NCT05196204

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

September 1, 2021

Last Update Submit

January 6, 2022

Conditions

Spinal Cord Injuries

Keywords

Trunk task-oriented trainingCorticospinal tractFunctional electrical stimulationFunctional independenceTrunk motor control

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in EMG activation pattern of electromyographic activity of muscles in the trunk

    Before and after the 12-week trainings and 1-month follow-up

  • Change in the center of pressure excursion

    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

    Before and after the 12-week trainings and 1-month follow-up

  • Modification of the excitability of the vestibulospinal pathway using galvanic vestibular stimulation

    Before and after the 12-week trainings and 1-month follow-up

Other Outcomes (5)

  • Physical Activity Recall Assessment for People with Spinal Cord Injury (questionnaire)

    Before and after the 12-week trainings

  • 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-up

  • Change in quality of life using Short-Form 36 questionnaire

    Before and after the 12-week trainings and 1-month follow-up

  • +2 more other outcomes

Study Arms (3)

Trunk-oriented task combined with functional electrical stimulation training group

EXPERIMENTAL

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

Trunk-oriented task training group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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 stimulationOTHER

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 combined with functional electrical stimulation training group
Trunk-oriented task training aloneOTHER

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.

Trunk-oriented task training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • To have orthopedics problems
  • To have cognitive deficits
  • To have neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Neuro-Concept Inc

Montreal, Quebec, Canada

RECRUITING

Neuromobility lab

Montreal, Quebec, Canada

ENROLLING BY INVITATION

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Dorothy Barthélemy, PhD, PT

CONTACT

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

Charlotte Pion, PhD, Kin

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor and researcher

Study Record Dates

First Submitted

September 1, 2021

First Posted

January 19, 2022

Study Start

May 11, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations

CA(2)