Task Oriented Activities Based on NDT Therapy Principles

NCT ID: NCT05903729

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2023-09-15

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Neurodevelopmental therapy treatment

Intervention Type OTHER

The group will receive NDT therapy

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.

Group Type EXPERIMENTAL

conventional physiotherapy

Intervention Type OTHER

conventional physiotherapy

Interventions

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Neurodevelopmental therapy treatment

The group will receive NDT therapy

Intervention Type OTHER

conventional physiotherapy

conventional physiotherapy

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayesha tul Fatima, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 31649770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37021364 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0711

Identifier Type: -

Identifier Source: org_study_id

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