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Incomplete Spinal Cord InjuryNCT04568928

Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

A study testing OLTP/PE + FES in people with Incomplete Spinal Cord Injury, run by Laval University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

After partial spinal cord injury, gait deficits may be present and often remain even after intensive rehabilitation. New robotic technologies have recently emerged to help augment the extent of rehabilitation. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Incomplete Spinal Cord Injury
What is being tested?
OLTP/PE + FES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
10 Dec 2020to Aug 2023
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General
  • Measure between 5'1" and 6'3" (1.5 and 1.9m)
  • Weigh less than 200 pounds (90kg)
  • Present a diagnosis of incomplete spinal cord injury
  • Have the ability to maintain a standing position and/or have therapeutic walking ability at Stage 1B or more of the Rick Hansen Institute SCI Standing and Walking Assessment Toolkit
  • Present sufficient upper extremity strength and function to use a walker with wheels
Show all 13Show fewer
  • Femur length between 37 and 49cm
  • Width of hips when seated <42 cm
  • Obtain approval from a physician to participate in the project
  • Standing tolerance >15 minutes
  • For FES:
  • Respond favourably to functional electrical stimulation (FES) of the main lower extremity muscle groups: (gluteus, quadriceps, hamstrings, dorsiflexors, etc.) as determined by a physiotherapist.
  • Have no contraindications to FES according to the guidelines of the Canadian physiotherapy association (CPA).

Who cannot join

  • General:
  • Poor fit of the exoskeleton as determined by the research team
  • Present contraindications to the use of the Indego® exoskeleton as described by the company
  • Present lower extremity skin lesions or sores
  • Any medical condition or co-morbidity that may impair collaboration and participation or making it unsafe to wear the exoskeleton, for example (non-exhaustive list) :
  • Disabling pain.
Show all 24Show fewer
  • Significant sensory disturbances in the lower limbs that limit safe walking.
  • Cognitive disorders that impair the ability to collaborate.
  • Osteoporosis.
  • Unconsolidated fractures of the lower limbs.
  • Uncontrolled reflex dysautonomia.
  • Severe peripheral vascular disease.
  • Severe heart failure.
  • Severe, active infection
  • FES Exclusion Criteria
  • Pregnancy;
  • Presence of a malignant tumor
  • Deep vein thrombosis
  • Hemorrhagic condition
  • Infection or osteomyelitis
  • Presence of weakened/damaged skin
  • Circulatory disorders
  • Epilepsy
  • Electronic implant

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Laval University

    Québec, Quebec

Other trials in Canada

About this study

Official title: Implementation of Locomotor Training Program Using a Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice for Persons With an Incomplete Spinal Cord Injury - WHY and HOW to do it?

After partial spinal cord injury, gait deficits may be present and often remain even after intensive rehabilitation. New robotic technologies have recently emerged to help augment the extent of rehabilitation. However, these are complex tools to integrate into clinical practice and little is known about the potential factors that may influence the uptake of a locomotor program using this technology by clinicians. The goal of this project is to bring together researchers, administrators, clinicians and patients to define and implement an overground robotized gait training program in clinic. We will also investigate the added value of leg and trunk muscle stimulation combined with robotic walking training, to see if it could enhance recovery.

Read the detailed description

Powered exoskeleton technology represents a promising rehabilitation intervention for persons with incomplete spinal cord injury (iSCI). The overall aim of the present study is to investigate the implementability of an overground locomotor training program using a powered exoskeleton in persons with a subacute iSCI at the Institut de réadaptation en déficience physique de Québec, with and without functional electrical stimulation (FES). Over the 2-year period of the project, a logic model will be co-developed with stakeholders to support clinicians and administrators in the management of the locomotor training program. Using qualitative and quantitative research methods, we will evaluate the feasibility and perceived barriers/facilitators to the implementation in clinical practice of the training program. Finally, a pre-post design with individuals receiving the intervention either combined with FES or not, will allow quantifying of the benefits of combining FES in addition to robotic gait training on functional walking capacity in persons with a subacute iSCI.

Being tested
OLTP/PE + FES
Keywords
Exoskeleton, locomotor training, FES, SCI

What participants receive

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

  • OLTP/PE + FESDevice

    12 sessions OLTP/PE + FES

Study groups in NCT04568928
Study groupRoleWhat they receive
OLTP/PE+FESExperimental3-5 familiarization sessions + 12 training sessions (3 blocks of 4 training sessions; 60-90 min each session, 2-3 sessions per week) of an overground locomotor training program using a powered exoskeleton combined with functional electrical stimulation (OLTP/PE+FES). The training sessions are divided into 3 blocks. Each block will take place over a period of approximately 2 weeks (2-3 sessions/week) and will consist of 3 training sessions with exoskeleton combined with FES and a fourth session with exoskeleton alone, without FES. For each participant, FES intensity will be set for each muscle in order to elicit a palpable muscle contraction. FES timing and duration is already built into the device. For each participant, specific level of assistance for each hip and knee, and gait parameters will be set and adjusted during a familiarization period with the PE. Level of PE assistance will then be adjusted weekly to ensure training progression.
Receives: Device: OLTP/PE + FES

What is being measured

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

  1. Change in Modified Six Minute Walk Test (6MWT)

    A walking endurance test that measures the longest distance covered continuously during a maximum of six minutes.

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

  2. Change in 10 meter Walk Test (10mWT)

    Measures preferred and maximal walking speeds over 10 meters

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

  3. Change in Modified Timed Up and Go test (TUG)

    A functional test that assesses sit-to-stand transfers, balance and mobility

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

  4. Change in Walking Index for Spinal Cord Injury (WISCI-II)

    functional walking capacity scale that describes the amount of physical assistance, braces or devices required to walk 10 meters

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Secondary outcomes (4)

  1. Change in Brief pain inventory questionnaire

    Intensity of pain

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

  2. Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS)

    This scale specifically targets secondary conditions associated with SCI that directly and indirectly impact health and physical functioning. The rating scale uses a 4-point ordinal scale ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem). Total scores range from 0 to 48. Higher scores indicate greater overall problems with secondary conditions

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

  3. Change in the Modified Ashworth Scale (MAS)

    A measure of lower limb spasticity. Scores range from 0 to 4. Higher scores indicate greater spasticity.

    scale.

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

  4. Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system.

    Muscle activation patterns (i.e., amplitude, timing) and muscle fatigue (reduction in the median frequency of the EMG power spectrum) will be documented.

    Measured: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Timeline

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

  1. First posted29 Sep 2020
  2. Study start10 Dec 2020
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 2023 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568928
Sponsor's protocol ID
2020-2002
Status last verified
Aug 2022
First submitted
11 Sep 2020
Last updated
24 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing OLTP/PE + FES in people with Incomplete Spinal Cord Injury, run by Laval University 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 13 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. 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?

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 Modified Six Minute Walk Test (6MWT) (time frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)). 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 NCT04568928.

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 24 Aug 2022.

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