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

NCT ID: NCT03989752

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2022-01-07

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Wearable Robotic Exoskeleton for Ambulation

Intervention Type: DEVICE

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

Interventions

Wearable Robotic Exoskeleton for Ambulation

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

Intervention Type: DEVICE

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

Université du Québec a Montréal

OTHER

Sponsor Role: collaborator

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

OTHER

Sponsor Role: lead

Responsible Party

Dany H. Gagnon

Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dany H. Gagnon, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Locations

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

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38163294 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32663160 (View on PubMed)

Other Identifiers

DG-SO-18A

Identifier Type: -

Identifier Source: org_study_id