Vibrotactile Feedback in Exoskeletons

Not Applicable

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT06306352
• Lead Sponsor: Sint Maartenskliniek

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.

Study Timeline

• Study Start: 2023-03-06
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21
• Study First Submitted: 2024-02-28
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Walking distance covered	Up to 3 weeks	Walking distance covered during a 50-second walking trial.

Secondary Outcome Measures

Name	Time	Method
User experience questionnaire	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
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	The D-QUEST evaluates a patient's satisfaction with various assistive technologies.
Reach path ratio	Up to 3 weeks	The reach path ratio of the Center of Mass (COM) trajectory in the double support phase.
Reach time	Up to 3 weeks	The reach time represents the time spent in the double support phase.

Trial Locations

Locations (1)

Sint Maartenskliniek; 🇳🇱 Nijmegen, Netherlands