NCT04858646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 30, 2021

Last Update Submit

April 23, 2021

Conditions

Spastic Cerebral Palsy

Keywords

Cerebral palsyGross motor function measureAerobic exercises

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 months

Study Arms (2)

Aerobic exercises

EXPERIMENTAL

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

Other: Experimental( Group A ): Aerobic exercises

Conventional physical therapy

ACTIVE COMPARATOR

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.

Other: Conventional( Group B): Conventional Physical therapy

Interventions

Experimental( Group A ): Aerobic exercisesOTHER

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

Aerobic exercises
Conventional( Group B): Conventional Physical therapyOTHER

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

Conventional physical therapy

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with CP at GMFCS level I- III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 23525125BACKGROUND

  • 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.

    PMID: 26003063BACKGROUND

  • 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.

    PMID: 27900177BACKGROUND

  • 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.

    PMID: 25750868BACKGROUND

  • 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.

    PMID: 23034639BACKGROUND

  • 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.

    PMID: 24092902BACKGROUND

  • 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.

    PMID: 28602046BACKGROUND

  • 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.

    PMID: 31177250BACKGROUND

  • 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.

    PMID: 29557839BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tehreem Mukhtar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 26, 2021

Study Start

January 15, 2019

Primary Completion

June 20, 2019

Study Completion

June 30, 2019

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)