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Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental( Group A ): Aerobic exercises
Conventional( Group B): Conventional Physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Cerebral palsy, Gross motor function measure, Aerobic exercises

Eligibility Criteria

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

Inclusion Criteria:

  • Children with CP at GMFCS level I- III

Exclusion Criteria:

  • Botulinum toxin-A- injection in lower limb last 6 months
  • <0° dorsiflexion in ankle
  • Unable to cooperate and follow instructions
  • Children with progressive brain disorder

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercises

Conventional physical therapy

Arm Description

Subjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities

Traditional physical therapy The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes. Treatment duration for both groups will be 30 minutes. Each subject received total 30 sessions of the treatment, with 5 treatment sessions per week for 6 weeks. Post treatment reading were collected after end of 6th weeks.

Outcomes

Primary Outcome Measures

Gross motor function measure (GMFM-66 and 88)
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running).

Secondary Outcome Measures

Full Information

First Posted
March 30, 2021
Last Updated
April 23, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04858646
Brief Title
Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy
Official Title
Effects of Aerobic Exercises on Gross Motor Function in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

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 aim of this research is to find the effects of aerobic exercise on gross motor function in cerebral palsy patients. Quasai experimental study done at Noor Zainab Rehabilitation center, Lahore. The sample size was 34. The subjects were divided in two groups, 17 subjects with aerobic exercise 17 children with conventional treatment. Sampling technique applied was purposive non probability sampling. Only 7-12 years individuals with GMFCS level I- III were included. Tools used in the study were Gross motor function measure (GMFM-66 and 88) .Data was be analyzed through SPSS 21.
Detailed Description
Cerebral palsy" an umbrella term for a group of irreversible and non-progressive abnormalities of the fetal or neonatal brain, this can lead to disorders of movement and posture. National Institute for Health and Care Excellence (NICE) states that, it is the most common cause of physical disability in children and young people in the developing world. CP is condition with multiple causes; multiple clinical types; multiple associated developmental pathologies, such as intellectual disability, autism, epilepsy, and visual impairment; and more recently multiple rare pathogenic genetic variations Motor disability in cerebral palsy is related with sitting, standing, walking and running appears as the main symptom in children with CP, the assessment and management of CP have focused on gross motor function. The Gross Motor Function Measure (GMFM) is designed by Russell et al. in 1993 is used to measure the level of motor development and changes of gross motor function in a standardized environment in children with CP. GMFM-66 is comprised of a subset of the 88 items identified as contributing to the measure of gross motor function in children with CP, ranging from 0 (lowest motor function) to 100 (highest motor function). Cardiorespiratory endurance is an integral component of physical fitness and has been identified as the most important fitness component associated with health and mortality. In clinical practice, rebound is usually offered as a 20 minute session, once per week for 6 weeks. Typical rebound therapy programs target gross motor skill development, such as balance while sitting, kneeling, standing and walking; functional transfers such as rolling and sit to stand; aerobic activity such as jumping. It is theorized that using a trampoline improves muscle tone, posture, balance, kinesthetic awareness, movement, body awareness, and communication. Aerobic exercise may improve activity as indicated by motor function but does not appear to improve gait speed, walking endurance, participation or aerobic fitness among children with CP in the short or intermediate term. Researcher to conduct a study on effects of robot assisted gait training in CP children, collect data from 14 consecutive children affected by CP, each session of 60 minutes, 20 daily sessions for 5 days per week. Saeid Fatorehchy et al. in 2019 conducted an RCT, this study was to evaluate the effects of aquatic therapy in cerebral palsy patients. Six children with average age of 7 years 4 months are included. Each sessions lasted for 50 minutes, comprising 10 minutes of warm up and stretching and 40 minutes of walking in pool at different at different water depths. Maria A. Fragala-Pinkham et al. stated that participation in routine physical activity is important for health promotion and prevention of chronic health condition. Participating in sports and active recreation can be beneficial on several levels for children and adults with CP. At the body function and structure level of the ICF, improvement in fitness and endurance have been documented for children and young with CP. Sports equipment that can be use are cycling, swimming, sketching and outdoor active recreation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Cerebral palsy, Gross motor function measure, Aerobic exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercises
