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Spinal Cord InjuriesNCT03989752

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

A study testing Wearable Robotic Exoskeleton for Ambulation in people with Spinal Cord Injuries, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Wearable Robotic Exoskeleton for Ambulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteCanada
Study dates
14 Mar 2019to 7 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Montreal, Quebec, H2S 2J4

Other trials in Canada

About this study

Official title: Effects of an Overground Walking Program With Robotic Exoskeleton in Long-term Manual Wheelchair Users With a Chronic Spinal Cord Injury

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.

Read the 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.

Being tested
Wearable Robotic Exoskeleton for Ambulation
Keywords
Assistive Technology, Locomotion, Rehabilitation, Robotics
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wearable Robotic Exoskeleton for AmbulationDevice

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

Study groups in NCT03989752
Study groupRoleWhat they receive
Wearable robotic exoskeleton-assisted walking programExperimentalTotal 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).
Receives: Device: Wearable Robotic Exoskeleton for Ambulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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)

  2. Change in body composition

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

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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).

    Measured: 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)

  1. 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.

    Measured: 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)

  2. Change in glycemic biomarkers

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

    Measured: 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)

  3. Change in insulin resistance

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

    Measured: 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)

  4. Change in lipide profile

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

    Measured: 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)

  5. Change in inflammatory biomarkers

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

    Measured: 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)

  6. Change in aerobic capacity

    The Six-minute wheelchair propulsion test will be preformed with continuous expiratory gas analysis

    Measured: Baseline at the initiation of the walking program (T1), at the end of the walking program (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start14 Mar 2019
  3. Primary completion7 Jan 2022
  4. Study completion7 Jan 2022

Why it stopped: COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989752
Sponsor's protocol ID
DG-SO-18A
Status last verified
Sep 2023
First submitted
7 Jun 2019
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).

Publications

  • Vincent C, Dumont FS, Rogers M, Hu T, Bass A, Aubertin-Leheudre M, Karelis AD, Morin SN, McKerral M, Duclos C, Gagnon DH. Perspectives of wheelchair users with chronic spinal cord injury following a walking program using a wearable robotic exoskeleton. Disabil Rehabil. 2024 Dec;46(25):6204-6212. doi: 10.1080/09638288.2024.2317994. Epub 2024 Feb 15.

    PubMed 38357879

  • 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.

    PubMed 38163294

  • 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.

    PubMed 32663160

Questions about this trial

What is this clinical trial studying?

A study testing Wearable Robotic Exoskeleton for Ambulation in people with Spinal Cord Injuries, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: COVID-19). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989752, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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