Vibrotactile Feedback in Exoskeletons

March 5, 2024 updated by: Sint Maartenskliniek

The Effect of Vibrotactile Feedback on Exoskeleton Use in People With Motor Complete Spinal Cord Injury

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: People with motor-complete spinal cord injury (SCI) lack motor function below the lesion level and are, thus, wheelchair-dependent. In recent years, wearable exoskeletons have emerged as potential mobility devices for this population. Although exoskeletons generate the basic motions for ambulation, postural stability must be maintained by the user. People with motor-complete SCI miss essential somatosensory perception, which affects their ability to maintain postural stability. Hence, walking in an exoskeleton is demanding, and crutches are necessary.

When sensory information of a specific system is lost, the lack of sensory information can be substituted by providing feedback to another sensory system. As sensory feedback has been shown to improve postural control in people missing essential sensory information, such sensory substitution may also be effectively incorporated in people with complete SCI using an exoskeleton.

Objective: The study aims to investigate the effect of vibrotactile feedback on exoskeleton use in people with motor-complete SCI.

Study design: The proposed study is an experimental study. The study protocol includes six sessions of 90 minutes spread over three weeks. Sessions one to five are dedicated to training to assess the effect of vibrotactile feedback on exoskeleton motor learning. Session six is dedicated to evaluation to assess the effect of vibrotactile feedback on exoskeleton motor control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Sint Maartenskliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vibrotactile feedback
Participants will receive vibrotactile feedback in the ABLE Exoskeleton.
Other: Vibrotactile feedback
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Walking distance covered
Time Frame: Up to 3 weeks
Walking distance covered during a 50-second walking trial.
Up to 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reach path ratio
Time Frame: Up to 3 weeks
The reach path ratio of the Center of Mass (COM) trajectory in the double support phase.
Up to 3 weeks
Reach time
Time Frame: Up to 3 weeks
The reach time represents the time spent in the double support phase.
Up to 3 weeks
User experience questionnaire
Time Frame: After 3 weeks
A customized questionnaire to assess the specific user experience of the vibrotactile feedback system, considering key aspects related to exoskeleton motor learning and motor control. The questionnaire comprises five visual analog questions employing a scale ranging from strongly disagree to strongly agree
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
Time Frame: After 3 weeks
The D-QUEST evaluates a patient's satisfaction with various assistive technologies.
After 3 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dutch System Usability Scale (D-SUS)
Time Frame: After 3 weeks
The SUS is a questionnaire-based method to assess the usability of a system or product through a series of standardized questions.
After 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sint Maartenskliniek

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Netherlands Organisation for Scientific Research
ABLE Human Motion S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noel Keijsers, Sint Maartenskliniek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1070 (Other Identifier: Ege University Health Sciences Scientific Research and Publication Ethics Committee)
  • NL82999.091.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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