NCT02727478 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Conradsson D, Lofgren N, Nero H, Hagstromer M, Stahle A, Lokk J, Franzen E
The Effects of Highly Challenging Balance Training in Elderly With Parkinson's Disease: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Oct;29(9):827-36. doi: 10.1177/1545968314567150. Epub 2015 Jan 21.
Conradsson D, Lofgren N, Stahle A, Hagstromer M, Franzen E
A novel conceptual framework for balance training in Parkinson's disease-study protocol for a randomised controlled trial. BMC Neurol. 2012 Sep 27;12:111. doi: 10.1186/1471-2377-12-111.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C
Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC
Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
Leavy B, Joseph C, Lofgren N, Johansson H, Hagstromer M, Franzen E
Outcome Evaluation of Highly Challenging Balance Training for People With Parkinson Disease: A Multicenter Effectiveness-Implementation Study. J Neurol Phys Ther. 2020 Jan;44(1):15-22. do

Highly Challenging Balance Training for People With Parkinson's Disease (the BETA-PD Study): Non-randomized Hybrid Effectiveness-implementation Trial

Clinical trial NCT02727478 - References