Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Effects of Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787210
• Other study ID #: REC/RCR & AHS/23/0704
• Status: Completed
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incidence of cerebral palsy is approximately 2 to 3 cases per 1000 live births around the world. In Cerebral palsy the lesion in the central nervous system frequently results in spasticity of various muscle groups. Spasticity is defined as a velocity dependent resistance to stretch. Spastic Cerebral palsy is caused by damage to the pyramidal parts of the brain. The children with spastic CP frequently experience problems with motor control, and balance which may lead to gait abnormalities. Because of motor weakness and poor voluntary motor control the children with spastic cerebral palsy develop crouch gait characterized by excessive hip and knee flexion and a slower walking speed, a shorter stride length, and more time spent in double support. This study will help in the quality of life in spastic cerebral palsy children. This will be a Randomized Controlled Trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 Children with Spastic CP will be randomly distributed into 2 groups. The Control Group (n=10) will be administered with the baseline treatment that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation 3 sessions per week for 8 weeks. The experimental group (n=10) will be administered with the strength training intervention along with baseline treatment, 3 sessions per week for 8 weeks. Gait parameters will be evaluated physically by measuring stride and step length and cadence. 5-meter stretch test for gait parameters. the energy expenditure will be calculated by measuring the physiological cost index that includes measuring the speed of walking and resulting increase in heart rate. Data will be analyzed by using SPSS version 26.0 and necessary analysis will be done after checking the normality of Data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 30, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diplegic Cerebral palsy
• (GMFC) level 1 and 2
• Able to follow verbal direction for standard testing

Exclusion Criteria:

• Orthopedic and Neurosurgery in last 12 months
• Children with any associated medical condition
• Children with Botox therapy in last six months

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Conventiional Physiotherapy
The Control group will be administered with Conventional Physiotherapy that Includes 5 minutes of trunk control training, 5 minutes walking in the hall with And without the therapist assistance, walker or crutches, and finally 5 minutes of Breathing exercises for Relaxation
• Quadriceps Strength Training
The experimental group will be administered with the same baseline treatment such as 5 minutes of trunk control training, 5 minutes walking in the hall with or without the therapist assistance, walker or crutches and 5 minutes breathing exercises for relaxation. In addition, they were given strength training protocol intervention other than the baseline treatment. This strength training protocol include progressive resistance training program in which we gave leg lift (knee flexion and extension), Hip rotations, seated marching and the quadriceps muscles would be specifically targeted.

Locations

Country	Name	City	State
Pakistan	Al-noor Special Children School	Multan	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Bhilwade1 DAH, DSSGP. Effect of Spasticity on Gait Parameters and Physiological Cost Index in Patients with Spastic Cerebral Palsy. 2020

Merino-Andres J, Garcia de Mateos-Lopez A, Damiano DL, Sanchez-Sierra A. Effect of muscle strength training in children and adolescents with spastic cerebral palsy: A systematic review and meta-analysis. Clin Rehabil. 2022 Jan;36(1):4-14. doi: 10.1177/02692155211040199. Epub 2021 Aug 18. — View Citation

Valadao P, Piitulainen H, Haapala EA, Parviainen T, Avela J, Finni T. Exercise intervention protocol in children and young adults with cerebral palsy: the effects of strength, flexibility and gait training on physical performance, neuromuscular mechanisms and cardiometabolic risk factors (EXECP). BMC Sports Sci Med Rehabil. 2021 Feb 26;13(1):17. doi: 10.1186/s13102-021-00242-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gait parameters	5-meter stretch test for gait parameters that include: the participant to walk barefoot with their normal speed on a 5-mt stretch of plain white paper with inked foot within a fixed time and it was recorded using a stopwatch. Prior to data collection, all participants had an opportunity to practice walking, as first few steps were discarded. The gait parameters analyzed will be step length, stride length, cadence and gait speed	Baseline and 8th week
Primary	Change in ENERGY EXPENDITURE	The Physiological Cost Index was introduced by MacGregor and is used to check energy expenditure. it is calculated by estimating the speed of walking and the increase in heart rate after the child has walked a specified distance at a self-selected pace. .We calculate the physiological cost index by Formula for calculation PCI is: PCI (beats/min) = Walking heart rate; - Resting heart rate / walking speed (m/min)	Baseline and 8th week