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

Last updated: January 6, 2022
Sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT05196204
CRIR-1497-1020
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 45
Study Start date:
May 11, 2021
Estimated Completion Date:
October 31, 2022

Study 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).

Connect with a study center

  • Neuro-Concept Inc

    Montreal, Quebec
    Canada

    Active - Recruiting

  • Neuromobility lab

    Montréal, Quebec
    Canada

    Site Not Available

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