Vibrotactile Feedback in Exoskeletons

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06306352
• Other study ID #: 1070
• Secondary ID: NL82999.091.22
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: June 21, 2023

Study information

• Verified date: March 2024
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Nijmegen

Sponsors (3)

Lead Sponsor	Collaborator
Sint Maartenskliniek	ABLE Human Motion S.L., Netherlands Organisation for Scientific Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Walking distance covered	Walking distance covered during a 50-second walking trial.	Up to 3 weeks
Secondary	Reach path ratio	The reach path ratio of the Center of Mass (COM) trajectory in the double support phase.	Up to 3 weeks
Secondary	Reach time	The reach time represents the time spent in the double support phase.	Up to 3 weeks
Secondary	User experience questionnaire	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
Secondary	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	The D-QUEST evaluates a patient's satisfaction with various assistive technologies.	After 3 weeks