Trunk Task-oriented Training Combined With Functional Electrical Stimulation in Spinal Cord Injured Individuals

Study Overview
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Brief Summary
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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
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After obtaining their consent, participants will undertake evaluations at different times: Assessment 3 weeks prior to training Assessment 1 week prior to training Training over 12 weeks Assessment 1 week after training 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).

Official Title
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Trunk Task-oriented Training Combined With Functional Electrical Stimulation to Improve Functional Independence, Postural Control and Neuroplasticity in Spinal Cord Injured Individuals

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Trunk-oriented task training combined with functional electrical stimulation
* Other: Trunk-oriented task training alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trunk-oriented task combined with functional electrical stimulation training group<br>This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training combined with functional electrical stimulation. | Other: Trunk-oriented task training combined with functional electrical stimulation<br>* Training will consist to perform one hour of trunk task-oriented training combined with functional electrical stimulation (FES/T-TOT) specific for muscle strength and motor control. All training will be done seated without support with knees and hips flexed to 90 degrees. FES will be combined with functional and non-functional tasks to work functionality and muscle strengthening. Each training session will consist on the fulfilment of two functional tasks (as reaching) and two non-functional tasks (as push-up movement) from a battery of postural control exercises.<br>|
| Active Comparator: Trunk-oriented task training group<br>This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training. | Other: Trunk-oriented task training alone<br>* The SCI participants who will perform T-TOT training alone will have to perform the same exercises as explained in the previous section (two functional tasks and two non-functional tasks) but they will not receive any functional electrical stimulation. Training will consist to perform one hour of trunk task-oriented training (T-TOT) specific for muscle strength and motor control. All training will be done seated without support with knees and hips flexed to 90 degrees. Each training session will consist on the fulfilment of two functional tasks (as reaching) and two non-functional tasks (as push-up movement) from a battery of postural control exercises.<br>|
| No Intervention: Control group<br>Healthy participants will be recruited based on the age and sex of the participants with spinal cord injury to realize clinical, biomechanical and cortical evaluations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Function in Sitting Test | This test evaluates the sitting balance via 14 everyday functional activities rated from 0 to 4 according to the reactions of the participants. | Before and after the 12-week trainings and 1-month follow-up | 
| Change in modified Functional Reach Test | This test evaluates the ability for each participant to realize a lateral and anterior trunk flexion in order to observe the maximum distance reached. | Before and after the 12-week trainings and every 4-weeks during the training period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EMG activation pattern of electromyographic activity of muscles in the trunk | during reaching and pointing tasks | Before and after the 12-week trainings and 1-month follow-up | 
| Change in the center of pressure excursion | during reaching and pointing tasks | Before and after the 12-week trainings and 1-month follow-up | 
| Modification of the excitability of the reticulospinal pathway using the acoustic startle response | A tone will be triggered just before the reaching movement. The EMG responses of trunk muscles will be analyzed. | Before and after the 12-week trainings and 1-month follow-up | 
| Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation | Vestibular responses induced by GVS will be identified in the trunk muscles | Before and after the 12-week trainings and 1-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trunk task-oriented training, Corticospinal tract, Functional electrical stimulation, Functional independence, Trunk motor control