Arm Type
Experimental
Arm Description
Subjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Traditional physical therapy The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes. Treatment duration for both groups will be 30 minutes. Each subject received total 30 sessions of the treatment, with 5 treatment sessions per week for 6 weeks. Post treatment reading were collected after end of 6th weeks.
Intervention Type
Other
Intervention Name(s)
Experimental( Group A ): Aerobic exercises
Intervention Description
Subjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities
Intervention Type
Other
Intervention Name(s)
Conventional( Group B): Conventional Physical therapy
Intervention Description
The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes.Treatment duration for both groups will be 30 minutes. Each subject received total30sessions of the treatment, with 5 treatment sessions per week for 6 weeks
Primary Outcome Measure Information:
Title
Gross motor function measure (GMFM-66 and 88)
Description
The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) The scoring system of the GMFM is a four-point scale divided into five categories (lying and rolling; sitting; crawling and kneeling; standing; walking, running).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with CP at GMFCS level I- III Exclusion Criteria: Botulinum toxin-A- injection in lower limb last 6 months <0° dorsiflexion in ankle Unable to cooperate and follow instructions Children with progressive brain disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tehreem Mukhtar, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23525125
Citation
Kwon TG, Yi SH, Kim TW, Chang HJ, Kwon JY. Relationship between gross motor function and daily functional skill in children with cerebral palsy. Ann Rehabil Med. 2013 Feb;37(1):41-9. doi: 10.5535/arm.2013.37.1.41. Epub 2013 Feb 28. Erratum In: Ann Rehabil Med. 2013 Oct;37(5):756.
Results Reference
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PubMed Identifier
26003063
Citation
MacLennan AH, Thompson SC, Gecz J. Cerebral palsy: causes, pathways, and the role of genetic variants. Am J Obstet Gynecol. 2015 Dec;213(6):779-88. doi: 10.1016/j.ajog.2015.05.034. Epub 2015 May 21.
Results Reference
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PubMed Identifier
27900177
Citation
Lauglo R, Vik T, Lamvik T, Stensvold D, Finbraten AK, Moholdt T. High-intensity interval training to improve fitness in children with cerebral palsy. BMJ Open Sport Exerc Med. 2016 May 9;2(1):e000111. doi: 10.1136/bmjsem-2016-000111. eCollection 2016.
Results Reference
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PubMed Identifier
25750868
Citation
Kim OY, Shin YK, Yoon YK, Ko EJ, Cho SR. The effect of treadmill exercise on gait efficiency during overground walking in adults with cerebral palsy. Ann Rehabil Med. 2015 Feb;39(1):25-31. doi: 10.5535/arm.2015.39.1.25. Epub 2015 Feb 28.
Results Reference
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PubMed Identifier
23034639
Citation
Balemans AC, Van Wely L, De Heer SJ, Van den Brink J, De Koning JJ, Becher JG, Dallmeijer AJ. Maximal aerobic and anaerobic exercise responses in children with cerebral palsy. Med Sci Sports Exerc. 2013 Mar;45(3):561-8. doi: 10.1249/MSS.0b013e3182732b2f.
Results Reference
background
PubMed Identifier
24092902
Citation
Verschuren O, Darrah J, Novak I, Ketelaar M, Wiart L. Health-enhancing physical activity in children with cerebral palsy: more of the same is not enough. Phys Ther. 2014 Feb;94(2):297-305. doi: 10.2522/ptj.20130214. Epub 2013 Oct 3.
Results Reference
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PubMed Identifier
28602046
Citation
Ryan JM, Cassidy EE, Noorduyn SG, O'Connell NE. Exercise interventions for cerebral palsy. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD011660. doi: 10.1002/14651858.CD011660.pub2.
Results Reference
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PubMed Identifier
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Citation
Digiacomo F, Tamburin S, Tebaldi S, Pezzani M, Tagliafierro M, Casale R, Bartolo M. Improvement of motor performance in children with cerebral palsy treated with exoskeleton robotic training: A retrospective explorative analysis. Restor Neurol Neurosci. 2019;37(3):239-244. doi: 10.3233/RNN-180897. Erratum In: Restor Neurol Neurosci. 2020;38(2):185.
Results Reference
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PubMed Identifier
29557839
Citation
Gillett JG, Lichtwark GA, Boyd RN, Barber LA. Functional Anaerobic and Strength Training in Young Adults with Cerebral Palsy. Med Sci Sports Exerc. 2018 Aug;50(8):1549-1557. doi: 10.1249/MSS.0000000000001614.
Results Reference
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Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy

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