Cervical Spinal Cord Injury
Conditions
Keywords
Nerve Transfer Surgery, Tendon Transfer Surgery, Decision Support Intervention
Brief summary
The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting of cervical spinal cord injury. Eligible study participants will be recruited across the 4 sites and the investigators plan to recruit the following groups and numbers of participants: 1. Nerve or tendon transfer recipients: people who have elected to undergo nerve (N=10) or tendon (N=10) transfer surgery to restore some hand and arm function as part of their standard clinical care and their caregiver (N=20) 2. Non-surgical control group: people with cervical SCI (N=20) and their caregiver (N=20)
Detailed description
At present, there is limited information that provides the exact time course and probability of gain in specific function (such as hand function) that might help patients and clinicians make decisions regarding novel and time-sensitive surgical treatment options. Understanding the pros and cons of any surgical intervention, especially in the setting of complex and often incomplete information, is challenging. Ultimately, this project will create a decision support intervention (DSI) that can be used to help clinicians and people living with cervical level SCI and their caregivers. It will be most useful to those with acute or sub-acute injury (\< 1year after SCI) for both military personnel and the general public. Clinicians and patients will have evidence to help them make decisions about treatments to improve upper extremity function. In such a manner, patients can make more well-informed choices that are consistent with their values, needs and goals.
Interventions
OTHERSemi-structured interview
Semi-structured interviews to be conducted by a study team member.
OTHERSpinal Cord Independence Measure (SCIM-SR)
The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
OTHERSF-36
A health-related quality of life (QoL) self-reported survey.
Sponsors
United States Department of Defense
VA St. Louis Health Care System
VA Palo Alto Health Care System
Stanford University
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
CERVICAL SPINAL CORD INJURY PARTICIPANTS Inclusion criteria: * Adult subjects (≥18 years and \< 80 years) with cervical level SCI ASIA A, B or C (minimum 6 months and maximum 20 years post-injury).
Exclusion criteria
* Patient who chooses simultaneous tendon and nerve transfer procedure (this would preclude separation of the influence of one surgery compared to the other) * Patient has ASIA D status (these patients may have progressive return of functionally useful motor function below the level of the SCI and would not routinely be offered acute surgical intervention and their experiences are less-relevant to the target patient population). CAREGIVER PARTICIPANTS Inclusion criteria: * At least 18 years of age * Able to answer questions about the primary participant's experiences with cervical spinal cord injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative (interview) Analysis | 24 months | All interviews will be transcribed verbatim and analyzed using standard qualitative text analysis. Members of the research team will read the transcripts for accuracy and to determine potential topics for coding. The investigators will develop a codebook using inductive and deductive codes. Deductive codes will be directly linked to our research questions. Adding inductive codes, where topics and codes are not pre-determined but are derived directly from the data, will allow the research team to develop a sense of how patients experience the surgical process, and allows for unexpected findings to emerge. Once the codebook is determined, two members of the research team will code the transcripts. Codes will be compared between raters. The investigators will use the codes to infer themes in the data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative (survey) Data Analysis | 24 months | The data analysis will be conducted within each group. To account for correlations among repeated measures from the same patient, the longitudinal data will be analyzed using a mixed model to examine the change in survey outcomes. |
Countries
United States
Outcome results
None listed