NCT03464409

Supporting Patient Decisions About UE Surgery in Cervical SCI

Supporting Patient Decisions About Upper Extremity Surgery in Cervical Spinal Cord Injury (Aim 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Spinal Cord Injury

Interventions

Type	Name	Description
OTHER	Semi-structured interview	Semi-structured interviews to be conducted by a study team member.
OTHER	Spinal 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.
OTHER	SF-36	A health-related quality of life (QoL) self-reported survey.

Timeline

• Start date: 2018-03-13
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2018-03-14
• Last updated: 2021-11-03

Locations

4 sites across 1 country: United States