Neurodevelopmental Therapy for Spastic Cerebral Palsy

NCT05231538 | Completed

• 1 other identifier: IRB-UOL-FAHS/882/2021
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Spastic; Diplegia, Spastic

Keywords

Neurodevelopmental therapy; NDT; Spastic cerebral palsy; Physical Therapy; Rehabilitation; Neurorehabilitation

Outcome Measures

Primary Outcomes (2)

• Gross Motor Function Scale (GMFS)

  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

  12 weeks

• The Posture and Postural Ability Scale (PPAS)

  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

  12 weeks

Study Arms (2)

Neurodevelopmental Therapy

EXPERIMENTAL

The treatment group received neurodevelopment treatment lasting for 3 months (3sessions per week). Additionally, for this study, the NDT programme included passive stretching of the lower limb muscles (e.g. hamstrings, gastrocsoleus), followed by techniques of reducing spasticity and facilitating more normal patterns of movement while working on motor functions. In each session, exercises included patients sustaining themselves on their forearms and hands, sitting, crawling, semi-kneeling, and in standing positions supported by the Physical therapist until tone reduction achieved. Balance and corrective reactions were developed by using a CP ball and tilt board.

Other: Neurodevelopmental therapy

Routine Physical Therapy

ACTIVE COMPARATOR

The control group underwent the exercises (stretching, passive range of motion, and active range of motion).

Other: Routine physical therapy

Interventions

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.

Neurodevelopmental Therapy

Routine physical therapy OTHER

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

Routine Physical Therapy

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdullah Khalid khan, MSNPT

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor was blind to treatment regimen administered to both groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: February 9, 2022
• Study Start: June 17, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)