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

NCT04910204 | Not Yet Recruiting

• 1 other identifier: 19-6286
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

functional electrical stimulation; task-specific training; upper limb rehabilitation

Outcome Measures

Primary Outcomes (4)

• Spinal Cord Independence Measure (SCIM)

  Self-care SCIM subscore (0-20) and total SCIM score (0-100) will be used to assess the degree of disability for individuals with SCI with respect to activities of daily living; higher scores reflect greater degree of functional independence

  Change from baseline SCIM at 3 & 6 months

• American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS)

  International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.

  Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])

• ASIA Upper-Extremity Sensory Score (UESS)

  International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.

  Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])

• Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)

  The GRASSP is a clinical measure used to evaluate upper limb impairment following SCI across 3 domains: strength, sensation, and prehension.

  Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])

Secondary Outcomes (10)

• Needle Electromyography

  Change in baseline EMG activity at 3 & 6 months

• Repetitive Nerve Stimulation

  Change in baseline neuromuscular junction transmission at 3 & 6 months

• Nerve Conduction Studies

  Change in baseline nerve conduction at 3 & 6 months

• F-Wave

  Change in baseline F-wave amplitude at 3 & 6 months

• H-Reflex

  Change in baseline H-reflex amplitude at 3 & 6 months

Study Arms (2)

Early FEST + TST

EXPERIMENTAL

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

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

Delayed FEST + TST

EXPERIMENTAL

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Lyndhurst Centre, KITE - TRI UHN

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Julio Furlan, MD, PhD

  KITE, Toronto Rehab-University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lamisa Etu, BSc

CONTACT

4165973422; LamisaFaria.Etu@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: June 2, 2021
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CA (1)