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

NCT03989752 | Terminated DMC

• 1 other identifier: DG-SO-18A
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Assistive Technology; Locomotion; Rehabilitation; Robotics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change in bone turnover biomarkers

  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

  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

  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

  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

  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)

Study Arms (1)

Wearable robotic exoskeleton-assisted walking program

EXPERIMENTAL

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

Interventions

Wearable Robotic Exoskeleton for Ambulation DEVICE

16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist

Wearable robotic exoskeleton-assisted walking program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead
• Université de Montréal: collaborator
• Université du Québec a Montréal: collaborator

Study Sites (1)

Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)

Montreal, Quebec, H2S 2J4, Canada

Location

Related Publications (2)

• Bass A, Morin SN, Guidea M, Lam JTAT, Karelis AD, Aubertin-Leheudre M, Gagnon DH; Montreal Exoskeleton Walking Program (MEWP) Group. Potential Effects of an Exoskeleton-Assisted Overground Walking Program for Individuals With Spinal Cord Injury Who Uses a Wheelchair on Imaging and Serum Markers of Bone Strength: Pre-Post Study. JMIR Rehabil Assist Technol. 2024 Jan 1;11:e53084. doi: 10.2196/53084.

  PMID: 38163294 DERIVED

• 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.

  PMID: 32663160 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dany H. Gagnon, PT, PhD

  Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 18, 2019
• Study Start: March 14, 2019
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

CA (1)