Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of an Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With a Chronic Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Wearable Robotic Exoskeleton for Ambulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic or non-traumatic spinal cord injury between C6 and T10 neurological level at least 18 months pre-enrollment Long-term wheelchair use as primary means of mobility (non-ambulatory) Normal cognition (Montreal Cognitive Assessment Score ≥26/30) Understand and communicate in English of French Reside in the community within 75 km of the research site Exoskeleton-specific inclusion criteria: Body mass ≤100 kg Height=1.52-1.93 m Pelvis width=30-46 cm Thigh length=51-61.4 cm Lower leg length=48-63.4 cm Standing tolerance ≥30 minutes with full lower extremity weight-bearing Exclusion Criteria: Other neurological impairments aside from those linked to the spinal cord injury (e.g., severe traumatic brain injury) Concomitant or secondary musculoskeletal impairments (e.g., hip heterotopic ossification) History of lower extremity fracture within the past year Unstable cardiovascular or autonomic system Pregnancy Any other other conditions that may preclude lower extremity weight-bearing, walking, or exercise tolerance in the wearable robotic exoskeleton Exoskeleton-specific exclusion criteria: Inability to sit with hips and knees ≥90° flexion Lower extremity passive range of motion limitations (hip flexion contracture ≥5°, knee flexion contracture ≥10°, and dorsiflexion ≤-5° with knee extended) Moderate-to-sever lower extremity spasticity (>3 modified Ashworth score) Length discrepancy (≥1.3 or 1.9 cm at the thigh or lower leg segment) Skin integrity issues preventing wearing the robotic exoskeleton

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable robotic exoskeleton-assisted walking program<br>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<br>* 16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assistive Technology, Locomotion, Rehabilitation, Robotics