Spastic Diplegic Cerebral PalsyNCT04177186
Strength Training in Children With Spastic Diplegic and Hemiplegic Cerebral Palsy Receiving Botulinum Toxin
A study testing Strength training and Strength training with botulinum toxin in people with Spastic Diplegic Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Asir John Samuel.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- Strength training and Strength training with botulinum toxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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°
Who cannot join
- CSDCP and CHCP with any type of lower limb surgery within 3 months
- Children who are not willing to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
.
- Being tested
- Strength training, Strength training with botulinum toxin
- Keywords
- Cerebral palsy, Botox
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Strength training for hamstring and gastrocnemius only, pre and post 12 weeks of intervention
Strength training with botulinum toxinCombination product
Strength training for hamstring and gastrocnemius with Ultra Sound Imaging method, pre and post 12 weeks of intervention
| Study group | Role | What they receive |
|---|---|---|
| strength training group | Experimental | ST group only strength training will be provided. Receives: Other: Strength training |
| strength training with botulinum toxin | Experimental | BT-ST group, strength training will be provided after the administering Botulinum toxin into the muscle belly guided under Ultra sound imaging. Receives: Combination Product: Strength training with botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultra-Sound imaging
Muscle thickness measured through Ultra-Sound imaging
Measured: 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.
Measured: Change from baseline, and post 12 weeks of intervention will be measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Oct 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion18 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spastic Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Neha Sharma, MPT, Principal investigator, Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, Mullana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177186
- Sponsor's protocol ID
- MMDU/2019/03
- Other IDs
- U1111-1240-0890
- Status last verified
- Jun 2020
- First submitted
- 20 Nov 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31453540Juneja 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.
PubMed 29578189Williams 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.
PubMed 23789782Hastings-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.
PubMed 26589633Kaushik 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.
PubMed 30937086
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04177186
- Acronym / sponsor ID
- MMDU/2019/03
- Keywords
- Cerebral palsy, Botox
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 18 Nov 2021 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strength training group | Experimental | Other: Strength trainingST group only strength training will be provided. |
| strength training with botulinum toxin | Experimental | Combination Product: Strength training with botulinum toxinBT-ST group, strength training will be provided after the administering Botulinum toxin into the muscle belly guided under Ultra sound imaging. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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°
Key exclusion criteria (2 listed)
- CSDCP and CHCP with any type of lower limb surgery within 3 months
- Children who are not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength trainingStrength training for hamstring and gastrocnemius only, pre and post 12 weeks of intervention | Other | strength training group |
| Strength training with botulinum toxinStrength training for hamstring and gastrocnemius with Ultra Sound Imaging method, pre and post 12 weeks of intervention | Combination product | strength training with botulinum toxin |
Primary outcome
Ultra-Sound imaging
Time frame: Change from baseline, and post 12 weeks of intervention will be measured.
Muscle thickness measured through Ultra-Sound imaging
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 31453540Yigitoglu 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.
- Background: PubMed 29578189Juneja 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.
- Background: PubMed 23789782Williams 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.
- Background: PubMed 26589633Hastings-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.
- Background: PubMed 30937086Kaushik 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.
- A Randomized Control Trial of Botulinum Toxin A Administration under Ultrasound Guidance against Manual Palpation in Spastic Cerebral Palsy.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, MPT principal investigator
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, Mullana
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and Strength training with botulinum toxin in people with Spastic Diplegic Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Asir John Samuel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asir J Samuel, MPT, (PhD) (8059930222, asirjohnsamuel@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultra-Sound imaging (time frame: Change from baseline, and post 12 weeks of intervention will be measured.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177186, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.