Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2023-03-06
2023-06-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Vibrotactile feedback
Participants will receive vibrotactile feedback in the ABLE Exoskeleton.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Minimally six months post-injury
* Prior experience with the ReWalk Exoskeleton, able to walk independently
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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ABLE Human Motion S.L.
INDUSTRY
Netherlands Organisation for Scientific Research
OTHER_GOV
Sint Maartenskliniek
OTHER
Responsible Party
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Principal Investigators
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Noël Keijsers
Role: PRINCIPAL_INVESTIGATOR
Sint Maartenskliniek
Locations
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Sint Maartenskliniek
Nijmegen, , Netherlands
Countries
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Other Identifiers
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NL82999.091.22
Identifier Type: OTHER
Identifier Source: secondary_id
1070
Identifier Type: -
Identifier Source: org_study_id
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