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Exoskeleton

OLTP/PE + FES for Spinal Cord Injury

N/A

Waitlist Available

Led By François Routhier, PhD

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial aims to investigate the potential benefits of using robotic technologies and muscle stimulations to help with gait rehabilitation after a partial spinal cord injury.

Eligible Conditions

Incomplete Spinal Cord Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in 10 meter Walk Test (10mWT)

Change in Modified Six Minute Walk Test (6MWT)

Change in Modified Timed Up and Go test (TUG)

+1 more

Secondary outcome measures

Change in Brief pain inventory questionnaire

Spinal Cord

Electromyography

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: OLTP/PE+FESExperimental Treatment1 Intervention

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.

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Who is running the clinical trial?

Praxis Spinal Cord InstituteUNKNOWN

3 Previous Clinical Trials

60 Total Patients Enrolled

Laval UniversityLead Sponsor

417 Previous Clinical Trials

172,262 Total Patients Enrolled

François Routhier, PhDPrincipal InvestigatorLaval University

1 Previous Clinical Trials

54 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enrol in this research endeavor?

"This clinical trial is currently accepting 10 participants aged 18 to 70 with spinal cord injuries. Applicants must meet the following criteria: General, Measure between 1.5 and 1.9m tall; Weigh no more than 90kg; Have an incomplete spinal cord injury diagnosis; Possess a standing capacity at Stage 1B or higher according to Rick Hansen Institute SCI Standing and Walking Assessment Toolkit; Femur length of 37-49cm; Width of hips when seated below 42 cm ; Receive physician approval to take part in this project; Tolerance for standing greater than 15 minutes ; Sufficient upper body strength and dexterity to use a"

Answered by AI

Are those under the age of sixty admissible for this trial?

"This medical trial's eligibility requirements stipulate that patients must be aged 18 to 70. Those younger than 18 have 37 separate studies they could join, while those over 65 have 308 different options available."

Answered by AI

What are the key goals of this research?

"This trial, which will be evaluated at baseline and after the intervention period (1-2 weeks), aims to measure changes in subject's 10mWT. Secondary metrics include alterations to SCI-SCS scores on a 4 point ordinal scale ranging from 0-3; MAS measurements of lower limb spasticity with a range of 0-4; as well as modifications observed in participants' pain intensity ratings gathered through the BPI questionnaire."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

François Routhier 2020. "Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04568928.