Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals with Traumatic SCI

University Health Network, Toronto

Status: Not yet enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: FES Therapy combined with task-specific training (FEST+TST)

Study type: Interventional

Funder types: Other

Identifiers

NCT04910204

19-6286

Details and patient eligibility

About

The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific training (FEST+TST) following spinal cord injury (SCI) influences functional and neurological recovery.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI

Exclusion criteria

• Contraindications for neurophysiological tests
• Contraindications for FEST
• Medical conditions that can limit treatment protocols
• Other neurological diseases (i.e. peripheral neuropathies)
• Significant persisting mental illness;
• Learning disabilities;
• Substance abuse over 6 months prior to recruitment;
• Hearing and visual deficits sufficient to affect test performance;
• Contraindication to MRI scanning

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Early FEST + TST

Experimental group

Description:

Participants will receive FEST+TST at 3 to 6 months from SCI onset.

Treatment:

Other: FES Therapy combined with task-specific training (FEST+TST)

Delayed FEST + TST

Experimental group

Description:

Participants will receive FEST+TST at 6 to 9 months from SCI onset.

Treatment:

Other: FES Therapy combined with task-specific training (FEST+TST)