Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic
Primary Purpose
Spastic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Enriched Environment
Traditional Physcial Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Therapeutic Dosing, Enriched Environment
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
Sites / Locations
- The University of Lahore Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A
Group B
Arm Description
Intervention Given: Enriched Environment (age-appropriate) + NDT + Therapeutic Dosing
Traditional Physical Therapy consisting of NDT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05418192
Brief Title
Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic
Official Title
Effects of Therapeutic Dosing Through Enriched Environment on Gross Motor Function and Spasticity in Spastic Quadriplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Therapeutic Dosing, Enriched Environment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Intervention Given: Enriched Environment (age-appropriate) + NDT + Therapeutic Dosing
Arm Title
Group B
Arm Type
Other
Arm Description
Traditional Physical Therapy consisting of NDT
Intervention Type
Other
Intervention Name(s)
Enriched Environment
Intervention Description
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
Intervention Name(s)
Traditional Physcial Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gross Motor Function
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Spasticity
Description
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.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safa Saleem, DPT
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic
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