NCT04578743

Exercise as Concussion Therapy Trial- 2

Exercise as Concussion Therapy Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ANSwers Neuroscience, Inc. · Industry
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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: 1. ClearHeart©, ANSwers Neuroscience Pty Ltd commercial prototype for cold pressor testing, compared to ice bucket testing. 2. ClearPlay©, ANSwers Neuroscience Pty Ltd commercial prototype based on the joint position error test to assess "whiplash".

Detailed description

Study Type: Interventional Estimated Enrollment: 400 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Therapeutic Intervention, Open-Label Study to Compare the Efficacy and Safety of Graded Exercise Compared to Passive Stretching in Subjects Who Have Sustained a Mild Traumatic Brain Injury Estimated Study Start Date: October 1, 2020 Estimated Primary Completion Date: September 30, 2022 Estimated Study Completion Date: September 30, 2023

Conditions

• Mild Traumatic Brain Injury
• Concussion, Mild

Interventions

Type	Name	Description
DEVICE	Graded Exercise Therapy: ClearPlay(TM)	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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2020-10-08
• Last updated: 2022-03-03

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated device study