Retraining Walking Over Ground in a Powered Exoskeleton After Spinal Cord Injury, Edmonton, Alberta, 2014-2018 (ICPSR 37983)

Time Period(s) View help for Time Period(s)

Date of Collection View help for Date of Collection

Data Collection Notes View help for Data Collection Notes

Hide

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

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

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

Neurophysiological Outcomes

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 Index

Hide

Original Release Date View help for Original Release Date

2021-04-29

Hide