Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
1 other identifier
interventional
36
1 country
1
Brief Summary
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2018
CompletedFirst Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 20, 2022
January 1, 2022
4.4 years
September 1, 2021
January 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in muscles EMG responses following balance perturbation
Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
Pre-intervention, immediately after and one-month after intervention
Change in center of pressure displacement following balance perturbation using a force platform
Excursion of centre of pressure will be analyzed following forward and backward perturbation.
Pre-intervention, immediately after and one-month after intervention
Change in ankle muscle strength using force transducer
Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
Pre-intervention, immediately after and one-month after intervention
Secondary Outcomes (5)
Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
Pre-intervention, immediately after and one-month after intervention
Change in the influence of peripheral afferents on cortical output using short-afference inhibition
Pre-intervention, immediately after and one-month after intervention
Change in the modulation of the H reflex by the corticospinal tract
Pre-intervention, immediately after and one-month after intervention
Change in EMG responses following vestibular stimulations during quiet standing
Pre-intervention, immediately after and one-month after intervention
Change in the excursion of the center of pressure following vestibular stimulations
Pre-intervention, immediately after and one-month after intervention
Other Outcomes (1)
MOntreal Cognitive Assessment (MoCA) score
Before enrollment
Study Arms (3)
Combined explosive strength and specific balance training group
EXPERIMENTALThis group will be formed with participants with incomplete spinal cord injury. This group will perform 4 weeks of combined explosive strength and specific balance training.
Spinal cord injury control group
NO INTERVENTIONThis group will be formed with participants with incomplete spinal cord injury. They will perform all the evaluation before and after a 4-week period of rest (no training).
Healthy control group
NO INTERVENTIONHealthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.
Interventions
Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations. Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements. Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions: * Forward tilt of base of support; * Backward tilt of base of support; * Translation forward; * Translation backward; * Without moving their feet, participants will have to move their avatar to reach different targets placed around them on the screen, at different distance from the center.
Eligibility Criteria
You may qualify if:
- Have an incomplete lesion of spinal cord
- Level of spinal cord lesion between C5 and T12
- At least, 6 months post-injury
- Be considered as AIS C or D
- Be able to stand without support for 15 seconds
- Be able to provide informed consent in English or in French
You may not qualify if:
- To have cognitive deficits
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
- FOR CONTROL PARTICIPANTS
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neuromobility lab
Montreal, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor and researcher
Study Record Dates
First Submitted
September 1, 2021
First Posted
January 20, 2022
Study Start
July 9, 2018
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 20, 2022
Record last verified: 2022-01