Clinical trial NCT06306352: Vibrotactile Feedback in Exoskeletons
Official title: The Effect of Vibrotactile Feedback on Exoskeleton Use in People With Motor Complete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Exoskeletons
Sensory substitution
Vibrotactile feedback
Motor control
Motor learning
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: ABLE Human Motion S.L.
name: Netherlands Organisation for Scientific Research
First posted: 2024-03-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking distance covered
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Reach path ratio
timeFrame: Up to 3 weeks
measure: Reach time
timeFrame: Up to 3 weeks
measure: User experience questionnaire
timeFrame: After 3 weeks
measure: 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
timeFrame: After 3 weeks
Other outcomes:
measure: Dutch System Usability Scale (D-SUS)
timeFrame: After 3 weeks
Locations:
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Noël Keijsers
role: PRINCIPAL_INVESTIGATOR
References: