Clinical Investigation on Safety, Feasibility and Usability of the ABLE Exoskeleton Device With Spinal Cord Injured Patients in a Hospital Setting

NCT04876794 | Completed

• 2 other identifiers: ABLEexoSCIhospitalCIV-20-07-034264
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief Summary

The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians. Exoskeletal technology has the potential to help people with impaired leg function to regain ambulation and thus improve their independence. This technology is not completely new, but due to their high access price (\~120k€/unit), high size and weight (\~25 kg), and need for trained physiotherapist supervision, commercially available exoskeletons are only found in large hospitals and only in very few cases get into patients' homes. The company ABLE Human Motion S.L. (Barcelona, Spain) has developed a novel exoskeleton to overcome these disadvantages, which is more compact, lighter (9 kg) and easier to use. The primary objective of the study is to investigate the safety, feasibility and usability of the ABLE exoskeleton device in people with spinal cord injury during a four to six weeks gait training in clinical settings. Furthermore, potential effects of the training on walking, general health status, user satisfaction, and quality of life will be assessed.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Exoskeleton; Robotics; Gait; Rehabilitation; Lower-limb; Neurorehabilitation; Paraplegia; Walking; Assistive technology; Usability; Safety; Feasibility; Multicenter

Outcome Measures

Primary Outcomes (3)

• Safety

  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.

  Up to 10 weeks

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

  Level of Assistance (LoA) and time taken to don/doff the device will be measured in every session. LoA will be measured using a 6 item scale, from Total assistance to Independence. Different assistance levels are defined taking into account the degree of participation of both the patient and the therapist on performing the activity. This outcome measure will be used to assess the device's usability.

  Up to 8 weeks

• Level of Assistance (LoA) to complete therapy activity tasks

  Four therapy activity tasks will be attempted every session by the participant. The therapist will record the LoA required to complete each task during the session. The tasks are the following: sit-to-stand, walk 10 meters, turn 180 degrees, and stand-to-sit. Different assistance levels are defined taking into account the degree of participation of both the patient and the therapist in performing the activity. This outcome measure will be used to assess the device's usability.

  Up to 8 weeks

Secondary Outcomes (8)

• BORG Scale

  Up to 7 weeks

• 6-Minute Walk Test (6 MWT)

  Up to 7 weeks

• 10-Meter Walking Test (10 MWT)

  Up to 7 weeks

• Timed up and go test (TUG)

  Up to 7 weeks

• Walking Index for Spinal Cord Injury (WISCI II)

  Up to 7 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions.

Device: ABLE Exoskeleton

Interventions

ABLE Exoskeleton DEVICE

Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions.

Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age
• Traumatic and non-traumatic SCI
• Currently receiving treatment as an inpatient or outpatient at one of the investigational sites
• AIS A to AIS D with sufficient arm strength to support body weight on a walking frame
• Ability to give informed consent

You may not qualify if:

• WISCI II without exoskeleton of \>16
• or more risk factors for fragility as stated by Craven et al (29)
• History of lower limb fragility fractures in the last 2 years
• Deterioration \> 3 points of the total International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor score within the last 4 weeks
• Spinal instability
• Modified Ashworth scale (MAS) \> 3 in lower limbs
• Unable to tolerate 30 min standing without clinical symptoms of orthostatic hypotension
• Unable to perform a sit-to-stand transfer or stand in the device with assistance
• Psychological or cognitive issues that do not allow a participant to follow the study procedures
• Any neurological condition other than SCI
• Medically unstable
• Severe comorbidities including any condition that a physician considers to not be appropriate to complete participation in the study
• Ongoing skin issues
• Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device
• Insufficient Range of Motion (ROM) for ABLE Exoskeleton device

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Institut Guttmann: collaborator
• Heidelberg University Hospital Spinal Cord Injury Center: collaborator

Study Sites (2)

Spinal Cord Injury Center | Heidelberg University Hospital

Heidelberg, 69118, Germany

Location

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rüdiger Rupp, PD Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

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 30, 2021
• First Posted: May 6, 2021
• Study Start: November 3, 2020
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (1)