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Completed

NCT Number: NCT05231538

Neurodevelopmental Therapy for Spastic Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Diplegia, Spastic Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurodevelopmental therapy

Other

NDT is a hands-on, 'problem solving approach'. It is used in the management and treatment of children who have disorders of function, movement or postural control because of damage in their central nervous system.

Routine physical therapy

Other

stretching, passive range of motion, and active range of motion).

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Acronym: NDT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2022
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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