Supporting Patient Decisions About UE Surgery in Cervical SCI

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    80
  • sponsor
    Washington University School of Medicine
Updated on 25 January 2021

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)

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.

Details
Condition Cervical Spinal Cord Injury
Treatment semi-structured interview, Spinal Cord Independence Measure (SCIM-SR), SF-36
Clinical Study IdentifierNCT03464409
SponsorWashington University School of Medicine
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Cervical Spinal Cord Injury?
Do you have any of these conditions: Do you have Cervical Spinal Cord Injury??
At least 18 years of age
Able to answer questions about the primary participant's experiences with cervical spinal cord injury

Exclusion Criteria

The caregiver/spouse declines to participate in the study. Note: Caregiver participation is preferred, but not required, for SCI participant enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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