Task Oriented Activities Based on NDT Therapy Principles

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05903729

Collaborator

(none)

Enrollment

Location

Arms

3.8

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Neurodevelopmental therapy treatment Other: conventional physiotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Participant)

Masking Description:

participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatmaent.

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The trunk control measurement scale [8 weeks]
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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riphah International University	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05903729

Other Study ID Numbers:

REC/RCR & AHS/23/0711

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

CP, NDT therapy, task-oriented training, trunk control

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Jun 15, 2023