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

NCT05418192 | Completed

• 1 other identifier: REC-UOL-/74-03/2022
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Cerebral Palsy

Keywords

Therapeutic Dosing; Enriched Environment

Outcome Measures

Primary Outcomes (1)

• 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 1. = initiates 2. = partially completes 3. = completes Higher scores mean better outcome whereas low scores show little to no improvement in gross motor function.

  5 months

Secondary Outcomes (1)

• Spasticity

  5 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Enriched Environment

Group B

OTHER

Traditional Physical Therapy consisting of NDT

Other: Traditional Physcial Therapy

Interventions

Enriched Environment 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 A

Traditional Physcial Therapy 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.

Group B

Eligibility Criteria

• Age: 7 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• History of fits
• Medications
• Dislocation and fracture
• Visual/Auditory Impairment
• Patients taking therapy from multiple places

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Safa Saleem, DPT

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 14, 2022
• Study Start: January 3, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)