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Supporting Patient Decisions About UE Surgery in Cervical SCI

NCT03464409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-11-03

No results posted yet for this study

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)

Conditions

  • Cervical Spinal Cord Injury

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • VA St. Louis Health Care System

    collaborator FED

  • VA Palo Alto Health Care System

    collaborator FED

  • Stanford University

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Ida K Fox, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-13
Primary Completion
2021-08-30
Completion
2021-08-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03464409 on ClinicalTrials.gov