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Blood Flow Restriction Training After Patellar INStability

Study acronym: BRAINS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from Caitlin Conley

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2027v13
  2. Primary and study completion dates: Jun 2025 to Jun 30, 2026
    • Site contacts updated at 2 of 4 sites
    v12
  3. Study sites: 2 to 4v11
  4. Primary and study completion dates: Jun 2024 to Jun 2025v10
  5. Site contacts updated at 1 of 2 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Phase: Phase 2 to Not applicable
    • Study description shortened, about 34 words
    v8
  2. Lead sponsor: Caitin Conley to Caitlin Conley
    • Secondary endpoints expanded, about 16 words
    v7
  3. Lead sponsor: Cale Jacobs, PhD to Caitin Conleyv6
  4. Enrollment target: 156 to 78v5 Show 5 more changesShow less
    • Interventions: Blood Flow Restriction Training (Device), Normal saline (Drug), Sham Blood Flow Restriction Training (Device), Sham Injection (Other) to Blood Flow Restriction Training (Device), Sham Blood Flow Restriction Training (Device)
    • Eligibility criteria shortened, about 10 words
    • Study description shortened, about 173 words
    • Study arms: 4 to 2
    • Study title shortened, about 2 words
  5. 2 versions Re-verified since Oct 19, 2020, no change to tracked fieldsv3-v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2020 to Sep 9, 2020
    • Site details revised at 2 of 2 sites
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
Trial Details
NCT Number NCT04554212
Lead Sponsor Caitlin Conley
Collaborators: The Cleveland Clinic
Conditions
(from sponsor)		 Patellar Dislocation, Knee Injuries, Leg Injury, Wounds and Injuries
Related terms Knee Injuries, Leg Injuries, Patellar Dislocation, Wounds and Injuries
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov