Recruiting

Task-oriented Training & Functional Electrical Stimulation

Sponsor:

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Code:

NCT05196204

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Trunk-oriented task training combined with functional electrical stimulation

Trunk-oriented task training alone

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05196204

Start date

May 11, 2021

Status verified date

Jan, 2022

Completion date

Oct, 2022

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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

Interventions

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.

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.

Primary outcome measure

  • Change in Function in Sitting Test [ Time Frame: Before and after the 12-week trainings and 1-month follow-up ]
  • Change in modified Functional Reach Test [ Time Frame: Before and after the 12-week trainings and every 4-weeks during the training period ]

Central Contacts and Locations

Central contacts

Dorothy Barthélemy, PhD, PT

514-343-7712dorothy.barthelemy@umontreal.ca

Charlotte Pion, PhD, Kin

438-490-8512charlotte.pion@umontreal.ca

Locations

Neuro-Concept Inc

Recruiting

Montreal, Quebec, Canada

Contacts

Charlotte Pion, PhD, Kin

438-490-8512charlotte.pion@umontreal.ca

More Information

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Last update posted

Jan 19, 2022

Last verified

Jan, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal on 2022-01-19.