Sint Maartenskliniek
Nijmegen, Netherlands
NCT Number: NCT06306352
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nijmegen, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 3 weeks
Walking distance covered during a 50-second walking trial.
Time frame: Up to 3 weeks
The reach path ratio of the Center of Mass (COM) trajectory in the double support phase.
Time frame: Up to 3 weeks
The reach time represents the time spent in the double support phase.
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
Time frame: After 3 weeks
The D-QUEST evaluates a patient's satisfaction with various assistive technologies.
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.
Sint Maartenskliniek
Other
The Effect of Vibrotactile Feedback on Exoskeleton Use in People With Motor Complete Spinal Cord Injury
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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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