Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries | Device: Wearable Robotic Exoskeleton for Ambulation | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Effects of an Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With a Chronic Spinal Cord Injury |
Actual Study Start Date : | March 14, 2019 |
Estimated Primary Completion Date : | December 14, 2021 |
Estimated Study Completion Date : | April 14, 2022 |
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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Device: Wearable Robotic Exoskeleton for Ambulation
16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exoskeleton-specific inclusion criteria:
Exclusion Criteria:
Exoskeleton-specific exclusion criteria:
Canada, Quebec | |
Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM) | |
Montréal, Quebec, Canada, H2S 2J4 |
Principal Investigator: | Dany H. Gagnon, PT, PhD | Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | June 7, 2019 | ||||||||||||||||
First Posted Date ICMJE | June 18, 2019 | ||||||||||||||||
Last Update Posted Date | August 6, 2020 | ||||||||||||||||
Actual Study Start Date ICMJE | March 14, 2019 | ||||||||||||||||
Estimated Primary Completion Date | December 14, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury | ||||||||||||||||
Official Title ICMJE | Effects of an Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With a Chronic Spinal Cord Injury | ||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Spinal Cord Injuries | ||||||||||||||||
Intervention ICMJE | Device: Wearable Robotic Exoskeleton for Ambulation
16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist
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Study Arms ICMJE | 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).
Intervention: Device: Wearable Robotic Exoskeleton for Ambulation
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Publications * | 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. | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Suspended | ||||||||||||||||
Estimated Enrollment ICMJE |
20 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | April 14, 2022 | ||||||||||||||||
Estimated Primary Completion Date | December 14, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exoskeleton-specific inclusion criteria:
Exclusion Criteria:
Exoskeleton-specific exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Canada | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT03989752 | ||||||||||||||||
Other Study ID Numbers ICMJE | DG-SO-18A | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dany H. Gagnon, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal | ||||||||||||||||
Study Sponsor ICMJE | Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal | ||||||||||||||||
Verification Date | August 2020 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |