NCT05643313

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 and easier to use. The primary objective of this study is to determine the feasibility and usability of the ABLE Exoskeleton for persons with SCI to perform skills in home and community environments.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

November 25, 2022

Last Update Submit

October 18, 2023

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord InjuryExoskeletonRoboticsGait RehabilitationLower-limbNeurorehabilitationParaplegiaWalkingAssistive technologyUsabilityFeasibilityHome useCommunity useMulticenter

Outcome Measures

Primary Outcomes (7)

  • Time and Level of Assistance (LoA) to don/doff the device [Usability/Feasibility]

    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 the patient and the therapist in performing the activity.

    Up to 11 weeks

  • LoA to complete skills for home and community environments [Usability/Feasibility]

    The participant will attempt a set of skills for home and community environments every session to assess the device's usability. The therapist will record the LoA required to complete each task during every session. The best LoA-Score of all 15 tasks within 3 consecutive training sessions will be recorded and analysed (sessions 2-4, sessions 5-7, sessions 8-10, sessions 11-14, sessions 15-17, sessions 18-20).

    Up to 11 weeks

  • Tme to complete Home-Skills-Test and LoA for each task and ti [Usability/Feasibility]

    A Home-skills-test will be performed by all participants and will consist of 10 of the skills for home and community environments, set out in a sequence to simulate daily life situations. The test will be attempted twice with a 5 min break in between, the best result will be documented. To assure safety, participants will attempt the test with assistance from the therapist as required. For all skills of the Home-skills-test, the LoA to complete each task and the time to complete the test will be documented.

    Up to 11 weeks

  • Number of steps taken with the device [Usability/Feasibility]

    The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

    Up to 11 weeks

  • Distance walked with the device [Usability/Feasibility]

    The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

    Up to 11 weeks

  • Walking time with the device [Usability/Feasibility]

    The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

    Up to 11 weeks

  • Standing time in the device [Usability/Feasibility]

    The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

    Up to 11 weeks

Secondary Outcomes (10)

  • BORG Scale [Perceived rate of exertion]

    Up to 11 weeks

  • 6-Minute Walk Test (6 MWT) [Gait and function]

    Up to 11 weeks

  • 10-Meter Walking Test (10 MWT) [Gait and function]

    Up to 11 weeks

  • Timed up and go test (TUG) [Gait and function]

    Up to 11 weeks

  • Walking Index for Spinal Cord Injury (WISCI II) [Gait and function]

    Up to 11 weeks

  • +5 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Participants will then undergo a training programme with the ABLE Exoskeleton three to five times a week for up to 8 weeks for a total of 18 training sessions and 4 assessment sessions.

Device: ABLE Exoskeleton

Interventions

ABLE ExoskeletonDEVICE

The ABLE Exoskeleton is a lower-limb overground robotic exoskeleton intended for SCI patients for rehabilitation in a clinical setting.

Treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years of age
  • Traumatic and non-traumatic SCI
  • Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or, Motor Complete SCI with NLI T1-L5
  • Time since onset of SCI \> 6 months
  • Ability to give informed consent

You may not qualify if:

  • WISCI II without exoskeleton of \>13
  • or more risk factors present for fragility as stated by Craven et al (Craven et al., 2009a).
  • History of lower limb fragility fractures in the last 2 years
  • Deterioration \> 3 points of the total ISNCSCI motor score within the last 4 weeks
  • Spinal instability
  • Modified Ashworth scale 4 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 the participant to follow the study procedures
  • Known pregnancy or breastfeeding
  • Any neurological condition other than SCI
  • Medically unstable - Unstable cardiovascular system, hemodynamic instability, untreated hypertension (Systolic blood pressure \> 140, Diastolic blood pressure \> 90 mmHg), unresolved DVT, uncontrolled autonomic dysreflexia.
  • Severe comorbidities - Any condition that a physician considers to not be appropriate to complete participation in the study.
  • Ongoing skin issues - Grade I or higher on EPUAP on areas that will be in contact with exoskeleton (European Pressure Ulcer Advisory Panel, 2019)
  • Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the device
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Spinal Cord Injury Center | Heidelberg University Hospital

Heidelberg, 69118, Germany

Location

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

  • Nadorf F, Wright MA, Lopez-Matas H, Porras E, Carnicero-Carmona A, Hensel C, Franz S, Weidner N, Vidal J, Opisso E, Rupp R. User-centered design of a personal-use exoskeleton: a clinical investigation on the feasibility and usability of the ABLE Exoskeleton device for individuals with spinal cord injury to perform skills for home and community environments. Front Neurosci. 2024 Sep 26;18:1437358. doi: 10.3389/fnins.2024.1437358. eCollection 2024.

    PMID: 39391753DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesParaplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 8, 2022

Study Start

November 25, 2022

Primary Completion

August 28, 2023

Study Completion

August 28, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)DE(1)