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Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire

Study acronym: NAHPq
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 2025 to Dec 2026v3
  2. Lead sponsor: Silvia Faccioli to Azienda USL Reggio Emilia - IRCCSv2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Feb 2025 to Jul 17, 2024
    • Collaborators: 2 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is twofold: 1. to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently 2. to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia Researchers will : 1. involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire 2. assess construct validity and reliability of the questionnaire submitting it to 100 care givers of pediatric patients with quadriplegia, and comparing results with the Revised Face Legs Activity Cry and Consolability (r-FLACC) Scale assessed by the physiatrist during the visit Participants will: 1. as experts, firstly answer open questions on this topic, secondly evaluate each item of the new questionnaire by means of a 5-point Liekert scale 2. as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit
Trial Details
NCT Number NCT06798233
Lead Sponsor Azienda USL Reggio Emilia - IRCCS
Collaborators: IRCCS Fondazione Stella Maris
Conditions
(from sponsor)		 Quadriplegia/Tetraplegia
Related terms Cerebral Palsy, Quadriplegia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov