Task Oriented Activities Based on NDT Therapy Principles

November 9, 2023 updated by: Riphah International University

Effects of Task Oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control and Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy

Cerebral palsy (CP) is one of the primary causes of disability effecting majority of pediatric population. Cerebral Palsy is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. The worldwide incidence of cerebral palsy is it affects three to four individuals out of 1000 individuals in the general population. Cerebral palsy has different types depending upon the severity of disease or the area of the body it is affecting. Amongst the different types of CP, spastic diplegia is the most common type which mainly affects the lower extremities and lesser extent to upper extremities. It mainly affects functional performance and gait.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted on 20 subjects which would be equally divided into experimental and control groups. Trunk control measurement scale (TCMS) and quality of upper extremity skills test (QUEST) will be the tools used in this study. Pre and post values of the effects of intervention will be evaluated. The significance of this study is that it will help us how to improve trunk control and upper extremity function in spastic dipegic children. Data will be analyzed using SPSS 22.0. Mean and standard deviation will be calculated. Appropriate statistical test will be used after checking normality of data.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Children with spastic diplegic cerebral palsy with age between 6 to 12 years.

    • Children with spastic diplegic cerebral palsy who are able to follow verbal commands.
    • Children with spastic diplegic cerebral palsy having level II or III of gross motor function classification system.

Exclusion Criteria:

  • • Children who are uncooperative and having neurological deficit.

    • Children with hearing deficit.
    • Children with epilepsy.
    • Children with cardiac anomalies which effect exercise tolerance.
    • Children having less than 6-month post-orthopedic surgery.
    • Children having less than 6-month post-botulinum toxin injection (BOTOX).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: neurodevelopmental therapy group
in this group patients wil be treated with task oriented activities using neurodevelopmental therapy principles. This group will receive therapy session for 1 hour 6 days a week and for 8 weeks. total sessions will be 48. this group will receive task oriented neurodevelopmental therapy for 30 mins and next 30 mins it will receive conventional treatment.
Other: Neurodevelopmental therapy treatment
The group will receive NDT therapy
Experimental: conventional physiotherapy group
in this group patients will be treated with conventional physiotherpy treatment protocol. this group will receive therapy session for one hour, 6 times in a week for 8 weeks. total therapy sessions will be 48. this group will receive 30 mins conventional physiotherapy treatment and 30 mins task oriented neurodevelopmental therapy.
Other: conventional physiotherapy
conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The trunk control measurement scale
Time Frame: 8 weeks
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quality of Upper Extremity Skills Test (QUEST)
Time Frame: 8 weeks
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Ayesha tul Fatima, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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