Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Number and type of device-related Adverse Events
研究概览
简要总结
The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis.
The secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.
详细描述
This is a pre-post, single-centre, quasi-experimental study with an estimated duration of 16 weeks. The study will be conducted at therapy2people GmbH (Vienna, Austria). A minimum of 15 participants (5 per subgroup: spinal cord injury, acquired brain injury, multiple sclerosis) will be recruited within a period of up to 8 weeks.
After providing informed consent, participants will undergo a screening visit to confirm eligibility based on predefined inclusion and exclusion criteria. At the latest, one week after screening, participants will complete a baseline assessment.
The intervention will consist of 8 gait training sessions with the ABLE Exoskeleton with Functional Electrical Stimulation integration(ABLE FES), performed twice per week over 4-5 weeks. Each session will last approximately 60 minutes and include donning/doffing, walking training, and safety/performance assessments. Electrode placement and stimulation parameters will be adapted to the participant's neurological condition.
Outcome measures will focus on device safety (adverse events, serious adverse events, withdrawals) and clinical performance (donning/doffing time, walking distance, number of steps, standing time, therapist assistance, gait parameters, and motor torque). Additional measures will include lower limb spasticity, pain, perceived exertion, user satisfaction, and tolerance to FES.
For safety monitoring during sessions involving functional electrical stimulation (FES) with the exoskeleton, vital signs including heart rate and blood pressure will be measured before, during, and after the intervention sessions.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years old
- •Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis
- •Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center
- •Ability to provide informed consent
排除标准
- •Significant osteoporosis that may increase the risk of fracture
- •Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
- •Spinal instability (or use of spinal orthoses, unless medically approved)
- •Deterioration >3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
- •Severe spasticity: Level 4 on the Modified Ashworth Scale
- •Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position
- •Uncontrolled autonomic dysreflexia
- •Medical instability
- •Unstable cardiovascular condition, hemodynamic instability, untreated hypertension (SBP > 140 mmHg, DBP > 90 mmHg), deep vein thrombosis (DVT), or uncontrolled autonomic dysreflexia
- •Severe comorbidities, including any condition deemed inappropriate by the investigator for using the ABLE Exoskeleton or for completing the study
- •Pressure ulcers Grade I or higher (as defined by the European Pressure Ulcer Advisory Panel - EPUAP) in areas that will be in contact with the device
- •Anthropometric measurements incompatible with the ABLE Exoskeleton, specifically height outside the 1.5-1.9 m range or weight exceeding 100 kg
- •Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device
- •Range of motion restrictions preventing normal gait or sit-to-stand transitions, including: Ankle: ability to achieve at least neutral (0°) position; Knee: ability to extend to at least -10°; Hip: bilateral hip flexion of at least 100° and extension of at least 0°
- •Heterotopic ossification
- •Pregnant or breastfeeding women
- •Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures
- •Requires assisted ventilation.
- •Scoliosis >40-50º Cobb angle.
- •Presence of pacemakers, defibrillators, or other non-compatible electronic implants.
- •Open wounds, infections, or active irritation at the electrode placement sites.
- •Severe dermatological conditions in the stimulation area.
- •Uncontrolled active epilepsy.
- •Malignant tumors in the area of application.
- •Severe loss of sensation in the areas where electrodes are to be placed.
- •Medical conditions where electrical stimulation is contraindicated by physician recommendation.
- •Inability to communicate pain, discomfort, or adverse reactions during stimulation.
- •Venous thrombosis, thrombophlebitis, or severe arterial obstruction.
- •Chronic venous insufficiency with significant varicosities.
- •Hemophilia.
- •Ongoing infectious process or fever.
- •Presence of metallic implants in the flow area between the electrodes
研究组 & 干预措施
Gait training with ABLE Exoskeleton + Functional Electrical Stimulation (ABLE FES)
Participants will undergo 8 rehabilitation sessions over 4-5 weeks using the ABLE Exoskeleton with Functional Electrical Stimulation integration (ABLE FES). Each session will last approximately 60 minutes and include donning/doffing, gait training, and functional assessments. Electrode placement and stimulation parameters will be adapted to the participant's pathology (spinal cord injury, acquired brain injury, or multiple sclerosis). Participants will also complete baseline, post-training, and follow-up assessments.
干预措施: ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES) (Device)
结局指标
主要结局
Number and type of device-related Adverse Events
时间窗: From baseline to follow-up (up to 2 weeks after end of intervention)
To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE), and withdrawals related to the device will be recorded and classified by type and severity throughout the study period.
Time taken to don/doff the device
时间窗: Up to 5 weeks (8 sessions)
The time taken to don and doff the ABLE Exoskeleton with FES will be measured during each gait training session. Donning time will start from the moment the participant is ready to transfer into the device until all straps and clips are tightened. Doffing time will start from the moment the participant begins removing the device until it is fully removed. Time will be reported in minutes and seconds.
Number of steps walked
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the number of steps taken with the device (step count) will be automatically measured and recorded by the device.
Distance walked
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the distance walked with the device will be automatically measured and recorded by the device and reported in meters.
Time spent upright and time spent walking
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the time spent upright and the time spent walking with the device will be automatically measured and recorded by the device and reported in minutes.
Number of therapists assisting the session
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the number of therapists assisting the participant during the session will be recorded.
Assistive device used
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the assistive device used (walker, crutches, cane, second therapist, etc) will be recorded.
Step Length
时间窗: Up to 5 weeks (8 sessions)
Step length (in cm) will be automatically measured and recorded during each gait training session by the device.
Step Symmetry
时间窗: Up to 5 weeks (8 sessions)
Step symmetry (in %) will be automatically measured and recorded during each gait training session by the device.
Center of mass displacement (cm)
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the center of mass displacement (cm) will be automatically measured and registered by the device
Motor torque (Nm)
时间窗: Up to 5 weeks (8 sessions)
In each gait training session, the motor torque (Nm) will be automatically measured and registered by the device
次要结局
- FES tolerance(During each training session (up to 5 weeks, 8 sessions))
- Clinical observation(During each training session (up to 5 weeks, 8 sessions))
- Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score(Post-training (up to 6 weeks))
- Borg Rating of Perceived Exertion(From baseline to post-training (up to 6 weeks))
- Location and level of pain(From baseline to post-training (up to 6 weeks))
- Lower limb spasticity(At baseline and post-training (up to 6 weeks))
- Minimum tolerated assistance in Functional Test(At baseline, each training session (4-5 weeks) and post-training (up to 6 weeks))