Neurodevelopmental Therapy for Spastic Cerebral Palsy

NCT ID: NCT05231538

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2021-12-31

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.

Conditions

Cerebral Palsy; Spastic; Diplegia, Spastic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurodevelopmental Therapy

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.

Group Type: EXPERIMENTAL

Neurodevelopmental therapy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Routine physical therapy

Intervention Type: OTHER

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

Interventions

Neurodevelopmental therapy

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.

Intervention Type: OTHER

Routine physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Abdullah Khalid Khan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdullah Khalid khan, MSNPT

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB-UOL-FAHS/882/2021

Identifier Type: -

Identifier Source: org_study_id