Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04177186
Other study ID # MMDU/2019/03
Secondary ID U1111-1240-0890
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date November 18, 2021

Study information

Verified date June 2020
Source Maharishi Markendeswar University (Deemed to be University)
Contact Asir J Samuel, MPT, (PhD)
Phone 8059930222
Email asirjohnsamuel@mmumullana.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.

.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Asir John Samuel

References & Publications (5)

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

Outcome

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.
See also
  Status Clinical Trial Phase
Completed NCT04635930 - Taping and Traditional Exercises in Upper Limb Function in Hemiplegic N/A
Terminated NCT03811275 - Task or Virtual Reality Intervention for Improving UE Function N/A
Completed NCT05068596 - Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy N/A
Completed NCT03626077 - Biofeedback Training and Physical Therapy Program Improves Visual-motor Integration in Children With Cerebral Palsy N/A
Terminated NCT04009031 - Video Game for Home-based Rehabilitation for Children With Hemiplegia N/A
Completed NCT01973426 - Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis
Recruiting NCT03361930 - Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk N/A
Completed NCT03691506 - Comparison of CIMT and Its Modified Form on Upper Motor Function Outcomes in Hemiplegic Cerebral Palsy. N/A
Completed NCT05062122 - The Effects of Vibration and Kinesiology Tape Applications in Children With Hemiplegic Cerebral Palsy
Completed NCT06021899 - Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP N/A
Recruiting NCT05011201 - Dual Joint Visual Feedback Gait Retraining in Pediatric Hemiplegic Cerebral Palsy N/A
Recruiting NCT05559320 - Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy N/A
Recruiting NCT06040619 - Implementation of Therapy Together N/A
Completed NCT06330831 - Intensive Group Based CIMT for Young Children N/A
Recruiting NCT06001983 - Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy N/A
Recruiting NCT05931640 - Effects of Plyometric Training Versus Virtual Reality Among Hemiplegic Cerebral Palsy N/A
Completed NCT04894812 - Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy N/A
Completed NCT05396053 - Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy N/A
Completed NCT05380011 - Bimanual Task Training and Constraint-Induced Movement Therapy in Hemiplegic Cerebral Palsy Children N/A
Completed NCT05490758 - Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP N/A