NCT04230278 - 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)

Dusing SC, Harbourne RT, Hsu LY, Koziol NA, Kretch K, Sargent B, Jensen-Willett S, McCoy SW, Vanderbilt DL
The SIT-PT Trial Protocol: A Dose-Matched Randomized Clinical Trial Comparing 2 Physical Therapist Interventions for Infants and Toddlers With Cerebral Palsy. Phys Ther. 2022 Jul 4;102(7):pzac039. doi: 10.1093/ptj/pzac039.
Dusing SC, Harbourne RT, Lobo MA, Westcott-McCoy S, Bovaird JA, Kane AE, Syed G, Marcinowski EC, Koziol NA, Brown SE
A Physical Therapy Intervention to Advance Cognitive and Motor Skills: A Single Subject Study of a Young Child With Cerebral Palsy. Pediatr Phys Ther. 2019 Oct;31(4):347-352. doi: 10.1097/PEP.0000000000000635.
Fiss AL, Hakstad RB, Looper J, Pereira SA, Sargent B, Silveira J, Willett S, Dusing SC
Embedding Play to Enrich Physical Therapy. Behav Sci (Basel). 2023 May 24;13(6):440. doi: 10.3390/bs13060440.
Kretch KS, Dusing SC, Harbourne RT, Hsu LY, Sargent BA, Willett SL
Early Mobility and Crawling: Beliefs and Practices of Pediatric Physical Therapists in the United States. Pediatr Phys Ther. 2024 Jan 1;36(1):9-17. doi: 10.1097/PEP.0000000000001063.
Kretch KS, Koziol NA, Marcinowski EC, Hsu LY, Harbourne RT, Lobo MA, McCoy SW, Willett SL, Dusing SC
Sitting Capacity and Performance in Infants with Typical Development and Infants with Motor Delay. Phys Occup Ther Pediatr. 2024;44(2):164-179. doi: 10.1080/01942638.2023.2241537. Epub 2023 Aug 7.

Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy

Clinical trial NCT04230278 - References