Intensive Gait-assisted Versus Intensive Step-assisted Training After Acquired Brain Injury - a Randomised Cross-over Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Inclusion Rate
研究概览
简要总结
The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after acquired brain injury and disorders of consciousness. The main questions it aims to answer are:
- Is the protocol feasible concerning inclusion in the study?
- Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.
The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail.
详细描述
This is a randomised cross-over feasibility trial, carried out according to the Helsinki Declaration and approved by the scientific ethics committee of the Capital Region, Denmark. Participants are temporarily unable to consent why this obtained from the next of kin.
Participants start the intervention when 10 minutes of standing in a tilt-table does not cause orthostatic hypotension. Participants then recieve five days of intervention, two days pause and then cross over to the other intervention.
Groups:
- GAIT --> STEP
- STEP --> GAIT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None (Outcomes Assessor)
盲法说明
Assessors are blinded to allocation for the following exploratory clinical outcome scales: "Disability Rating Scale" and "Coma Recovery Scale-Revised".
Data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results.
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
- •Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Bodil Eskesen Centre, Rigshospitalet
- •Patients 18 years or older
- •In the unresponsive wakefulness or minimally conscious state after a moderate to severe acquired brain injury (ICD 10: S06, Intracranial injury; I60-I69, Cerebrovascular diseases).
- •Revised 11 November 2024: In the unresponsive wakefulness state, minimally conscious state or in the confusional state after a moderate to severe acquired brain injury (ICD 10: S06, Intracranial injury; I60-I69, Cerebrovascular diseases).
- •Obtained consent from nearest relative and study guardian.
排除标准
- •Weight > 135 kg (maximum weight for the Erigo® tilt table)
- •Height > 200 cm (maximum height for the Lokomat®)
- •In the confusional state or emerged to full consciousness Revised 11 November 2024: Emerged to full consciousness
- •If weight bearing is restricted due to, e.g., fractures of the spine, pelvis, or lower limbs.
- •Known osteoporosis of a severity where use of robotic orthoses, according to a physician, is considered a contraindication
- •If lower limb joints are fixated to a degree that cannot be compensated in the orthoses
- •No valid consent from the nearest relative or study guardian
研究组 & 干预措施
GAIT-assisted training
Gait-assisted training in the Lokomat Pro, (Hocoma, Switzerland) for five consecutive days. The Lokomat Pro is a fully automated robotic training device consisting of a treadmill, a body weight support system, two motor-driven leg orthoses, a screen for augmented feedback and a therapist-controlled computer.
The orthoses drive the swing phase of the gait, and their guidance force is adjusted between 10-100%. The body weight support can be adjusted between 10-100% of the body weight. The maximum walking speed is 3 km/h, and the cadence of the orthoses is calibrated to the treadmill.
The Lokomat has five different emergency and safety stops. Every 5 minutes, an automatic signal reminds the therapist to check in; if not, the Lokomat will automatically stop. Only therapist that has gone through specific education can operate the Lokomat.
干预措施: GAIT-assisted training (Other)
STEP-assisted training
Step-assisted training in the Erigo Pro, (Hocoma, Switzerland) for five consecutive days.
The computer-controlled tilt table consists of a verticalization table up to 90° and a choice of cyclic leg movements in three distinct patterns, between 8-80 steps/minute adjustable between 0-100% guidance force. The tilt table can be used with functional electric stimulation (FES). Weight-bearing of the legs is possible between 0-50 kg.
The Erigo has one safety stop and an emergency release handle in case of a power failure during operation. Only therapist that has gone through specific introduction can operate the Erigo.
干预措施: STEP-assisted training (Other)
结局指标
主要结局
Inclusion Rate
时间窗: 26 days from intervention start
To be deemed feasible, the inclusion rate must be 70% (12 out of 17 eligible patients), with a 95% confidence interval (CI) from 46.9% to 86.7%. The data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results.
Completion Ratio of protocols
时间窗: 26 days from intervention start
To be deemed feasible, the ratio of completed sessions must be 80% (68 out of 85 sessions per group) with a 95% CI from 70.3% to 87.1%. The data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results.
次要结局
- Exploratory Safety Outcomes(26 days from intervention start)
研究者
Christina Kruuse
Professor, Dr Med
Rigshospitalet, Denmark