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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Trunk-oriented task training combined with functional electrical stimulation; Other: Trunk-oriented task training alone

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).

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorothy Barthélemy, PhD, PT; Phone Number: 514-343-7712; Email: dorothy.barthelemy@umontreal.ca
• Study Contact Backup: Name: Charlotte Pion, PhD, Kin; Phone Number: 438-490-8512; Email: charlotte.pion@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Recruiting
      • Neuro-Concept Inc
      • Contact: Charlotte Pion, PhD, Kin; Phone Number: 438-490-8512; Email: charlotte.pion@umontreal.ca
    • Montréal, Quebec, Canada
      • Enrolling by invitation
      • Neuromobility lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trunk-oriented task combined with functional electrical stimulation training group; 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; 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.
Active Comparator: Trunk-oriented task training group; 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; 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.
No Intervention: Control group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Recall Assessment for People with Spinal Cord Injury (questionnaire)	This interview will capture all physical activity information over the previous 3 days. Eight periods of day will be screened (morning routine, breakfast, morning, lunch, afternoon, dinner, evening, evening routine). This test allows us to verify if the intensity of daily physical activity of each participant will be constant during the intervention.	Before and after the 12-week trainings
Change in quality of life using World Health Organization Quality of Life with disabilities module (WHOQOL-BREF)	This questionnaire consists in 39 questions about participant feelings.	Before and after the 12-week trainings and 1-month follow-up
Change in quality of life using Short-Form 36 questionnaire	The questionnaire consists in 36 questions about 8 domains: physical functioning, role functioning-physical, bodily pain, general health, vitality, social functioning, role functioning-emotional and mental health	Before and after the 12-week trainings and 1-month follow-up
Change in the Quality of life index	This questionnaire consists in 37 questions about 4 domains: health and functioning, psychological/spiritual, social and economic, and family.	Before and after the 12-week trainings and 1-month follow-up
Change in functional independence using Spinal Cord Independence Measure questionnaire	This questionnaire consists in evaluation of self-care, respiration and sphincter management, and a participant's mobility abilities.	Before and after the 12-week trainings and 1-month follow-up

Collaborators and Investigators

• Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
• Collaborators: Mitacs; Neuro-Concept Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Corticospinal tract; Trunk task-oriented training; Functional electrical stimulation; Functional independence; Trunk motor control
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: CRIR-1497-1020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No