Vibrotactile Feedback in Exoskeletons | NCT06306352

Studies
Vibrotactile Feedback in Exoskeletons

NCT06306352

Sponsor

Sint Maartenskliniek

Status

Completed

Last Update Posted

Mar 12, 2024Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Spinal Cord Injuries

Interventions

Vibrotactile feedback

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NL82999.091.22	Other Identifier	CCMO

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2023Actual

Primary Completion Date

Jun 21, 2023Actual

Completion Date

Jun 21, 2023Actual

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 12, 2024Actual

Name	Class
ABLE Human Motion S.L.	INDUSTRY
Netherlands Organisation for Scientific Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vibrotactile feedback	Experimental	Participants will receive vibrotactile feedback in the ABLE Exoskeleton.	Other: Vibrotactile feedback

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vibrotactile feedback	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Walking distance covered	Walking distance covered during a 50-second walking trial.	Up to 3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Reach path ratio	The reach path ratio of the Center of Mass (COM) trajectory in the double support phase.	Up to 3 weeks
Reach time	The reach time represents the time spent in the double support phase.

Other Outcomes

Measure	Description	Time Frame
Dutch System Usability Scale (D-SUS)	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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noël Keijsers	Sint Maartenskliniek	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sint Maartenskliniek		Nijmegen			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

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Browse Branches

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