4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With Spinal Cord Injury

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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Wearable Robotic Exoskeleton for Ambulation Not Applicable

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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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).
Device: Wearable Robotic Exoskeleton for Ambulation
16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist

Outcome Measures
Primary Outcome Measures :
  1. 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) ]
    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).

  2. 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) ]
    DXA scans will be used to quantify total and regional body fat and fat free tissue mass (and relative percentages).

  3. 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) ]
    Cross-sectional images of the radius, tibia and femur captured with pQCT will be used to measure muscle cross-sectional area.

  4. 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) ]
    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 :
  1. 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) ]
    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.

  2. 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) ]
    Glycemic (i.e., fasting glucose, insulin, glycosylated hemoglobin (Hb A1C)) biomarkers will be quantified using fasting blood samples.

  3. 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) ]
    Insulin resistance (hemeostatic model assessment (HOMA-1R)) will be quantified using fasting blood samples.

  4. 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) ]
    Lipid (i.e. Total cholesterol, HDL, LDHL, tryglicerides, ApoB) biomarkers will be quantified using fasting blood samples.

  5. 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) ]
    Inflammatory (hsC-reactive protein, TNF-alpha, interleuken-6) biomarkers will be quantified using fasting blood samples.

  6. Change in aerobic capacity [ Time Frame: Baseline at the initiation of the walking program (T1), at the end of the walking program (T2) ]
    The Six-minute wheelchair propulsion test will be preformed with continuous expiratory gas analysis


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Canada, Quebec
Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
Montréal, Quebec, Canada, H2S 2J4
Sponsors and Collaborators
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Université de Montréal
Université du Québec a Montréal
Investigators
Layout table for investigator information
Principal Investigator: Dany H. Gagnon, PT, PhD Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Tracking Information
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
 (submitted: June 17, 2019)
  • 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) ]
    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 [ 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) ]
    DXA scans will be used to quantify total and regional body fat and fat free tissue mass (and relative percentages).
  • 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) ]
    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 [ 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) ]
    Cross-sectional images of the radius, tibia and femur captured with pQCT will be used to measure intramuscular fat infiltration (i.e., muscle density).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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) ]
    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 [ 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) ]
    Glycemic (i.e., fasting glucose, insulin, glycosylated hemoglobin (Hb A1C)) biomarkers will be quantified using fasting blood samples.
  • 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) ]
    Insulin resistance (hemeostatic model assessment (HOMA-1R)) will be quantified using fasting blood samples.
  • 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) ]
    Lipid (i.e. Total cholesterol, HDL, LDHL, tryglicerides, ApoB) biomarkers will be quantified using fasting blood samples.
  • 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) ]
    Inflammatory (hsC-reactive protein, TNF-alpha, interleuken-6) biomarkers will be quantified using fasting blood samples.
  • Change in aerobic capacity [ Time Frame: Baseline at the initiation of the walking program (T1), at the end of the walking program (T2) ]
    The Six-minute wheelchair propulsion test will be preformed with continuous expiratory gas analysis
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.

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
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
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
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.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 5 years following article publication
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
URL: http://crir.ca
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
  • Université de Montréal
  • Université du Québec a Montréal
Investigators  ICMJE
Principal Investigator: Dany H. Gagnon, PT, PhD Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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