Study Stopped
COVID-induced lockdowns.
Exercise as Concussion Therapy Trial- 2
ExACTT
Sponsor study identifier
interventional
0
1 country
3
Study Start
October 1, 2020
Actual (reported)Primary Completion
September 30, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)This study is a Phase 2, open-label study of a therapeutic intervention (graded exercise)compared to a reference therapy (passive stretching) in patients who have sustained mTBI. Subjects will be randomly assigned with a ratio of 1:1 to complete either graded exercise or passive stretching using a parallel-group design. The effects of graded exercise and passive stretching will be compared using ClearPlay© (ANSwers Neuroscience Pty Ltd commercial mobile application) The study will also validate the performance of two devices:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2020
Actual (reported)October 1, 2020
Actual (reported)October 8, 2020
Actual (reported)September 30, 2021
Actual (reported)September 30, 2021
Actual (reported)ExACTT
The primary objective of the study is to compare the effects of graded exercise and passive stretching using ClearPlayTM (ANSwers Neuroscience Pty Ltd commercial mobile application) on recovery following mTBI in the Australian setting.
2 Years
ClearPlay(TM): a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, will provide a telemetry-based graded exercise program for 20 minutes each day, identifying a heart rate target that will be advanced weekly for up to 8 weeks as symptoms resolve.
ClearPlay(TM): we have created a passive stretching program (placebo arm) downloadable to an Apple i-touch or i-phone device, that will provide a telemetry-based guided passive stretching program for 20 minutes each day for up to 8 weeks as symptoms resolve.
ClearPlayTM; a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, that provides a telemetry-based graded exercise program that enables remote monitoring of symptoms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
University of Queensland
Brisbane, Queensland, 4101, Australia
Alfred Health
Melbourne, Victoria, 3004, Australia
Christina Master, MD
Children's Hospital of Philadelphia
0 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2020
First Posted
October 8, 2020
Study Start
Post-Concussion Aerobic Exercise
Contact the study team to confirm eligibility.
October 1, 2020
Actual (reported)Primary Completion
September 30, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)Last Updated
March 3, 2022
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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