Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wearable Robotic Exoskeleton for Ambulation
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Assistive Technology, Locomotion, Rehabilitation, Robotics
Eligibility Criteria
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
Sites / Locations
- Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wearable robotic exoskeleton-assisted walking program
Arm Description
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).
Outcomes
Primary Outcome Measures
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).
Change in body composition
DXA scans will be used to quantify total and regional body fat and fat free tissue mass (and relative percentages).
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.
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).
Secondary Outcome Measures
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.
Change in glycemic biomarkers
Glycemic (i.e., fasting glucose, insulin, glycosylated hemoglobin (Hb A1C)) biomarkers will be quantified using fasting blood samples.
Change in insulin resistance
Insulin resistance (hemeostatic model assessment (HOMA-1R)) will be quantified using fasting blood samples.
Change in lipide profile
Lipid (i.e. Total cholesterol, HDL, LDHL, tryglicerides, ApoB) biomarkers will be quantified using fasting blood samples.
Change in inflammatory biomarkers
Inflammatory (hsC-reactive protein, TNF-alpha, interleuken-6) biomarkers will be quantified using fasting blood samples.
Change in aerobic capacity
The Six-minute wheelchair propulsion test will be preformed with continuous expiratory gas analysis
Full Information
NCT ID
NCT03989752
First Posted
June 7, 2019
Last Updated
September 6, 2023
Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Collaborators
Université de Montréal, Université du Québec a Montréal
1. Study Identification
Unique Protocol Identification Number
NCT03989752
Brief Title
Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury
Official Title
Effects of an Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With a Chronic Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
January 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Collaborators
Université de Montréal, Université du Québec a Montréal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Assistive Technology, Locomotion, Rehabilitation, Robotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wearable robotic exoskeleton-assisted walking program
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Wearable Robotic Exoskeleton for Ambulation
Intervention Description
16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist
Primary Outcome Measure Information:
Title
Change in bone mass density (BMD) and architecture in the lower extremity
Description
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)
Title
Change in body composition
Description
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)
Title
Change in muscle size
Description
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)
Title
Change in intramuscular fat infiltration
Description
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)
Secondary Outcome Measure Information:
Title
Change in bone turnover biomarkers
Description
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)
Title
Change in glycemic biomarkers
Description
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)
Title
Change in insulin resistance
Description
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)
Title
Change in lipide profile
Description
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)
Title
Change in inflammatory biomarkers
Description
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)
Title
Change in aerobic capacity
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dany H. Gagnon, PT, PhD
Organizational Affiliation
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2S 2J4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
IPD Sharing URL
http://crir.ca
Citations:
PubMed Identifier
32663160
Citation
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.
Results Reference
derived
Learn more about this trial
Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury
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