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| Name | Class |
|---|---|
| Praxis Spinal Cord Institute | OTHER |
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After partial spinal cord injury, gait deficits may be present and often remain even after intensive rehabilitation. New robotic technologies have recently emerged to help augment the extent of rehabilitation. However, these are complex tools to integrate into clinical practice and little is known about the potential factors that may influence the uptake of a locomotor program using this technology by clinicians. The goal of this project is to bring together researchers, administrators, clinicians and patients to define and implement an overground robotized gait training program in clinic. We will also investigate the added value of leg and trunk muscle stimulation combined with robotic walking training, to see if it could enhance recovery.
Powered exoskeleton technology represents a promising rehabilitation intervention for persons with incomplete spinal cord injury (iSCI). The overall aim of the present study is to investigate the implementability of an overground locomotor training program using a powered exoskeleton in persons with a subacute iSCI at the Institut de réadaptation en déficience physique de Québec, with and without functional electrical stimulation (FES). Over the 2-year period of the project, a logic model will be co-developed with stakeholders to support clinicians and administrators in the management of the locomotor training program. Using qualitative and quantitative research methods, we will evaluate the feasibility and perceived barriers/facilitators to the implementation in clinical practice of the training program. Finally, a pre-post design with individuals receiving the intervention either combined with FES or not, will allow quantifying of the benefits of combining FES in addition to robotic gait training on functional walking capacity in persons with a subacute iSCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLTP/PE+FES | Experimental | 3-5 familiarization sessions + 12 training sessions (3 blocks of 4 training sessions; 60-90 min each session, 2-3 sessions per week) of an overground locomotor training program using a powered exoskeleton combined with functional electrical stimulation (OLTP/PE+FES). The training sessions are divided into 3 blocks. Each block will take place over a period of approximately 2 weeks (2-3 sessions/week) and will consist of 3 training sessions with exoskeleton combined with FES and a fourth session with exoskeleton alone, without FES. For each participant, FES intensity will be set for each muscle in order to elicit a palpable muscle contraction. FES timing and duration is already built into the device. For each participant, specific level of assistance for each hip and knee, and gait parameters will be set and adjusted during a familiarization period with the PE. Level of PE assistance will then be adjusted weekly to ensure training progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLTP/PE + FES | Device | 12 sessions OLTP/PE + FES |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Six Minute Walk Test (6MWT) | A walking endurance test that measures the longest distance covered continuously during a maximum of six minutes. | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Change in 10 meter Walk Test (10mWT) | Measures preferred and maximal walking speeds over 10 meters | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Change in Modified Timed Up and Go test (TUG) | A functional test that assesses sit-to-stand transfers, balance and mobility | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Change in Walking Index for Spinal Cord Injury (WISCI-II) | functional walking capacity scale that describes the amount of physical assistance, braces or devices required to walk 10 meters | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief pain inventory questionnaire | Intensity of pain | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS) |
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Inclusion Criteria:
General
For FES:
Exclusion Criteria:
General:
FES Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| François Routhier, PhD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University | Québec | Quebec | Canada |
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This scale specifically targets secondary conditions associated with SCI that directly and indirectly impact health and physical functioning. The rating scale uses a 4-point ordinal scale ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem). Total scores range from 0 to 48. Higher scores indicate greater overall problems with secondary conditions
| 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Change in the Modified Ashworth Scale (MAS) | A measure of lower limb spasticity. Scores range from 0 to 4. Higher scores indicate greater spasticity. scale. | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |
| Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system. | Muscle activation patterns (i.e., amplitude, timing) and muscle fatigue (reduction in the median frequency of the EMG power spectrum) will be documented. | 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) |