Strength Training in Children With Spastic Diplegic and Hemiplegic Cerebral Palsy Receiving Botulinum Toxin

Study Overview
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Brief Summary
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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.

Detailed Description
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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. .

Official Title
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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

Conditions
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Spastic Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy

Intervention / Treatment
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* Other: Strength training
* Combination Product: Strength training with botulinum toxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with spastic diplegic cerebral palsy (CSDP) and children with hemiplegic cerebral palsy (CHCP) in GMFCS level I, II and III. CSDCP and CHCP aged between 5 to 17 years Ankle dorsiflexion <5° Knee extension < 90° Exclusion Criteria: CSDCP and CHCP with any type of lower limb surgery within 3 months Children who are not willing to participate in the study

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: strength training group<br>ST group only strength training will be provided. | Other: Strength training<br>* Strength training for hamstring and gastrocnemius only, pre and post 12 weeks of intervention<br>|
| Experimental: strength training with botulinum toxin<br>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<br>* Strength training for hamstring and gastrocnemius with Ultra Sound Imaging method, pre and post 12 weeks of intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultra-Sound imaging | Muscle thickness measured through Ultra-Sound imaging | 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. | Change from baseline, and post 12 weeks of intervention will be measured. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral palsy, Botox