Retraining Walking Over Ground in a Powered Exoskeleton After Spinal Cord Injury, Edmonton, Alberta, 2014-2018 (ICPSR 37983)
Version Date: Apr 29, 2021 View help for published
Summary View help for Summary
This was a mixed-methods study to determine quantitative and qualitative outcomes in a cohort of individuals with chronic, spinal cord injury, who learned to use the ReWalk exoskeleton to walk over ground. Researchers determined the training dosage required for walking proficiency, the sensory and motor changes in the nervous system with the training, and the perspectives of the participants with respect to both the training and the device. It was a prospective cohort study. Measures were taken before, during, immediately after training, and 2-3 months after training was completed.
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Restrictions View help for Restrictions
The qualitative data are potentially identifiable and may not be used for any purpose other than statistical reporting and analysis. Use of these data to learn the identity of any person or establishment is prohibited. To protect respondent privacy, these files are restricted from general dissemination. To obtain these files, researchers must agree to the terms and conditions of a Restricted Data Use Agreement in accordance with existing ICPSR servicing policies.
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Data Collection Notes View help for Data Collection Notes
These data are distributed as they were received from the data depositor. The files have been zipped for release, but not checked or processed except for the removal of certain identifiers. Users should refer to the accompanying readme file for a brief description of the files available with this collection.
Study Purpose View help for Study Purpose
A mixed-methods study to determine quantitative and qualitative outcomes in a cohort of individuals with chronic, spinal cord injury, who learned to use the ReWalk exoskeleton to walk over ground. Researchers determined the training dosage required for walking proficiency; the sensory and motor changes in the nervous system with the training; and the perspectives of the participants with respect to both the training and the device.
Study Design View help for Study Design
The expectations and experiences of the participants regarding the training and the device were obtained through one-on-one, semi-structured interviews. Interviews were conducted before, immediately after, and 2-3 months following the end of training. Interviews were audio recorded and transcribed verbatim. A six stage approach to thematic analysis was used. It was a prospective cohort study. Measures were taken before, during, immediately after training, and 2-3 months after training was completed.
Sample View help for Sample
The participants in this study were a sample of convenience of individuals who were made aware of the study either through practicing clinicians in the community; non-profit organizations such as SCI-Alberta; through word-of-mouth; or through websites such as clinicaltrials.gov.
Time Method View help for Time Method
Universe View help for Universe
Individuals with severe spinal cord injury who resided, or maintained temporary residence for the purpose of the study, in Edmonton, Alberta, Canada. Further criteria required at least one year since qualifying injury; wheelchair use as primary mode of locomotion; and with sufficient arm strength to control forearm crutches.
Unit(s) of Observation View help for Unit(s) of Observation
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Description of Variables View help for Description of Variables
Measurements During Training
The following measurements were collected during each training session.
- The total number of steps taken
- Walking distance
- Average walking speed
- Steps per bout of walking without stopping
- Total duration of the session
- The participant's subjective perception of pain (quantified before and after each training session using a numerical rating scale)
Clinical Outcome Measures
The following measures were collected before, during, and after the training period. Different measures were taken at different frequencies. Details associated with each measure is documented in Word files that accompany the specific data files.
- Walking speed was measured over 10 meters using a modified 10-m Walk Test
- Walking distance was quantified with the 6-min Walk Test
- Physiological Cost Index was estimated during the 6-min Walk Test
- Manual muscle strength was quantified according to the International Standards for Neurological Classification of Spinal Cord Injury
- Spasticity was quantified with the Spinal Cord Assessment Tool for Spasticity (SCATS)
- Neuropathic pain was quantified with the McGill Pain Questionnaire Rating Index
The following neurophysiological measures were measured before, during and immediately after training.
- Sitting balance was measured with the participants sitting on a force platform (Model OR6-7-1000, AMTI, Watertown, MA). Both the postural sway and the limits-of-stability were quantified using the center of pressure recorded on the force plate
- Strength of skin sensation was measured by surface electrical stimulation at the C3-S2 sensory key points defined by ISNCSCI
- Strength of descending motor pathways was quantified using single-pulse transcranial magnetic stimulation (Magstim 200, Whitland, UK) of the motor cortex to the back extensor muscles
Response Rates View help for Response Rates
The overall response rate was 50% of qualifying individuals. Fifty-one potential participants were screened. Twenty-seven were excluded due to inclusion/exclusion criteria. Twelve of the remaining twenty-four participants agreed to enroll in the study.
Presence of Common Scales View help for Presence of Common Scales
Physiological Cost Index; International Standards for Neurological Classification of Spinal Cord Injury; Spinal Cord Assessment Tool for Spasticity (SCATS); McGill Pain Questionnaire Rating IndexHide
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.