Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Level of Assistance (LoA) to complete therapy activity tasks
研究概览
简要总结
The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed.
详细描述
This is a pre-post, single-center, quasi-experimental study with an estimated duration of 4 months since the approval date. The study will be conducted at the Fundación Esclerosis Múltiple de Madrid (FEMM), where a minimum of 20 participants are expected to be recruited over a maximum period of 2 months since the approval date.
After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a preliminary assessment without the medical device.
Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 11 weeks. Sessions will be conducted 1 to 2 times per week, depending on the participant's availability. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.
This is the first study investigating the use of the ABLE Exoskeleton in people with MS, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe and has adequate performance for the intended MS population in a clinical setting. The secondary hypothesis is that the device will have a positive impact on the muscular strength, spasticity, perceived rate of exertion, mobility, satisfaction, and quality of life of the study participants.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age.
- •Diagnosed with MS.
- •Currently receiving treatment as an inpatient or outpatient at one of the investigational site.
- •Ability to give informed consent.
排除标准
- •Significant osteoporosis that may increase the risk of fracture.
- •Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years.
- •Spinal instability (or spinal orthoses, unless authorized by a physician).
- •Severe spasticity: Level 4 on the Modified Ashworth Scale.
- •Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes of standing.
- •Uncontrolled autonomic dysreflexia.
- •Medically unstable
- •Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP>140, DBP>90 mmHg), unresolved deep venous thrombosis (DVT).
- •Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study.
- •Skin integrity problems on the contact surfaces of the device or that would prevent sitting.
- •Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton.
- •Colostomy.
- •Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg.
- •Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device.
- •Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting.
- •Heterotopic ossification
- •Known pregnancy or breastfeeding
- •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.
结局指标
主要结局
Level of Assistance (LoA) to complete therapy activity tasks
时间窗: Up to 11 weeks
Four therapy activity tasks will be attempted every session by the participant. The therapist will record the level of assistance required to complete each task during the session, using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. The tasks are the following: sit-to-stand, walk 10 meters, turn 180 degrees, and stand-to-sit.
Number of steps walked
时间窗: Up to 11 weeks
In each session, the number of steps taken (step count) with the device will be automatically measured and registered by the device.
Number and type of device-related Adverse Events
时间窗: Up to 16 weeks
To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.
Level of Assistance (LoA) to don/doff the device
时间窗: Up to 11 weeks
Level of Assistance (LoA) to don/doff the device will be measured in every session. The level of assistance will be measured using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. Different assistance levels are defined taking into account the degree of participation of both the participant and the therapist on performing the activity.
Time taken to don/doff the device
时间窗: Up to 11 weeks
The time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.
Time spent upright and time spent walking
时间窗: Up to 11 weeks
In each training session, the time spent upright (in minutes) and the time spent walking (in minutes) with the device will be automatically measured and registered by the device.
Distance walked
时间窗: Up to 11 weeks
In each session, the distance walked (in meters) with the device will be automatically measured and registered by the device.
次要结局
- Ambulation Index (AI)(Up to 11 weeks)
- Modified Ashworth Scale (MAS)(Up to 11 weeks)
- Trunk Impairment Scale (TIS)(Up to 11 weeks)
- Timed 25-Feet Walk test (T25FW)(Up to 11 weeks)
- Borg Rating of Perceived Exertion(Up to 11 weeks)
- Modified Fatigue Impact Scale (MFIS) score(Up to 11 weeks)
- Psychosocial Impact of Assistive Devices Scale (PIADS) score(Up to 11 weeks)
- 6-Minute Walk Test (6MWT)(Up to 11 weeks)
- Timed Up-and-Go test (TUG)(Up to 11 weeks)
- Lower extremity muscle strenght(Up to 11 weeks)
- Barthel Index (BI) score(Up to 11 weeks)
- Multiple Sclerosis Quality of Life-54 (MSQoL-54)(Up to 11 weeks)
- Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score(Up to 11 weeks)