Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton

NCT07550699 | Recruiting

• 1 other identifier: ABLEexoFES
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury; Multiple Sclerosis; Acquired Brain Injury (Including Stroke)

Keywords

Gait training; Wearable exoskeleton; Acquired Brain Injury; Lower-limb exoskeleton; Spinal Cord Injury; Multiple Sclerosis; Functional Electrical Stimulation (FES); Robotic exoskeleton; Hybrid exoskeleton-FES system

Outcome Measures

Primary Outcomes (11)

• Number and type of device-related Adverse Events

  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.

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

• Time taken to don/doff the device

  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.

  Up to 5 weeks (8 sessions)

• Number of steps walked

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

  Up to 5 weeks (8 sessions)

• Distance walked

  In each gait training session, the distance walked with the device will be automatically measured and recorded by the device and reported in meters.

  Up to 5 weeks (8 sessions)

• Time spent upright and time spent walking

  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.

  Up to 5 weeks (8 sessions)

• Number of therapists assisting the session

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

  Up to 5 weeks (8 sessions)

• Assistive device used

  In each gait training session, the assistive device used (walker, crutches, cane, second therapist, etc) will be recorded.

  Up to 5 weeks (8 sessions)

• Step Length

  Step length (in cm) will be automatically measured and recorded during each gait training session by the device.

  Up to 5 weeks (8 sessions)

• Step Symmetry

  Step symmetry (in %) will be automatically measured and recorded during each gait training session by the device.

  Up to 5 weeks (8 sessions)

• Center of mass displacement (cm)

  In each gait training session, the center of mass displacement (cm) will be automatically measured and registered by the device

  Up to 5 weeks (8 sessions)

• Motor torque (Nm)

  In each gait training session, the motor torque (Nm) will be automatically measured and registered by the device

  Up to 5 weeks (8 sessions)

Secondary Outcomes (7)

• 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)

Study Arms (1)

Gait training with ABLE Exoskeleton + Functional Electrical Stimulation (ABLE FES)

EXPERIMENTAL

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.

Device: ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES)

Interventions

ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES) DEVICE

A robotic lower-limb exoskeleton integrated with functional electrical stimulation (ABLE FES) used for gait rehabilitation training.

Gait training with ABLE Exoskeleton + Functional Electrical Stimulation (ABLE FES)

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• therapy2people GmbH: collaborator

Study Sites (1)

therapy2people GmbH

Vienna, State of Vienna, 1220, Austria

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Spinal Cord Injuries; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Peter Lackner, Dr.

CONTACT

+43 681 207 41241; peter@tech2people.at

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: April 16, 2026
• First Posted: April 24, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)