Not provided
Not provided
Not provided
Not provided
Not provided
COVID-19
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Université de Montréal | OTHER |
| Université du Québec a Montréal | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable robotic exoskeleton-assisted walking program | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Robotic Exoskeleton for Ambulation | Device | 16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. | 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Not provided
Inclusion Criteria:
Exoskeleton-specific inclusion criteria:
Exclusion Criteria:
Exoskeleton-specific exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dany H. Gagnon, PT, PhD | Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM) | Montreal | Quebec | H2S 2J4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38357879 | Derived | Vincent C, Dumont FS, Rogers M, Hu T, Bass A, Aubertin-Leheudre M, Karelis AD, Morin SN, McKerral M, Duclos C, Gagnon DH. Perspectives of wheelchair users with chronic spinal cord injury following a walking program using a wearable robotic exoskeleton. Disabil Rehabil. 2024 Dec;46(25):6204-6212. doi: 10.1080/09638288.2024.2317994. Epub 2024 Feb 15. | |
| 38163294 |
Not provided
Not provided
Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in glycemic biomarkers | Glycemic (i.e., fasting glucose, insulin, glycosylated hemoglobin (Hb A1C)) biomarkers will be quantified using fasting blood samples. | 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. | 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. | 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. | 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 | Baseline at the initiation of the walking program (T1), at the end of the walking program (T2) |
| Bass A, Morin SN, Guidea M, Lam JTAT, Karelis AD, Aubertin-Leheudre M, Gagnon DH; Montreal Exoskeleton Walking Program (MEWP) Group. Potential Effects of an Exoskeleton-Assisted Overground Walking Program for Individuals With Spinal Cord Injury Who Uses a Wheelchair on Imaging and Serum Markers of Bone Strength: Pre-Post Study. JMIR Rehabil Assist Technol. 2024 Jan 1;11:e53084. doi: 10.2196/53084. |
| 32663160 | Derived | Bass A, Aubertin-Leheudre M, Vincent C, Karelis AD, Morin SN, McKerral M, Duclos C, Gagnon DH. Effects of an Overground Walking Program With a Robotic Exoskeleton on Long-Term Manual Wheelchair Users With a Chronic Spinal Cord Injury: Protocol for a Self-Controlled Interventional Study. JMIR Res Protoc. 2020 Sep 24;9(9):e19251. doi: 10.2196/19251. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
Not provided
Not provided