Effects of Dosing and Environment on Gross Motor and Spasticity in Spastic Quadriplegic
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- Gross Motor Function [5 months]
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 [5 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Age Group between 7 months to 5 years.
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Spastic Quadriplegia
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Gross Motor Function Classification System (GMFCS) level IV and V
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Modified Ashworth Scale (MAS): level 2
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Both Gender
Exclusion Criteria:
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History of fits
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Medications
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Dislocation and fracture
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Visual/Auditory Impairment
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Patients taking therapy from multiple places
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Lahore Teaching Hospital | Lahore | Punjab | Pakistan | 54000 |
Sponsors and Collaborators
- University of Lahore
Investigators
- Principal Investigator: Safa Saleem, DPT, University of Lahore
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REC-UOL-/74-03/2022