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Neurodevelopmental Therapy for Spastic Cerebral Palsy (NDT)

Primary Purpose

Cerebral Palsy, Spastic, Diplegia, Spastic

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neurodevelopmental therapy
Routine physical therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Neurodevelopmental therapy, NDT, Spastic cerebral palsy, Physical Therapy, Rehabilitation, Neurorehabilitation

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • The University of Lahore Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neurodevelopmental Therapy

Routine Physical Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2022
Last Updated
January 29, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05231538
Brief Title
Neurodevelopmental Therapy for Spastic Cerebral Palsy
Acronym
NDT
Official Title
Effects of Neurodevelopment Therapy on Gross Motor Function and Postural Control in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Diplegia, Spastic
Keywords
Neurodevelopmental therapy, NDT, Spastic cerebral palsy, Physical Therapy, Rehabilitation, Neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study
Masking
Outcomes Assessor
Masking Description
Assessor was blind to treatment regimen administered to both groups
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodevelopmental Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Physical Therapy
Arm Type
Active Comparator
Arm Description
The control group underwent the exercises (stretching, passive range of motion, and active range of motion).
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental therapy
Intervention Description
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
Intervention Name(s)
Routine physical therapy
Intervention Description
stretching, passive range of motion, and active range of motion).
Primary Outcome Measure Information:
Title
Gross Motor Function Scale (GMFS)
Description
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
Time Frame
12 weeks
Title
The Posture and Postural Ability Scale (PPAS)
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Khalid khan, MSNPT
Organizational Affiliation
The university of lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurodevelopmental Therapy for Spastic Cerebral Palsy

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