Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting

Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Acquired Brain Injury in a Clinical Setting

The primary objective of the study is to validate the safety and clinical performance of the ABLE Exoskeleton device in people with acquired brain injury during a 10-session gait training program in a clinical setting.

The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.

This is a pre-post, multicenter, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at the Centro Europeo de Neurociencias (CEN), Cefine Neurología (CEFINE), and Fundación Step by Step Foundation, where a minimum of 15 participants (5 per center) are expected to be recruited within a period of 8 weeks.

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 baseline assessment without the medical device.

Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 6 weeks. Sessions will be conducted 2 times per week. 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.

Inclusion Criteria:

• 18 to 80 years old
• Diagnosed with acquired brain injury (ABI)
• Currently undergoing outpatient physical therapy treatment in one of the investigation sites
• Ability to give informed consent

Exclusion Criteria:

• 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 10 minutes standing
• Uncontrolled autonomic dysreflexia
• Medical instability
• Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP>140, DBP>90 mmHg), unresolved deep venous thrombosis (DVT), uncontrolled autonomic dysreflexia
• 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 leg 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
• Requires assisted ventilation.
• Scoliosis >40-50º Cobb angle.