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

June 14, 2020 updated by: Asir John Samuel

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultra-Sound imaging
Time Frame: Change from baseline, and post 12 weeks of intervention will be measured.
Muscle thickness measured through Ultra-Sound imaging
Change from baseline, and post 12 weeks of intervention will be measured.
Gross motor function measure- 88
Time Frame: Change 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.
Change from baseline, and post 12 weeks of intervention will be measured.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asir John Samuel

Investigators

  • Principal Investigator: Neha Sharma, MPT, Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, Mullana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

August 31, 2021

Study Completion (ANTICIPATED)

November 18, 2021

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 14, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMDU/2019/03
  • U1111-1240-0890 (OTHER: UTN by WHO international clinical Trial Registry Platform)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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