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Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 26, 2026 → May 31, 2027
See other at-risk trials from Father Flanagan's Boys' Home

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 26, 2026 to May 31, 2027v11
  2. Primary completion date: May 31, 2025 to May 26, 2026
    • Study completion date: May 31, 2026 to May 31, 2027
    v10
  3. Study completion date: May 31, 2025 to May 31, 2026v9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  5. Primary completion date: May 31, 2024 to May 31, 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: May 2024 to May 31, 2024
    • Study completion date: May 2025 to May 31, 2025
    v5
  3. Lead sponsor: University of Nebraska to Father Flanagan's Boys' Home
    • Start date: Jul 13, 2020 to Aug 3, 2020
    • Study site revised
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary endpoints: 7 to 9
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2020 to Jul 13, 2020
    • Secondary endpoints expanded, about 160 words
    • Study description expanded, about 16 words
  5. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments. After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline. Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.
Trial Details
NCT Number NCT04360395
Lead Sponsor Father Flanagan's Boys' Home
Conditions
(from sponsor)		 Cerebral Palsy
Related terms Cerebral Palsy
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov