Aerobic Exercises and Gross Motor Function in Spastic Cerebral Palsy

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04858646
Collaborator
(none)
34
1
2
5.5
6.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental( Group A ): Aerobic exercises
  • Other: Conventional( Group B): Conventional Physical therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Aerobic Exercises on Gross Motor Function in Children With Spastic Cerebral Palsy
Actual Study Start Date :
Jan 15, 2019
Actual Primary Completion Date :
Jun 20, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: 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

Active Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Gross motor function measure (GMFM-66 and 88) [3 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riphah International University Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Tehreem Mukhtar, MS, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04858646
Other Study ID Numbers:
  • REC/Lhr/19/2021 Hira Nawaz
First Posted:
Apr 26, 2021
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2021