NCT05903729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

June 6, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • The trunk control measurement scale

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

    8 weeks

Secondary Outcomes (1)

  • The Quality of Upper Extremity Skills Test (QUEST)

    8 weeks

Study Arms (2)

neurodevelopmental therapy group

EXPERIMENTAL

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

conventional physiotherapy group

EXPERIMENTAL

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

Interventions

The group will receive NDT therapy

neurodevelopmental therapy group

conventional physiotherapy

conventional physiotherapy group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 31649770BACKGROUND
  • 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.

    PMID: 37021364BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ayesha tul Fatima, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatmaent.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

May 23, 2023

Primary Completion

August 31, 2023

Study Completion

September 15, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations