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Completed

NCT Number: NCT06306352

Vibrotactile Feedback in Exoskeletons

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek

Nijmegen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Walking distance covered

    Time frame: Up to 3 weeks

    Walking distance covered during a 50-second walking trial.

Secondary outcomes

  1. 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.

  2. Reach time

    Time frame: Up to 3 weeks

    The reach time represents the time spent in the double support phase.

  3. 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

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Collaborators

  • ABLE Human Motion S.L.
  • Netherlands Organisation for Scientific Research

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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