Clinical trial NCT05787210: Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy
Official title: Effects of Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Gait parameters
timeFrame: Baseline and 8th week
measure: Change in ENERGY EXPENDITURE
timeFrame: Baseline and 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Al-noor Special Children School
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fareeha Kausar, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Bhilwade1 DAH, DSSGP. Effect of Spasticity on Gait Parameters and Physiological Cost Index in Patients with Spastic Cerebral Palsy. 2020
citation: 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.