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

NCT07050875 | Completed

• 2 other identifiers: ABLEexoABICIV-25-04-052374
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acquired Brain Injury (Including Stroke)

Keywords

Gait training; Wearable exoskeleton; Acquired Brain Injury; Lower-limb exoskeleton; Multicenter

Outcome Measures

Primary Outcomes (8)

• Number and type of device-related Adverse Events

  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.

  From baseline to follow-up (up to 2 weeks after end of intervention)

• Level of Assistance (LoA) to don/doff the device

  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.

  Up to 6 weeks

• Time taken to don/doff the device

  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.

  Up to 6 weeks

• Number of steps walked

  In each gait training session, the number of steps taken (step count) with the device will be automatically measured and registered by the device

  Up to 6 weeks

• Distance walked

  In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device

  Up to 6 weeks

• Time spent upright and time spent walking

  In each gait 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

  Up to 6 weeks

• Number of therapists assisting the session

  In each gait training session, the number of therapists assisting will be recorded

  Up to 6 weeks

• Level of Assistance (LoA) during training

  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.

  Up to 6 weeks

Secondary Outcomes (15)

• Lower extremity muscle strenght

  At baseline (day 0) and post-training (up to 7 weeks)

• Functional Ambulation Category (FAC)

  At baseline(day 0) and post-training (up to 7 weeks)

• 10-Meter Walking Test (10MWT)

  At baseline(day 0) and post-training (up to 7 weeks)

• 6-Minute Walk Test (6MWT)

  At baseline (day 0) and post-training (up to 7 weeks)

• Timed Up and Go (TUG)

  At baseline (day 0) and post-training (up to 7 weeks)

Study Arms (1)

Gait training with exoskeleton

EXPERIMENTAL

Participants will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes.

Device: ABLE Exoskeleton

Interventions

ABLE Exoskeleton DEVICE

Participants will undergo a 10-session gait training program with the exoskeleton, twice a week for up to 6 weeks. Each session will last 60 minutes.

Gait training with exoskeleton

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Centro Europeo de Neurociencias (CEN): collaborator
• Cefine Neurología (CEFINE): collaborator
• Fundación Step by Step (SBS): collaborator

Study Sites (3)

Cefine Neurología (CEFINE)

Culleredo, A Coruña, 15174, Spain

Location

Fundación Step by Step

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Centro Europeo de Neurociencias (CEN)

Madrid, Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 3, 2025
• Study Start: June 30, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)