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

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Trunk-oriented task training combined with functional electrical stimulation
Trunk-oriented task training alone
Sponsored by
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Trunk task-oriented training, Corticospinal tract, Functional electrical stimulation, Functional independence, Trunk motor control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Neuro-Concept IncRecruiting
  • Neuromobility lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Trunk-oriented task combined with functional electrical stimulation training group

Trunk-oriented task training group

Control group

Arm Description

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.

This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in EMG activation pattern of electromyographic activity of muscles in the trunk
during reaching and pointing tasks
Change in the center of pressure excursion
during reaching and pointing tasks
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.
Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation
Vestibular responses induced by GVS will be identified in the trunk muscles

Full Information

First Posted
September 1, 2021
Last Updated
January 6, 2022
Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Collaborators
Mitacs, Neuro-Concept Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05196204
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Collaborators
Mitacs, Neuro-Concept Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Trunk task-oriented training, Corticospinal tract, Functional electrical stimulation, Functional independence, Trunk motor control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trunk-oriented task combined with functional electrical stimulation training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Trunk-oriented task training group
Arm Type
Active Comparator
Arm Description
This group will be formed with participants with spinal cord injury. This group will perform 12 weeks of trunk-oriented task training.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Trunk-oriented task training combined with functional electrical stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Trunk-oriented task training alone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Function in Sitting Test
Description
This test evaluates the sitting balance via 14 everyday functional activities rated from 0 to 4 according to the reactions of the participants.
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Change in modified Functional Reach Test
Description
This test evaluates the ability for each participant to realize a lateral and anterior trunk flexion in order to observe the maximum distance reached.
Time Frame
Before and after the 12-week trainings and every 4-weeks during the training period
Secondary Outcome Measure Information:
Title
Change in EMG activation pattern of electromyographic activity of muscles in the trunk
Description
during reaching and pointing tasks
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Change in the center of pressure excursion
Description
during reaching and pointing tasks
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Modification of the excitability of the reticulospinal pathway using the acoustic startle response
Description
A tone will be triggered just before the reaching movement. The EMG responses of trunk muscles will be analyzed.
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation
Description
Vestibular responses induced by GVS will be identified in the trunk muscles
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Other Pre-specified Outcome Measures:
Title
Physical Activity Recall Assessment for People with Spinal Cord Injury (questionnaire)
Description
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.
Time Frame
Before and after the 12-week trainings
Title
Change in quality of life using World Health Organization Quality of Life with disabilities module (WHOQOL-BREF)
Description
This questionnaire consists in 39 questions about participant feelings.
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Change in quality of life using Short-Form 36 questionnaire
Description
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
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Change in the Quality of life index
Description
This questionnaire consists in 37 questions about 4 domains: health and functioning, psychological/spiritual, social and economic, and family.
Time Frame
Before and after the 12-week trainings and 1-month follow-up
Title
Change in functional independence using Spinal Cord Independence Measure questionnaire
Description
This questionnaire consists in evaluation of self-care, respiration and sphincter management, and a participant's mobility abilities.
Time Frame
Before and after the 12-week trainings and 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorothy Barthélemy, PhD, PT
Phone
514-343-7712
Email
dorothy.barthelemy@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Pion, PhD, Kin
Phone
438-490-8512
Email
charlotte.pion@umontreal.ca
Facility Information:
Facility Name
Neuro-Concept Inc
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Pion, PhD, Kin
Phone
438-490-8512
Email
charlotte.pion@umontreal.ca
Facility Name
Neuromobility lab
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

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

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