Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy

NCT ID: NCT04858646

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Spastic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic exercises

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

Group Type EXPERIMENTAL

Experimental( Group A ): Aerobic exercises

Intervention Type OTHER

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

Conventional physical therapy

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.

Group Type ACTIVE_COMPARATOR

Conventional( Group B): Conventional Physical therapy

Intervention Type OTHER

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

Interventions

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Experimental( Group A ): Aerobic exercises

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

Conventional( Group B): Conventional 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 total30sessions of the treatment, with 5 treatment sessions per week for 6 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tehreem Mukhtar, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 23525125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26003063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27900177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25750868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23034639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24092902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28602046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31177250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29557839 (View on PubMed)

Other Identifiers

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REC/Lhr/19/2021 Hira Nawaz

Identifier Type: -

Identifier Source: org_study_id

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