Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients with Hemiparesis in the Acute/subacute Phase (Month 1 to 4)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Wandercraft
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton.
研究概览
简要总结
The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial.
This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group.
The duration of the intervention period in both groups is 6 weeks.
- For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.
- For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).
The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •First clinically significant disability due to stroke
- •Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
- •Functional Ambulation Category score (FAC) <2
- •Patient with health insurance
- •Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he/she can still be included if the signature can be done by an impartial witness.
排除标准
- •Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
- •Recent fracture (< 3 months) or any therapy inducing secondary osteoporosis
- •Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
- •Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
- •Medical contra-indication to medium intensity physical strain
- •Orthostatic hypotension (loss of > 20 mmHg systolic BP after 3 minutes in standing position)
- •Uncontrolled seizures
- •Morphological contra-indications to the use of Atalante (as per user's manual)
- •Pregnant woman
- •Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention
- •Concurrent participation in another interventional trial
结局指标
主要结局
Walking recovery expressed by the proportion of patients reaching a Functional Ambulation Category (FAC) score of 4 or higher at the end of the intervention period, assessed without the exoskeleton.
时间窗: End of the intervention period (week 6)
The FAC is a 6-item ordinal scale that classifies the level of support needed to walk safely, irrespective of the use of a lower extremity orthosis or walking aid, ranging from 0 (unable to walk without the assistance of two people) to 5 (independent walking on uneven surfaces and on stairs).
次要结局
- Walking recovery expressed by the proportion of patients reaching a FAC score of 4 or higher at six months post stroke, assessed without the exoskeleton.(6 months post stroke)
- Change in transfer time from wheelchair to toilet and back to wheelchair(Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days))
- Time to reach FAC score of 4 or higher(Day 1 (± 3 days), week 2 (± 3 days) and week 4 (± 3 days) after the beginning of the intervention period, end of the intervention period (Week 6 ± 3 days), discharge from hospital and 6 months post stroke (± 6 days).)
- Changes in perceived quality of life assessed by the Short Form-36 (SF-36)(Day 1 (± 3 days) and 6 months post stroke (± 6 days))
- Change in walking speed measured with the 10 Meter Walk Test (10MWT)(Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days))
- Changes in maximal clinical muscle extensibility XV1 and maximal range of active motion XA against the resistance of the key lower limb muscles using the Five Step Assessment(Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days))
- Perceived workload by the therapists conducting sessions assessed with the NASA Task Load Index(End of Week 1 (± 3 days) and end of the intervention period (Week 6 ± 3 days))
- Changes in static and dynamic balance measured by the Berg Balance Scale (BBS)(Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days))
- Subject and Therapist satisfaction and willingness to continue training sessions(End of Week 1 (± 3 days), end of Week 3 (± 3 days) and end of the intervention period (Week 6 ± 3 days))
- Changes in anxiety and depression scores using the Hospital and Depression scale (HAD)(Day 1 (± 3 days), end of the intervention period (Week 6 ± 3 days), discharge and 6 months post stroke (± 6 days))