NCT06306352

Brief Summary

This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

February 28, 2024

Last Update Submit

March 5, 2024

Conditions

Spinal Cord Injuries

Keywords

ExoskeletonsSensory substitutionVibrotactile feedbackMotor controlMotor learning

Outcome Measures

Primary Outcomes (1)

  • Walking distance covered

    Walking distance covered during a 50-second walking trial.

    Up to 3 weeks

Secondary Outcomes (4)

  • Reach path ratio

    Up to 3 weeks

  • Reach time

    Up to 3 weeks

  • User experience questionnaire

    After 3 weeks

  • Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device

    After 3 weeks

Other Outcomes (1)

  • Dutch System Usability Scale (D-SUS)

    After 3 weeks

Study Arms (1)

Vibrotactile feedback

EXPERIMENTAL

Participants will receive vibrotactile feedback in the ABLE Exoskeleton.

Other: Vibrotactile feedback

Interventions

Vibrotactile feedbackOTHER

The ABLE exoskeleton is accompanied by a vibrotactile feedback belt which users wear around their chest to receive real-time feedback during the double support phase. This feedback can assist them in their weight shift during the double support phase.

Vibrotactile feedback

Eligibility Criteria

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

You may qualify if:

  • SCI classification American Spinal Injury Association Impairment Scale (AIS) A or B
  • Minimally six months post-injury
  • Prior experience with the ReWalk Exoskeleton, able to walk independently

You may not qualify if:

  • Pre-existing somatosensory problems before the SCI
  • Visual or auditory issues that are not resolved with glasses or a hearing device
  • Insufficient mastery of the Dutch language
  • Contraindications related to the ABLE Exoskeleton

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Maartenskliniek

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Noël 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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 12, 2024

Study Start

March 6, 2023

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)