Clinical Trials Directory

Trials / Completed

CompletedNCT05418192

Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic

Effects of Therapeutic Dosing Through Enriched Environment on Gross Motor Function and Spasticity in Spastic Quadriplegic Cerebral Palsy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
82 (actual)
Sponsor
University of Lahore · Academic / Other
Sex
All
Age
7 Months – 5 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHEREnriched EnvironmentEnriched 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.
OTHERTraditional Physcial TherapyParticipants 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.

Timeline

Start date
2022-01-03
Primary completion
2022-09-30
Completion
2022-09-30
First posted
2022-06-14
Last updated
2023-01-17

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT05418192. Inclusion in this directory is not an endorsement.