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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04177186
Enrollment
40
Registered
2019-11-26
Start date
2020-10-01
Completion date
2021-11-18
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegic Cerebral Palsy, Spastic Diplegic Cerebral Palsy

Keywords

Cerebral palsy, Botox

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.

Detailed description

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. .

Interventions

OTHERStrength training

Strength training for hamstring and gastrocnemius only, pre and post 12 weeks of intervention

COMBINATION_PRODUCTStrength training with botulinum toxin

Strength training for hamstring and gastrocnemius with Ultra Sound Imaging method, pre and post 12 weeks of intervention

Sponsors

Asir John Samuel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The study will follow double-blinding/ masking. As the outcome assessor and the participant will be blinded.

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ultra-Sound imagingChange from baseline, and post 12 weeks of intervention will be measured.Muscle thickness measured through Ultra-Sound imaging
Gross motor function measure- 88Change from baseline, and post 12 weeks of intervention will be measured.Gross motor function measure- 88 helps in measuring the activities in standing and walking.

Contacts

Primary ContactAsir J Samuel, MPT, (PhD)
asirjohnsamuel@mmumullana.org8059930222
Backup ContactVencita Aranha, MPT, (PhD)
vencita.peds@mmumullana.org9483909525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026