An interventional study of Strength training and Strength training with botulinum toxin in Spastic Diplegic Cerebral Palsy and Hemiplegic Cerebral Palsy, sponsored by Asir John Samuel. Status unknown. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.
Sponsored by Asir John Samuel · Not applicable, Interventional, and Treatment
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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703 studies on the registry are indexed under Muscle Spasticity; 148 are open to participants now.
This study's planned enrollment of 40 is above the median of 36 across 524 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Asir John Samuel is the lead sponsor of 26 studies on the registry; none are open to participants now.
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Exclusion Criteria:
ST group only strength training will be provided.
Other: Strength training
BT-ST group, strength training will be provided after the administering Botulinum toxin into the muscle belly guided under Ultra sound imaging.
Combination Product: Strength training with botulinum toxin
Strength training for hamstring and gastrocnemius only, pre and post 12 weeks of intervention
Strength training for hamstring and gastrocnemius with Ultra Sound Imaging method, pre and post 12 weeks of intervention
Ultra-Sound imaging
Muscle thickness measured through Ultra-Sound imaging
Time frame: Change from baseline, and post 12 weeks of intervention will be measured.
Gross motor function measure- 88
Gross motor function measure- 88 helps in measuring the activities in standing and walking.
Time frame: Change from baseline, and post 12 weeks of intervention will be measured.
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Asir John Samuel