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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05418192
Other study ID # REC-UOL-/74-03/2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2022
Est. completion date September 30, 2022

Study information

Verified date January 2023
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study focuses on how enriched environment along with the traditional physical therapy improves the gross motor function in spastic quadriplegic cerebral palsy children. And how much dosing is required to gain that clinically significant improvement.


Description:

There is still a blurred area regarding dosage parameter in cerebral palsy rehabilitation. This study is focused primarily on the fact that level appropriate selection of time, type, frequency, and intensity of intervention (sensory and motor) plays a very vital role in developing gross motor functions. Secondly it is very important to establish the impact of enriched environmental inputs and foster parent capacity as an early intervention taking into account cerebral palsy (CP) specific positioning and handling along with level appropriate sensory inputs.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Months to 5 Years
Eligibility Inclusion Criteria: Age Group between 7 months to 5 years. - Spastic Quadriplegia - Gross Motor Function Classification System (GMFCS) level IV and V - Modified Ashworth Scale (MAS): level 2 - Both Gender Exclusion Criteria: - History of fits - Medications - Dislocation and fracture - Visual/Auditory Impairment - Patients taking therapy from multiple places

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Enriched Environment
Enriched Environment (EE) consisted of motor and sensory enriched play environment to promote participant's self-generated movements, exploration and task success. EE also included positioning in a graded manner. Visual stimulus and level appropriate vestibular stimulus was also given. Dosing of positioning and sensory inputs was done throughout the therapy. Primary Intervention will be given for 20 to 25 minutes intermittently for period of 4-5 hours a day, 5 days a week for 24 weeks.
Traditional Physcial Therapy
Participants of this group received traditional physical therapy based NDT. No additional dosing guidance was given to this group. No home program was specifically assigned to this group. No specific environmental modifications were made for this group.

Locations

Country Name City State
Pakistan The University of Lahore Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gross Motor Function To check the improvement in gross motor function on Gross Motor Functional Measure scale of spastic quadriplegic cerebral palsy children. The scoring system of this scale is divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping. The scoring is done on four points: 0=does not initiate
= initiates
= partially completes
= completes Higher scores mean better outcome whereas low scores show little to no improvement in gross motor function.
5 months
Secondary Spasticity To check the improvement in spasticity on Modified Ashworth Scale scale in spastic quadriplegic cerebral palsy children. The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. 5 months
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