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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05196204
Enrollment
45
Registered
2022-01-19
Start date
2021-05-11
Completion date
2022-10-31
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Trunk task-oriented training, Corticospinal tract, Functional electrical stimulation, Functional independence, Trunk motor control

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).

Interventions

OTHERTrunk-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.

OTHERTrunk-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.

Sponsors

Mitacs
CollaboratorINDUSTRY
Neuro-Concept Inc.
CollaboratorUNKNOWN
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Function in Sitting TestBefore and after the 12-week trainings and 1-month follow-upThis 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 TestBefore and after the 12-week trainings and every 4-weeks during the training periodThis test evaluates the ability for each participant to realize a lateral and anterior trunk flexion in order to observe the maximum distance reached.

Secondary

MeasureTime frameDescription
Change in EMG activation pattern of electromyographic activity of muscles in the trunkBefore and after the 12-week trainings and 1-month follow-upduring reaching and pointing tasks
Change in the center of pressure excursionBefore and after the 12-week trainings and 1-month follow-upduring reaching and pointing tasks
Modification of the excitability of the reticulospinal pathway using the acoustic startle responseBefore and after the 12-week trainings and 1-month follow-upA 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 stimulationBefore and after the 12-week trainings and 1-month follow-upVestibular responses induced by GVS will be identified in the trunk muscles

Other

MeasureTime frameDescription
Change in quality of life using World Health Organization Quality of Life with disabilities module (WHOQOL-BREF)Before and after the 12-week trainings and 1-month follow-upThis questionnaire consists in 39 questions about participant feelings.
Change in quality of life using Short-Form 36 questionnaireBefore and after the 12-week trainings and 1-month follow-upThe 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
Change in the Quality of life indexBefore and after the 12-week trainings and 1-month follow-upThis questionnaire consists in 37 questions about 4 domains: health and functioning, psychological/spiritual, social and economic, and family.
Change in functional independence using Spinal Cord Independence Measure questionnaireBefore and after the 12-week trainings and 1-month follow-upThis questionnaire consists in evaluation of self-care, respiration and sphincter management, and a participant's mobility abilities.
Physical Activity Recall Assessment for People with Spinal Cord Injury (questionnaire)Before and after the 12-week trainingsThis 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.

Countries

Canada

Contacts

Primary ContactDorothy Barthélemy, PhD, PT
dorothy.barthelemy@umontreal.ca514-343-7712
Backup ContactCharlotte Pion, PhD, Kin
charlotte.pion@umontreal.ca438-490-8512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026