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

NCT ID: NCT04910204

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Keywords

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functional electrical stimulation task-specific training upper limb rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early FEST + TST

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

The FEST+TST protocol consists of a 1-hour session, 3 to 5 days a week, for up to 12 weeks (40 sessions total) in addition to conventional occupational and physical therapies according to the standard of care.

Delayed FEST + TST

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

The FEST+TST protocol consists of a 1-hour session, 3 to 5 days a week, for up to 12 weeks (40 sessions total) in addition to conventional occupational and physical therapies according to the standard of care.

Interventions

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

The FEST+TST protocol consists of a 1-hour session, 3 to 5 days a week, for up to 12 weeks (40 sessions total) in addition to conventional occupational and physical therapies according to the standard of care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Julio Furlan, MD

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julio Furlan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KITE, Toronto Rehab-University Health Network

Locations

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Lyndhurst Centre, KITE - TRI UHN

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Lamisa Etu, BSc

Role: CONTACT

Phone: 4165973422

Email: [email protected]

Other Identifiers

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19-6286

Identifier Type: -

Identifier Source: org_study_id