An interventional study of Wearable Robotic Exoskeleton for Ambulation in Spinal Cord Injuries, sponsored by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal · Not applicable, Interventional, and Prevention
Many individuals with a spinal cord injury (SCI) use a wheelchair as their primary mode of locomotion. The prolonged non-active sitting time associated to this mode of locomotion contributes to development or worsening of numerous adverse health effects affecting musculoskeletal, endocrino-metabolic and cardiorespiratory health. To counter this vicious circle, engaging in a walking program with a wearable robotic exoskeleton (WRE) is a promising physical activity intervention. This study aims to measure the effects of a WRE-assisted walking program on musculoskeletal, endocrino-metabolic and cardiorespiratory health.
Many individuals with a spinal cord injury (SCI) rely on manually propelled wheelchairs as their primary source of locomotion, leading to increased non-active sitting time, reduced physical activity and reduced lower extremity (L/E) weight bearing. This contributes to the development or worsening of complex and chronic secondary health problems, such as those affecting musculoskeletal (e.g., osteoporosis), endocrine-metabolic (e.g., hypertension, dyslipidemia, type 2 diabetes) and cardiorespiratory (e.g., poor aerobic fitness) health. Ultimately, these health problems may negatively affect functional capabilities and reduce quality of life.
Preliminary evidence has shown that engaging in a walking program with a wearable robotic exoskeleton (WRE) is a promising intervention. In fact, WRE-assisted walking programs promote L/E mobility and weight bearing (a crucial stimulus for maintaining bone strength in individuals with SCI), while also soliciting the trunk and upper extremity muscles and cardiorespiratory system.
This study aims to measure the effects of a WRE-assisted walking program on 1) bone strength, bone architecture and body composition, 2) endocrino-metabolic health profile and 3) aerobic capacity.
Twenty (20) individuals with a chronic (> 18 months) SCI will complete 34 WRE-assisted training sessions (1 h/session) over a 16-week period (1-3 sessions/week). Training intensity will be progressed (i.e., total standing time, total number of steps taken) periodically to maintain a moderate-to-vigorous intensity (≥ 12/20 on the Borg Scale). All training sessions will be supervised by a certified physical therapist.
Main outcomes will be measured one month prior to initiating the WRE-assisted walking program (T0), just before initiating the WRE-assisted walking program (T1), at the end of the WRE-assisted walking program (T2) and two months after the end of the WRE-assisted walking program (T3).
Descriptive statistics will be used to report continuous and categorical variables. The alternative hypothesis, stipulating that a pre-versus-post difference exists, will be verified using Repeated Mesures ANOVAs or Freidman Tests.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 16 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exoskeleton-specific inclusion criteria:
Exclusion Criteria:
Exoskeleton-specific exclusion criteria:
Total of 34 training sessions (60 min/session) during 16 weeks (1-3 session/week). Session intensity will be individualized and safely progressed thereafter (standing time, number of steps) to maintain a moderate-to-vigorous intensity (Borg rate of perceived exertion ≥12/20).
Device: Wearable Robotic Exoskeleton for Ambulation
16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist
Change in bone mass density (BMD) and architecture in the lower extremity
Areal BMD will be calculated with dual-energy X-ray absorptiometry (DXA) at the proximal tibial plateau, distal femur, femoral neck and the 1st to the 4th lumbar vertebrae. Volumetric BMD and microarchitecture parameters of the trabecular and cortical bones (mineral content, mineral density, cross-sectional area, cortical thickness) at the distal femur and proximal tibia will be captured with peripheral quantitative computed tomography (pQCT).
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
Change in body composition
DXA scans will be used to quantify total and regional body fat and fat free tissue mass (and relative percentages).
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
Change in muscle size
Cross-sectional images of the radius, tibia and femur captured with pQCT will be used to measure muscle cross-sectional area.
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
Change in intramuscular fat infiltration
Cross-sectional images of the radius, tibia and femur captured with pQCT will be used to measure intramuscular fat infiltration (i.e., muscle density).
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2), two months after the end of the walking program (T3)
Change in bone turnover biomarkers
Bone turnover (i.e., serum procollagen type I N-terminal peptide (P1NP), serum C-terminal cross-linking telopeptide (β-CTX) and 25-hydroxyvitamin D) biomarkers will be quantified using fasting blood samples.
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
Change in glycemic biomarkers
Glycemic (i.e., fasting glucose, insulin, glycosylated hemoglobin (Hb A1C)) biomarkers will be quantified using fasting blood samples.
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
Change in insulin resistance
Insulin resistance (hemeostatic model assessment (HOMA-1R)) will be quantified using fasting blood samples.
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
Change in lipide profile
Lipid (i.e. Total cholesterol, HDL, LDHL, tryglicerides, ApoB) biomarkers will be quantified using fasting blood samples.
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
Change in inflammatory biomarkers
Inflammatory (hsC-reactive protein, TNF-alpha, interleuken-6) biomarkers will be quantified using fasting blood samples.
Time frame: One month prior to intiating the walking program (T0), baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
Change in aerobic capacity
The Six-minute wheelchair propulsion test will be preformed with continuous expiratory gas analysis
Time frame: Baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
Plan to share: Yes — Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Icf
This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal