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

University of Lahore

Status: Completed

Conditions: Spastic Cerebral Palsy

Treatments: Other: Enriched Environment; Other: Traditional Physcial Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05418192

REC-UOL-/74-03/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 7 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Group A

Experimental group

Description:

Intervention Given: Enriched Environment (age-appropriate) + NDT + Therapeutic Dosing

Treatment:

Other: Enriched Environment

Group B

Other group

Description:

Traditional Physical Therapy consisting of NDT

Treatment:

Other: Traditional Physcial Therapy