- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989752
Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury
Effects of an Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With a Chronic Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H2S 2J4
- Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Wearable robotic exoskeleton-assisted walking program
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).
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16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone mass density (BMD) and architecture in the lower extremity
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)
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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).
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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)
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Change in body composition
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)
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DXA scans will be used to quantify total and regional body fat and fat free tissue mass (and relative percentages).
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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)
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Change in muscle size
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)
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Cross-sectional images of the radius, tibia and femur captured with pQCT will be used to measure muscle cross-sectional area.
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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)
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Change in intramuscular fat infiltration
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)
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Cross-sectional images of the radius, tibia and femur captured with pQCT will be used to measure intramuscular fat infiltration (i.e., muscle density).
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone turnover biomarkers
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)
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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.
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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)
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Change in glycemic biomarkers
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)
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Glycemic (i.e., fasting glucose, insulin, glycosylated hemoglobin (Hb A1C)) biomarkers will be quantified using fasting blood samples.
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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)
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Change in insulin resistance
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)
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Insulin resistance (hemeostatic model assessment (HOMA-1R)) will be quantified using fasting blood samples.
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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)
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Change in lipide profile
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)
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Lipid (i.e.
Total cholesterol, HDL, LDHL, tryglicerides, ApoB) biomarkers will be quantified using fasting blood samples.
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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)
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Change in inflammatory biomarkers
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)
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Inflammatory (hsC-reactive protein, TNF-alpha, interleuken-6) biomarkers will be quantified using fasting blood samples.
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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)
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Change in aerobic capacity
Time Frame: Baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
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The Six-minute wheelchair propulsion test will be preformed with continuous expiratory gas analysis
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Baseline at the initiation of the walking program (T1), at the end of the walking program (T2)
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Collaborators and Investigators
Investigators
- Principal Investigator: Dany H. Gagnon, PT, PhD, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DG-SO-18A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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