Hemiplegic Cerebral Palsy Clinical Trial
Official title:
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
To estimate the effectiveness of strength training after administration of botulinum toxin in children with spastic diplegic cerebral palsy and hemiplegic cerebral palsy on muscle volume and gross motor function. Forty Children with spastic diplegic cerebral palsy (CSDP) and children with hemiplegic cerebral palsy (CHCP) in GMFCS levels I, II and III will be recruited by the convenience sampling method. Thickness of both hamstring and gastrocnemius will be recorded with Ultra Sound Imaging method, pre and post 12 weeks of intervention. In ST group only strength training will be provided. While in BT-ST group, strength training will be provided after the administering Botulinum toxin into the muscle belly guided under Ultra sound imaging. Pre-post intervention differences in muscle thickness and gross motor function will be recorded and analysed.
Botulinum toxin is a neurotransmitter produced by clostridium Botulinum. It is the one of the
most beneficial method for treating spasticity and providing functional improvement. By
reducing the spasticity, the available muscle can be utilized to perform functional
activities. Muscle volume decreases following the administration of Botulinum toxin to the
neuromuscular junction. Strength training has positive impact on improving muscle volume.
There are few studies are available regarding the exercise training following the
administration of Botulinum toxin to the neuromuscular junction. But to the best of the
investigators knowledge, there is no study available regarding the effectiveness of strength
training on muscle volume and gross motor function following the administration of Botulinum
toxin to the neuromuscular junction.2. To determine the effectiveness of strength training on
muscle volume estimated by Ultrasound imaging following the administration of Botulinum toxin
to hamstring and gastrocnemius is the objective of the study. The study protocol was approved
by the institutional research advisory committee (RAC) and registered under the Universal
Trial Number (UTN), U1111-1240-0890. The protocol will be registered under
ClinicalTrials.gov, under World Health Organization International Clinical Trials Registry
Platform and then the study will be submitted for the ethical approval by institutional
ethics committee of Maharishi Markandeshwar Deemed to Be University, Mullana, and Haryana
with unique reference number. The study will be executed in accordance with the principles of
the Declaration of Helsinki (Revised, 2013) and National ethical guidelines for Biomedical
and Health research involving human participants by Indian council for medical research
(ICMR, 2017). The purpose of the study will be clearly explained to the patient with Head and
neck cancer. Written informed consent form will be obtained from the recruited patients.
Total of X CSDCP and CHCP will be screened and through convenience sampling method, 34
children will be selected based on the inclusion criteria for the cross-over trail design.
Demographic data will be recorded for all the recruited children.
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