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

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Status: Unknown

Conditions: Spinal Cord Injuries

Treatments: Other: Trunk-oriented task training alone; Other: Trunk-oriented task training combined with functional electrical stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05196204

CRIR-1497-1020

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Trunk-oriented task combined with functional electrical stimulation training group

Experimental group

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.

Treatment:

Other: Trunk-oriented task training combined with functional electrical stimulation

Trunk-oriented task training group

Active Comparator group

Description:

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

Treatment:

Other: Trunk-oriented task training alone

Control group

No Intervention group

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