Last updated: August 22, 2022
Sponsor: Laval University
Overall Status: Active - Enrolling
Phase
N/A
Condition
Spinal Cord Injuries
Treatment
N/AClinical Study ID
NCT04568928
2020-2002
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 walkingability at Stage 1B or more of the Rick Hansen Institute SCI Standing and WalkingAssessment 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 lowerextremity muscle groups: (gluteus, quadriceps, hamstrings, dorsiflexors, etc.) asdetermined by a physiotherapist.
- Have no contraindications to FES according to the guidelines of the Canadianphysiotherapy association (CPA).
Exclusion
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 thecompany
- Present lower extremity skin lesions or sores
- Any medical condition or co-morbidity that may impair collaboration and participationor 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 Design
Total Participants: 10
Study Start date:
December 10, 2020
Estimated Completion Date:
August 31, 2023
Study Description
Connect with a study center
Laval University
Quebec City, Quebec
CanadaSite Not Available
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