Time-effect of FEST+TST in the Upper-extremity Rehabilitation of Individuals With Traumatic SCI
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early FEST + TST Participants will receive FEST+TST at 3 to 6 months from SCI onset. |
Other: 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.
|
| Experimental: Delayed FEST + TST Participants will receive FEST+TST at 6 to 9 months from SCI onset. |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Spinal Cord Independence Measure (SCIM) [Change from baseline SCIM at 3 & 6 months]
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
- American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS) [Change from baseline ASIA UEMS score at 3 & 6 months (ASIA UEMS varies from 0 [complete tetraplegia) to 50 [normal])]
International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.
- ASIA Upper-Extremity Sensory Score (UESS) [Change from baseline ASIA UESS score at 3 & 6 months (ASIA UEMS varies from 0 [complete paralysis) to 50 [normal])]
International Standards for Neurological Classification of SCI (ISNCSCI) motor and sensory subscores will be used to evaluate degree of impairment.
- Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) [Change from baseline GRASSP score at 3 & 6 months (GRASSP score varies from o (complete paralysis) to 148 [normal])]
The GRASSP is a clinical measure used to evaluate upper limb impairment following SCI across 3 domains: strength, sensation, and prehension.
Secondary Outcome Measures
- Needle Electromyography [Change in baseline EMG activity at 3 & 6 months]
Disposable monopolar needles will be used to record the insertional activity, spontaneous activity (at rest) and motor unit action potentials (MUAPs) in selected distal muscles (i.e. abductor pollicis brevis and first dorsal interosseous muscles) and proximal muscles (i.e. pronator teres and flexor carpi ulnaris muscles) that are innervated by median and ulnar nerves, respectively, in the dominant (or weaker) upper extremity of each participant.
- Repetitive Nerve Stimulation [Change in baseline neuromuscular junction transmission at 3 & 6 months]
Stimulation of the median nerve (and ulnar nerve) in the dominant (or weaker) upper extremity of each individual will be applied using a bar electrode with the responses recorded in the abductor pollicis brevis (APB) muscle (and first dorsal interosseous muscle).
- Nerve Conduction Studies [Change in baseline nerve conduction at 3 & 6 months]
Supramaximal stimulation will be applied to the dominant (or weaker) upper extremity of each participant to determine the amplitude, distal latency and conduction velocity from the median and ulnar motor responses.
- F-Wave [Change in baseline F-wave amplitude at 3 & 6 months]
Percutaneous supramaximal stimulation will be applied distally to the median nerve (and ulnar nerve) in the dominant (or weaker) upper extremity of each individual with responses recorded from the abductor pollicis brevis muscle (and abductor digiti minimi muscle).
- H-Reflex [Change in baseline H-reflex amplitude at 3 & 6 months]
Percutaneous stimulation will be applied to the median nerve of the dominant (or weaker) upper extremity of each individual with responses recorded from the flexor carpi radialis (FCR) muscle using surface electrodes.
- Somatosensory Evoked Potentials (SSEPs) [Change in baseline SSEPs at 3 & 6 months]
Electrical stimulation will be applied to the median nerve (and ulnar nerve) in the distal portion of the dominant (or weaker) upper extremity. Recordings will be obtained from the contralateral C3/C4-Fz sites (based in the international 10/20 system) using surface electrodes.
- Motor Evoked Potentials (MEPs) [Change in baseline MEPs at 3 & 6 months]
Transcranial magnetic stimulation (TMS) will be used to evoke MEPs in the abductor pollicis brevis muscle (and first dorsal interosseous muscle) of the dominant (or weaker) upper extremity with the coil positioned over the contralateral motor cortex.
- Functional Magnetic Resonance Imaging (fMRI) [Change in baseline functional connectivity at 3 & 6 months]
Functional connectivity changes in the motor and somatosensory cortices and pathways will be examined using resting-state fMRI.
- Laboratorial Assessments (BDNF) [Change in baseline BDNF at 3 & 6 months]
Blood will be drawn to quantify the presence of brain derived neurotrophic factor [BDNF] in the blood.
- Laboratorial Assessments (NTF-3) [Change in baseline NTF-3 at 3 & 6 months]
Blood will be drawn to quantify the presence of neurotrophic factor 3 [NTF-3] in the blood.
Eligibility Criteria
Criteria
Inclusion Criteria:
• Subacute stage (<3 months) after traumatic, motor incomplete (AIS C or D), cervical SCI
Exclusion Criteria:
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Contraindications for neurophysiological tests
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Contraindications for FEST
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Medical conditions that can limit treatment protocols
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Other neurological diseases (i.e. peripheral neuropathies)
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Significant persisting mental illness;
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Learning disabilities;
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Substance abuse over 6 months prior to recruitment;
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Hearing and visual deficits sufficient to affect test performance;
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Contraindication to MRI scanning
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lyndhurst Centre, KITE - TRI UHN | Toronto | Ontario | Canada |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Julio Furlan, KITE, Toronto Rehab-University Health Network
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-6286