 2 or 3 days prior to the intervention (Pre-evaluation) and repeated 1-2 days after the last training session of a 2.5 -3 weeks of intervention time. Assessment duration about 2 Minutes.
The capacity to walk independently; This parameter is quantified using the functional ambulatory category (FAC); a 5-points scale (ordinal) to categorize the participant according to its independency in walking (Mehrholz et al, 2007)
Change in walking security
时间窗: Conducted 2 or 3 days prior to the intervention (Pre-evaluation) and repeated 1-2 days after the last training session of a 2.5 -3 weeks of intervention time. Assessment duration about 5-10 Minutes.
Walking security is quantified with the Timed Up and Go Test (Podsiadlo and Richardson, 1991). Therefore participants have to get up from a chair, walk three meters, turn around, walk back to the chair and sit down. The time required to conduct this task is measured. Participants are instructed to walk once at their comfortable speed and once as fast - but save - as possible.
Change in walking speed
时间窗: Conducted 2 or 3 days prior to the intervention (Pre-evaluation) and repeated 1-2 days after the last training session of a 2.5 -3 weeks of intervention time. Assessment duration about 5 Minutes.
Walking speed is quantified using the 10 meter walking test. Therefore the participants have to walk over a 10 meter walkway on level ground. Participants are instructed to walk once at their comfortable speed and once as fast - but save - as possible.
次要结局
- Feasibility of the training protocol(This outcome is analyzed at the end of the data collection and training sessions by the principal investigator at an estimated time of 15 months after trial start..)