- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04568928
Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Quebec City, Quebec, Canada
- Laval University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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).
Exclusion Criteria:
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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: OLTP/PE+FES
3-5 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. |
12 sessions OLTP/PE + FES
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
A walking endurance test that measures the longest distance covered continuously during a maximum of six minutes.
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Change in 10 meter Walk Test (10mWT)
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Measures preferred and maximal walking speeds over 10 meters
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Change in Modified Timed Up and Go test (TUG)
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
A functional test that assesses sit-to-stand transfers, balance and mobility
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Change in Walking Index for Spinal Cord Injury (WISCI-II)
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
functional walking capacity scale that describes the amount of physical assistance, braces or devices required to walk 10 meters
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Brief pain inventory questionnaire
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Intensity of pain
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS)
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
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
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Change in the Modified Ashworth Scale (MAS)
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
A measure of lower limb spasticity. Scores range from 0 to 4. Higher scores indicate greater spasticity. scale. |
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system.
Time Frame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
|
Muscle activation patterns (i.e., amplitude, timing) and muscle fatigue (reduction in the median frequency of the EMG power spectrum) will be documented.
|
2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-2002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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