Clinical trial NCT05200091: Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
Official title: Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Combined explosive strength and balance training
Balance control
Corticospinal tract
Intracortical mechanisms
Vestibular system
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: After obtaining their consent, participants will undertake evaluations at different times:

1. Assessment 1 week prior to training
2. Training over 4 weeks (nature of the training depends on the group)
3. Assessment 1 week after training
4. Assessment 1 month after training (follow-up)

Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:

* Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
* Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.

After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).

Eligibility criteria: FOR PARTICIPANTS WITH SPINAL CORD INJURY

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Exclusion Criteria:

* To have orthopedics problems
* To have cognitive deficits
* To have neurological problems

Primary outcomes:
measure: Change in muscles EMG responses following balance perturbation
timeFrame: Pre-intervention, immediately after and one-month after intervention
measure: Change in center of pressure displacement following balance perturbation using a force platform
timeFrame: Pre-intervention, immediately after and one-month after intervention
measure: Change in ankle muscle strength using force transducer
timeFrame: Pre-intervention, immediately after and one-month after intervention
Secondary outcomes:
measure: Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
timeFrame: Pre-intervention, immediately after and one-month after intervention
measure: Change in the influence of peripheral afferents on cortical output using short-afference inhibition
timeFrame: Pre-intervention, immediately after and one-month after intervention
measure: Change in the modulation of the H reflex by the corticospinal tract
timeFrame: Pre-intervention, immediately after and one-month after intervention
measure: Change in EMG responses following vestibular stimulations during quiet standing
timeFrame: Pre-intervention, immediately after and one-month after intervention
measure: Change in the excursion of the center of pressure following vestibular stimulations
timeFrame: Pre-intervention, immediately after and one-month after intervention
Other outcomes:
measure: MOntreal Cognitive Assessment (MoCA) score
timeFrame: Before enrollment
Locations:
city: Montréal
country: Canada
facility: Neuromobility lab
state: Quebec
Study officials:
References: