Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.

NCT07062575 | Suspended

• 2 other identifiers: ABLEdailySCICIV-25-01-050614
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury. The experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (5)

• Safety of the device

  The total number of adverse events and serious adverse events related to the investigational device at the end of the study will be measured.

  Through study completion (up to 16 weeks)

• Performance of the device during the training period

  The number and type of device errors or use errors during the training period.

  Through the training period (up to 3 weeks) from training session 1-9

• Performance of the device in the home/community period

  The amount of use of the device during the home/community use period, as measured by the number of sessions and the walking time, number of steps, and distance walked per session.

  Through the home/community period (up to 12 weeks)

• Performance of the device in the home/community period

  The usability of the device as measured by the purpose and location of use of the device during the home/community use period which will be registered in a logbook by the participant.

  Through the home/community period (up to 12 weeks)

• Performance of the device in the home/community period

  The number and type of device errors at the end of the home/community use period will be registered.

  Through the home/community period (up to 12 weeks)

Secondary Outcomes (4)

• Perceived health status

  At baseline and the final assessment at end of the study (16 weeks)

• Gait performance while using the device (6MWT)

  After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)

• User satisfaction

  At the final assessment at the end of the study (16 weeks)

• Gait performance using the device: 10-Meter Walk Test (10MWT)

  After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)

Other Outcomes (13)

• Cardiovascular health

  Baseline assessment and at the final assessment at the end of the study (16 weeks)

• Respiratory Parameters

  Baseline assessment, during the 6 minute walk test and at the final assessment at the end of the study (16 weeks)

• Spasticity

  Baseline assessment, end of training period (3 weeks), final assessment at the end of the study (16 weeks)

Study Arms (1)

Intervention with exoskeleton

EXPERIMENTAL

The participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks.

Device: ABLE Daily

Interventions

ABLE Daily DEVICE

The participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks

Intervention with exoskeleton

Eligibility Criteria

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

You may qualify if:

• At least 18 years old
• Chronic SCI (\>6 months)
• Injury at levels T1 to L5 (AIS A to D)
• Walking Index for Spinal Cord Injury (WISCI) score 0 until 9
• Height between 150-200 cm
• Weight less than 100 kg
• Capable of giving informed consent on their own
• Able to train (at least) 3 days/week
• Able to have at least 1 companion / buddy who can attend a minimum of two of the training sessions, besides the final assessment, and who will learn how to assist them at home and in the community (ideally two companions)
• Proficiency in walking with the ABLE Exoskeleton
• At least 8 weeks with minimal use (less than 5 sessions) of wearable robotic exoskeletons for gait assistance at the start of the study.

You may not qualify if:

• High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip, distal femur, and proximal tibia BMD score
• Fragility fractures of the lower limbs in the last 2 years
• Deterioration \>3 in the International Standards for Neurological Classification of SCI (ISNCSCI) score in the last 4 weeks
• Spinal instability, like spondylolisthesis
• Disorders of the arms and hands that make walking with crutches impossible
• Modified Ashworth Scale (MAS) \>3 in lower limbs
• Cardiovascular health issues which prevent the participant from training
• Instability to tolerate 10 minutes of standing without clinical symptoms of orthostatic hypotension
• Psychological, cognitive issues, or any other condition that does not allow a participant to follow study procedures
• Medically unstable due to severe comorbidities, including any condition that a physician deems inappropriate for completing study participation
• Skin problems in areas that would be in contact with the device
• Height, width, weight, or other anatomical limitations (such as differences in leg length) incompatible with the device
• Insufficient joint range of motion (ROM) for the device
• Known pregnancy

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Sint Maartenskliniek: collaborator
• Universitat Politècnica de Catalunya: collaborator

Study Sites (1)

Sint Maartenskliniek

Hengstdal, Ubbergen, 6574NA, Netherlands

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Noel Keijsers

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: July 14, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)