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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times [at weeks 0, 8, and 12] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Active Comparator | For the immediate intervention group, each participant will complete the following:
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| Waitlist Control | Active Comparator | The waitlist control group will participate in a protocol similar to the immediate intervention group, except:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Intervention | Behavioral | Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Capabilities of Upper Extremity Questionnaire (CUE-Q) | The CUE-Q version 2.1 measures functional limitation and perceived difficulty of performing actions with upper extremities in individuals with tetraplegia. The CUE-Q has 32 items; each scored on a 1-to-7-point scale representing self-perceived difficulty with total scores ranging from 32 to 224 (higher scores demonstrating greater UE function) and right and left scores assessed separately | Weeks 0, 8, 12, 21, and 25 |
| 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 | Weeks 0, 8, 12, 21, and 25 |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Information | Demographic information will include: age, sex, race/ethnic background, pre-injury education, employment status, marital status, and living situation. | Week 0 |
| Injury Characteristics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candy Tefertiller, PT, DPT, PhD, NCS | Contact | 303-789-8000 | ctefertiller@craighospital.org | |
| Bria Mellick, MS | Contact | 303-789-8757 | bmellick@craighospital.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Recruiting | Englewood | Colorado | 80113 | United States |
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| Waitlist control | Behavioral | Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment. |
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The ISNCSCI is a universal classification tool for SCI based on a standardized sensory and motor exam. The ISNCSCI involves a detailed examination to determine the sensory and motor levels for both the right and left sides, the overall neurological level of the injury, and the completeness of the injury as designated by the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS). The motor exam also results in a total Upper Extremity Motor Score (UEMS) ranging from 0 to 50, with higher scores indicative of greater UE strength. |
| Weeks 0, 8, 12, 21, and 25 |
| Pinch and Grasp Force | Pinch and grasp force will be measured by the Commander Echo Console with the JTech Pinch and Hand Dynamometer to quantify finger and grasp strength. | Weeks 0, 8, 12, 21, and 25 |
| Global Rating of Change (GRC) | The GRC assesses perceived change from an intervention. The scale is designed to quantify an individual's perceived improvement or deterioration over time. The magnitude of the change is then scored on a visual analog scale. GRC scales have been recommended for use as a core outcome measure in rehabilitation studies to improve the applicability of information from clinical trials to clinical practice. | Weeks 8, 12, 21, and 25 |
| Satisfaction with Treatment Scale | The Satisfaction with Treatment Scale is a 6-point scale (0=strongly disagree; 5= strongly agree) used to rate satisfaction with treatment in previous intervention studies conducted in the home environment85 and will be modified specifically to address the transcutaneous spinal stimulation (TSS) intervention. | Weeks 8, 12, 21, and 25 |
| Qualitative Questions | Participants and caregivers will be asked questions regarding their experience during the intervention, such as their likes and dislikes, notable changes or observations, and overall satisfaction with using TSS in their homes | Weeks 8 and 21 |
| Canadian Occupational Performance Measure (COPM) | The COPM is an individualized, client-centered instrument designed to measure an individual's self-perception of physical functioning and satisfaction in the activities identified as important by the client. The COPM will directly assess the true importance of functional improvements with regard to the subject's ability to perform activities of daily living and/or to function occupationally. | Weeks 0, 8, 12, 21, and 25 |
| International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0 | This instrument measures self-reported quality of life across four domains: overall well-being, physical health, psychological health, and social life. For each domain, respondents are asked to rate their satisfaction on a 0-10 scale (0=completely dissatisfied; 10=completely satisfied). | Weeks 0, 8, 12, 21, and 25 |
| International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0 | This instrument identifies pain region, pain type (e.g., nociceptive, neuropathic), and treatments used to reduce pain in addition to pain intensity on a 0-10 scale (0=no pain; 10=pain as bad as you can imagine) and interference with various aspects of the respondent's life on a 0-10 scale (0=no interference; 10=extreme interference). | Weeks 0, 8, 12, 21, and 25 |
Injury information will include: date of injury, cause of injury, baseline AIS classification, and injury level.
| Week 0 |