Strength Training in Children With Spastic Diplegic and Hemiplegic Cerebral Palsy Receiving Botulinum Toxin
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
2 other identifiers
interventional
40
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2021
CompletedJune 16, 2020
June 1, 2020
11 months
November 20, 2019
June 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (2)
strength training group
EXPERIMENTALST group only strength training will be provided.
strength training with botulinum toxin
EXPERIMENTALBT-ST group, strength training will be provided after the administering Botulinum toxin into the muscle belly guided under Ultra sound imaging.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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°
You may not qualify if:
- CSDCP and CHCP with any type of lower limb surgery within 3 months
- Children who are not willing to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asir John Samuellead
Related Publications (5)
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.
PMID: 31453540BACKGROUNDJuneja 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.
PMID: 29578189BACKGROUNDWilliams 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.
PMID: 23789782BACKGROUNDHastings-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.
PMID: 26589633BACKGROUNDKaushik 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.
PMID: 30937086BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha Sharma, MPT
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, Mullana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The study will follow double-blinding/ masking. As the outcome assessor and the participant will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 26, 2019
Study Start
October 1, 2020
Primary Completion
August 31, 2021
Study Completion
November 18, 2021
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share