search
Back to results

Task Oriented Activities Based on NDT Therapy Principles

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neurodevelopmental therapy treatment
conventional physiotherapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring CP, NDT therapy, task-oriented training, trunk control

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Riphah International UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

neurodevelopmental therapy group

conventional physiotherapy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The trunk control measurement scale
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy.

Secondary Outcome Measures

The Quality of Upper Extremity Skills Test (QUEST)
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy.

Full Information

First Posted
June 6, 2023
Last Updated
June 13, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05903729
Brief Title
Task Oriented Activities Based on NDT Therapy Principles
Official Title
Effects of Task Oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control and Upper Extremity Function in Children With Spastic Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
CP, NDT therapy, task-oriented training, trunk control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a randomized control trial, used to compare conventional physiotherapt and neurodevelopmental therapy approaches on trunk control and upper extremity function in spastic diplegic cerebral palsy patients. subjects with spastic diplegic cerebral palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique.
Masking
Participant
Masking Description
participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatmaent.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neurodevelopmental therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional physiotherapy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental therapy treatment
Intervention Description
The group will receive NDT therapy
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
conventional physiotherapy
Primary Outcome Measure Information:
Title
The trunk control measurement scale
Description
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Quality of Upper Extremity Skills Test (QUEST)
Description
The Quality of Upper Extremity Skills Test is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
+9233224390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Asif Javed, MS
Phone
03104174377
Email
a.javed@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha tul Fatima, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31649770
Citation
Sah AK, Balaji GK, Agrahara S. Effects of Task-oriented Activities Based on Neurodevelopmental Therapy Principles on Trunk Control, Balance, and Gross Motor Function in Children with Spastic Diplegic Cerebral Palsy: A Single-blinded Randomized Clinical Trial. J Pediatr Neurosci. 2019 Jul-Sep;14(3):120-126. doi: 10.4103/jpn.JPN_35_19. Epub 2019 Sep 27.
Results Reference
background
PubMed Identifier
37021364
Citation
Talgeri AJ, Nayak A, Karnad SD, Jain P, Tedla JS, Reddy RS, Sangadala DR. Effect of Trunk Targeted Interventions on Functional Outcomes in Children with Cerebral Palsy- A Systematic Review. Dev Neurorehabil. 2023 Apr;26(3):193-205. doi: 10.1080/17518423.2023.2193265. Epub 2023 Apr 5.
Results Reference
background

Learn more about this trial

Task Oriented Activities Based on NDT Therapy Principles

We'll reach out to this number within 24 hrs