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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | November 18, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Asir John Samuel |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultra-Sound imaging | Muscle thickness measured through Ultra-Sound imaging | Change from baseline, and post 12 weeks of intervention will be measured. | |
Primary | 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. |
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