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

NCT ID: NCT05418192

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-09-30

Brief 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

Spastic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Enriched Environment

Intervention Type: OTHER

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.

Group B

Traditional Physical Therapy consisting of NDT

Group Type: OTHER

Traditional Physcial Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Safa Saleem, DPT

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC-UOL-/74-03/2022

Identifier Type: -

Identifier Source: org_study_id