NDT: Neurodevelopmental Therapy for Spastic Cerebral Palsy

Sponsor

University of Lahore (Other)

Overall Status

Completed

CT.gov ID

NCT05231538

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Spastic Diplegia, Spastic	Other: Neurodevelopmental therapy Other: Routine physical therapy	N/A

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

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned to one of two groups in parallel for the duration of the studyParticipants are assigned to one of two groups in parallel for the duration of the study

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessor was blind to treatment regimen administered to both groups

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 17, 2021

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Active Comparator: Routine Physical Therapy The control group underwent the exercises (stretching, passive range of motion, and active range of motion).	Other: Routine physical therapy stretching, passive range of motion, and active range of motion).

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Active Comparator: Routine Physical Therapy

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

Other: Routine physical therapy

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

Outcome Measures

Primary Outcome Measures

Gross Motor Function Scale (GMFS) [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
The Posture and Postural Ability Scale (PPAS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.