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

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.

Study Overview

• Status: Completed
• Conditions: Spastic Cerebral Palsy
• Intervention / Treatment: Other: Enriched Environment; Other: Traditional Physcial Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • The University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Intervention Given: Enriched Environment (age-appropriate) + NDT + Therapeutic Dosing	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.
Other: Group B; Traditional Physical Therapy consisting of NDT	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: Safa Saleem, DPT, University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Enriched Environment; Therapeutic Dosing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: REC-UOL-/74-03/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No