Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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Ninety-nine individuals meeting the study's inclusion/exclusion criteria will be enrolled in this study. The objective of this study is to evaluate three different therapeutic approaches to synergistically retrain functional movement patterns of the upper extremities in combination with trunk stabilization to promote neurologic and functional recovery after SCI. Each subject will complete 40 sessions of intervention. Subjects will also complete a Baseline Evaluation (week 0), Re-Evaluation (week 4), Post Treatment Evaluation (week 8), and a Follow-Up Evaluation (week 12).

Official Title
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Improving Upper Extremity Function and Trunk Stability After Cervical Spinal Cord Injury (SCI): A Randomized Controlled Trial of Three Interventions

Conditions
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Cervical Spinal Cord Injury

Intervention / Treatment
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* Behavioral: FTP Alone
* Behavioral: FTP+Con-FES
* Behavioral: FTP+WPHF-FES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of traumatic SCI Less than 5months post SCI SCI injury level C1-C8 SCI categorized as AIS B-D Currently receiving inpatient rehabilitation at Craig Hospital Passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows Demonstrate motor response to electrical stimulation in majority of UE muscle groups below level of injury (tested during screening) No complicating physical or cognitive conditions (as determined by their physician) that would preclude safe use of electrical stimulation Able to complete study as an outpatient if discharged from inpatient rehabilitation before completing 40 sessions of training Exclusion Criteria: Unstable chronic cardiac or respiratory complaints Current or history of UE contracture or skin pressure injuries that might interfere with intervention Received Botox injections within the last 3 months Pregnant Implanted devices including: pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intra-thecal pump.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FTP Alone<br>Functional Task Practice Alone - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks followed by 10 minutes of functional training/carryover in a relevant environment without functional electrical stimulation (FES). | Behavioral: FTP Alone<br>* Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins).<br>|
| Active Comparator: FTP+Con-FES<br>Functional Task Practice + Conventional Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with conventional parameter (200µs; 40Hz) functional electrical stimulation (FES). followed by 10 minutes of functional training/carryover in a relevant environment. | Behavioral: FTP+Con-FES<br>* Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing conventional parameter FES.<br>|
| Active Comparator: FTP+WPHF-FES<br>Functional Task Practice + Wide Pulse, High Frequency Functional Electrical Stimulation - Participants allocated to this group will complete 40 minutes of training focused on improving functional tasks supplemented with wide pulse, high frequency (1000µs; 100 Hz) functional electrical stimulation (FES) followed by 10 minutes of functional training/carryover in a relevant environment. | Behavioral: FTP+WPHF-FES<br>* Participants will be challenged with training speed, weight, limited therapist support, and context variation (e.g., fine motor activities will vary using objects such as cards, dice, coins). Muscle groups will be stimulated at the same time they would be activated naturally in a pre-injury movement pattern utilizing wide pulse, high frequency parameter FES.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capabilities of Upper Extremity Test (CUE-T) | 32 item test, each item scored on a 0-4 point scale with total scores ranging from 0-128. | Week 0 to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) | This multimodal test measures sensorimotor and prehension function in three domains important in describing arm and hand function | Week 0, Week 8, and Week 12 | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Level | The ISNCSCI involves a detailed examination to determine the sensory level for the right and left sides. The sensory level is the most caudal, intact dermatome. Scores range from 0-2. The higher the score the more intact the dermatome is. | Week 0, Week 8, and Week 12 | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Level | The ISNCSCI involves a detailed examination to determine motor levels for the right and left sides. The motor level is defined as the lowest key muscle function that has a grade of at least a 3, providing key muscle functions represented by segments above that level are judged to be intact. Scores range from 0-5. The higher the score the more intact the muscle is. | Week 0, Week 8, and Week 12 | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurological Level of Injury | The ISNCSCI involves a detailed examination to determine the neurological level of injury. The neurological level of injury refers to the most caudal segment of the cord with intact sensation and antigravity muscle function strength, provided that there is normal sensory and motor function rostrally respectively. The neurological level of injury is the most cephalad of the sensory and motor levels. | Week 0, Week 8, and Week 12 | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sacral Sparing | The ISNCSCI involves a detailed examination to determine whether a spinal cord injury is complete or incomplete. If an injury is considered complete there is an absence of voluntary anal contraction, absent sensory scores of S4-5, and absence of deep anal pressure. | Week 0, Week 8, and Week 12 | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Impairment Grade | The ISNCSCI involves a detailed examination to determine a spinal cord injury's grade according to the American Spinal Injury Association. Score ranges from A-E. ASIA classification A means spinal injury is considered complete with no sensory or motor function preserved in sacral segments. On the opposite end of the scale an ASIA classification E means 'normal'. | Week 0, Week 8, and Week 12 | 
| Pinch Force | Pinch force will be measured by the Commander Echo Console with the JTech Pinch Dynamometer to quantify finger strength. | Week 0, Week 8, and Week 12 | 
| Grasp Force | Grasp force will be measured by the Commander Echo Console with the JTech Hand Dynamometer to quantify grasp strength. | Week 0, Week 8, and Week 12 | 
| Modified Functional Reach (MFR) | The MFR will be used to measure dynamic trunk stability | Week 0, Week 8, and Week 12 | 
| Global Rating of Change (GRC) | The Global Rating of Change scale assesses perceived change from an intervention. 9 point Likert scale. Higher positive score reflects great improvement | Week 0, Week 8, and Week 12 | 
| NeuroRecovery Scale (NRS) | The full NRS comprises of 16items. For the purpose of this upper extremity interventional study, only six items will be used that represent a variety of functional upper extremity movement patterns required for ADL management. These scores will be used to guide treatment across all 3 groups. Scores range from 1A-4C. Higher scores reflect greater recovery of spinal cord injury. | Week 0 and Week 4 | 
| Demographic Information | Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation. | Week 0 | 
| Injury Information | Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level. | Week 0 |