NCT04177186 - 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)

Hastings-Ison T, Blackburn C, Rawicki B, Fahey M, Simpson P, Baker R, Graham K
Injection frequency of botulinum toxin A for spastic equinus: a randomized clinical trial. Dev Med Child Neurol. 2016 Jul;58(7):750-7. doi: 10.1111/dmcn.12962. Epub 2015 Nov 20.
Juneja M, Jain R, Gautam A, Khanna R, Narang K
Effect of multilevel lower-limb botulinum injections & intensive physical therapy on children with cerebral palsy. Indian J Med Res. 2017 Nov;146(Supplement):S8-S14. doi: 10.4103/ijmr.IJMR_1223_15.
Kaushik PS, Gowda VK, Shivappa SK, Mannapur R, Jaysheel A
A Randomized Control Trial of Botulinum Toxin A Administration under Ultrasound Guidance against Manual Palpation in Spastic Cerebral Palsy. J Pediatr Neurosci. 2018 Oct-Dec;13(4):443-447. doi: 10.4103/JPN.JPN_60_18.
Williams SA, Reid S, Elliott C, Shipman P, Valentine J
Muscle volume alterations in spastic muscles immediately following botulinum toxin type-A treatment in children with cerebral palsy. Dev Med Child Neurol. 2013 Sep;55(9):813-20. doi: 10.1111/dmcn.12200. Epub 2013 Jun 22.
Yigitoglu P, Kozanoglu E
Effectiveness of electrical stimulation after administration of botulinum toxin in children with spastic diplegic cerebral palsy: A prospective, randomized clinical study. Turk J Phys Med Rehabil. 2019 Feb 4;65(1):16-23. doi: 10.5606/tftrd.2019.2236. eCollection 2019 Mar.

Effectiveness of Strength Training After Administration of Botulinum Toxin in Children With Spastic Diplegic and Hemiplegic Cerebral Palsy on Muscle Volume and Gross Motor Function: A Prospective, Double-blind, Randomized Clinical Trial

Details for clinical trial NCT04177186

Clinical trial NCT04177186 - References