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Clinical Trials/NCT05231538
NCT05231538CompletedNot Applicable

Effects of Neurodevelopment Therapy on Gross Motor Function and Postural Control in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial

University of Lahore2 sites in 1 country66 target enrollmentStarted: June 17, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
66
Locations
2
Primary Endpoint
The Posture and Postural Ability Scale (PPAS)

Study Overview

Brief Summary

This study was conducted to find out the Effects of Neurodevelopment therapy (a rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in Children with Spastic Cerebral Palsy. To investigate either there was a significant difference between the effects of neurodevelopment therapy and routine physical therapy on gross motor function and postural control in children with Spastic Cerebral Palsy.

Detailed Description

A randomized controlled trial was conducted at Department of pediatric rehabilitation, Sher e Rabbani Hospital, Sheikhupura. Sample size was 66 and purposive sampling technique was adopted to collect data. Sample selection was completely based on inclusion and exclusion criteria. A diagnosed Spastic Cerebral Palsy patient aged 2-6 years with no other severe abnormalities such as seizure were recruited. While patients with mental retardation or undergone medical procedures likely to affect motor function such as botulinum toxin injections, orthopedic remedial surgery were excluded. Data was collected at baseline, 4th, 8th and 12th week of the treatment sessions. Gross motor function measure scale (GMFM-88) and posture and postural ability scale (PPAS) were used as data collection tools.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Assessor was blind to treatment regimen administered to both groups

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • • A diagnosed Spastic Cerebral Palsy (patient's diagnosis of CP confirmed by an expert pediatrician neurologist)
  • Spastic CP
  • No other severe abnormalities such as seizure
  • Aged 2-6 years
  • Both Genders

Exclusion Criteria

  • Medical procedures likely to affect motor function such as botulinum toxin injections
  • Orthopedic remedial surgery
  • Mental retardation, or a learning disability.

Outcomes

Primary Outcomes

The Posture and Postural Ability Scale (PPAS)

Time Frame: 12 weeks

The Posture and Postural Ability Scale (PPAS) is a 7-point ordinal scale for the assessment of postural ability in standing, sitting, supine and prone. There are six items for assessment of quality of posture in the frontal plane and another six items in the sagittal plane

Gross Motor Function Scale (GMFS)

Time Frame: 12 weeks

The Gross motor function scale (GMFS) is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Lahore
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdullah Khalid Khan

Principal Investigator

University of Lahore

Study Sites (2)

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