Clinical trial NCT05196204: Trunk Task-oriented Training Combined With Functional Electrical Stimulation in Spinal Cord Injured Individuals
Official title: Trunk Task-oriented Training Combined With Functional Electrical Stimulation to Improve Functional Independence, Postural Control and Neuroplasticity in Spinal Cord Injured Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Trunk task-oriented training
Corticospinal tract
Functional electrical stimulation
Functional independence
Trunk motor control
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Neuro-Concept Inc.
First posted: 2022-01-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (FES/T-TOT) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following FES/T-TOT in individuals with spinal cord injury.

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

1. Assessment 3 weeks prior to training
2. Assessment 1 week prior to training
3. Training over 12 weeks
4. Assessment 1 week after training
5. 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. The assessment will consist of:

* Session 1 (at Neuro-Concept clinic) will include presentation of the study and the obtention of written consent, clinical (modified Reaching test and muscle strength), quality of life and functional independence assessments.
* Session 2 (at IURDPM in Dr. Barthélemy's laboratory) will include postural control, corticospinal and cortical assessments.

After the initial assessment, the participants with spinal cord injury will realize 36 sessions of trunk task-oriented training alone or combined with function electrical stimulation (3 times a week for 12 weeks).

Eligibility criteria: FOR PARTICIPANTS WITH SPINAL CORD INJURY

Inclusion Criteria:

* Level of spinal cord lesion between C6/C7 and T10
* At least, 6 months post-injury
* Be considered as AIS A, B, C or D
* Be able to sit without support for 15 seconds
* Be able to provide informed consent in English or in French

Exclusion Criteria:

* To have cognitive deficits
* To wear a corset
* 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 Function in Sitting Test
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Change in modified Functional Reach Test
timeFrame: Before and after the 12-week trainings and every 4-weeks during the training period
Secondary outcomes:
measure: Change in EMG activation pattern of electromyographic activity of muscles in the trunk
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Change in the center of pressure excursion
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Modification of the excitability of the reticulospinal pathway using the acoustic startle response
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation
timeFrame: Before and after the 12-week trainings and 1-month follow-up
Other outcomes:
measure: Physical Activity Recall Assessment for People with Spinal Cord Injury (questionnaire)
timeFrame: Before and after the 12-week trainings
measure: Change in quality of life using World Health Organization Quality of Life with disabilities module (WHOQOL-BREF)
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Change in quality of life using Short-Form 36 questionnaire
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Change in the Quality of life index
timeFrame: Before and after the 12-week trainings and 1-month follow-up
measure: Change in functional independence using Spinal Cord Independence Measure questionnaire
timeFrame: Before and after the 12-week trainings and 1-month follow-up
Locations:
city: Montreal
country: Canada
facility: Neuro-Concept Inc
state: Quebec
city: Montréal
country: Canada
facility: Neuromobility lab
state: Quebec
Study officials:
References: