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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventiional Physiotherapy
Quadriceps Strength Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Al-noor Special Children SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Strength

Arm Description

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05787210
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Title
Strength
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Conventiional Physiotherapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Quadriceps Strength Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Gait parameters
Description
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
Time Frame
Baseline and 8th week
Title
Change in ENERGY EXPENDITURE
Description
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)
Time Frame
Baseline and 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Ph.D
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Fareeha Kausar, PP-DPT
Phone
03216758180
Email
fareeha.kausar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-noor Special Children School
City
Multan
State/Province
Punjab
ZIP/Postal Code
59300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Phone
03216758180
Email
fareeha.kausar@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Aliena Azam, MSPT (Pead)

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33637124
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.
Results Reference
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Citation
Bhilwade1 DAH, DSSGP. Effect of Spasticity on Gait Parameters and Physiological Cost Index in Patients with Spastic Cerebral Palsy. 2020
Results Reference
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PubMed Identifier
34407619
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.
Results Reference
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Quadriceps Strength Training on Gait Parameters and Energy Expenditure in Children With Spastic Cerebral Palsy

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