Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study
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|ClinicalTrials.gov Identifier: NCT03144830|
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Exoskeleton||Not Applicable|
Study participants with acute SCI (<6 months post injury) will be involved in an indoor, overground walking program.
Locomotor training will include 90 minute sessions (including time to don and doff the device) for 30 training hours (90 minutes, 2-3 times weekly for 8 weeks.)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Overground walking program
Study participant will be involved in an indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist.
This is an open study and so all participants involved with be using the exoskeleton to determine the safety and feasibility of its use during the acute rehabilitation phase.
Other Name: Ekso GT
- Change from baseline cardiorespiratory status throughout each of the 25 sessions [ Time Frame: Every 15 minutes during each training session including: pre and post initial stand, at 15 minute intervals during training and at the end of each of the 25 total sessions, on average of 2 months ]Blood pressure, heart rate and peripheral oxygen saturation and will be used to identify any cardiovascular issues of orthostatic hypotension or autonomic dysreflexia.
- Skin integrity [ Time Frame: At the beginning and end of each training session for 25 sessions, on average of 2 months ]A visual inspection of areas of significant weight bearing and skin/machine interface will take place at the beginning and end of each training session to monitor for skin breakdown or compromise.
- Falls [ Time Frame: From onset to cessation of each training session for 25 sessions, on average of 2 months ]Any incidence of falls will be recorded and the participant will be evaluated for injury by unit medical staff or on site emergency staff if warranted.
- Pain visual analogue scale [ Time Frame: At the beginning and end of each training session for 25 sessions, on average of 2 months ]Participants draw an intersecting line on a 10 cm line (scale) in order to rate their amount of subjective pain. The distance on the 10 cm line is measured from the left side (no pain) and turned into a numerical value.
- Borg scale of perceived exertion [ Time Frame: At the beginning, mid point (30 min) and end (60 min) of each training session for 25 sessions, on average of 2 months ]Subjects are shown the Borg scale of perceived exertion and are asked to choose the number/descriptor that best aligns with their current level of exertion at 0, 30 and 60 minutes.
- 10 meter walk test [ Time Frame: Training sessions 1, 13 and 25 out of the 25 total sessions, on average of 2 months ]Time in seconds it takes a subject to walk a distance of 10 meters.
- 6 minute walk test [ Time Frame: Training sessions 1, 13 and 25 of the 25 total sessions, on average of 2 months ]Total distance a participant is able to walk in 6 minutes will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144830
|Contact: Chester Ho, MD||(403) 944 firstname.lastname@example.org|
|Contact: Kyle McIntosh, MScPT||(403) 944 email@example.com|
|Foothills Medical Centre||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Contact: Kyle J McIntosh, MScPT 403-944-5358 firstname.lastname@example.org|
|Principal Investigator:||Chester Ho, MD||University of Calgary|