Spinal Cord Injuries
Conditions
Keywords
Exoskeletons, Sensory substitution, Vibrotactile feedback, Motor control, Motor learning
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.
Interventions
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.
Sponsors
ABLE Human Motion S.L.
Netherlands Organisation for Scientific Research
Sint Maartenskliniek
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking distance covered | Up to 3 weeks | Walking distance covered during a 50-second walking trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dutch System Usability Scale (D-SUS) | 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. |
Countries
Netherlands
Outcome results
None listed