Back to resultsEffects of Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive Training
Routine Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring : Spastic Quadriplegia, Cerebral palsy, Proprioceptive training, Somatosensory input
Eligibility Criteria
Inclusion Criteria:
- Children with the diagnosis of Cerebral Palsy (Spastic quadriplegia)
- Ages of 1 to 5 years
- Both males and females
- Alert and responsive to verbal and non-verbal commands
- Modified Ashworth Sale grade 1 to 2
- Gross Motor Function Classification System level 1V and V
Exclusion Criteria:
- Children under the botox treatment for tone management (botulinum injections)
- Diagnosed with any disease other than spastic quadriplegic cerebral palsy i.e. congenital heart defects, epilepsy, recurrent pneumonia, skin infections etc.
- Children underwent any surgery i.e. tenotomy (tendon release), recent heart surgery,
- Recent fracture and subluxation/dislocation due to fall or poor handling
- Any contracture or deformity on upper extremities, lower extremities and spine i.e. flexion contractures, club foot, scoliosis
Sites / Locations
- The University of Lahore Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) Proprioceptive Input- age appropriate (Pushups Static quadruped, squat sitting, trampoline, hopping etc. With weights and splints for joint to joint approximation)
NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate)
Outcomes
Primary Outcome Measures
Gross Motor Function
Gross Motor Function Classification System (GMFCS) is a 5-level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities. Higher scores indicate better improvement in gross motor functions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05436847
Brief Title
Effects of Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP
Official Title
Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Gross Motor Function in Children With Spastic Quadriplegic Cerebral Palsy: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 10, 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
The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children
Detailed Description
Proprioception plays an important role in the correct execution of efferent motor performance as 70% of cerebral palsy population have deficit in receiving somatosensory signals3. Tradition physical therapy exercises including strengthening followed by stretching etc. should be reviewed and the therapy must be more oriented to overall individual growth and development31. There is a need to push the cerebral palsy population to be exercised with proprioceptive stimulation for their maximum participation in the activities of daily life including both personal and social aspects. The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
: Spastic Quadriplegia, Cerebral palsy, Proprioceptive training, Somatosensory input
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate) Proprioceptive Input- age appropriate (Pushups Static quadruped, squat sitting, trampoline, hopping etc. With weights and splints for joint to joint approximation)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate)
Intervention Type
Other
Intervention Name(s)
Proprioceptive Training
Intervention Description
Proprioceptive Training using increased joint to joint approximation through ankle weights and joint splints.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
Neurodevelopmental treatment- age appropriate
Primary Outcome Measure Information:
Title
Gross Motor Function
Description
Gross Motor Function Classification System (GMFCS) is a 5-level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities. Higher scores indicate better improvement in gross motor functions.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with the diagnosis of Cerebral Palsy (Spastic quadriplegia)
Ages of 1 to 5 years
Both males and females
Alert and responsive to verbal and non-verbal commands
Modified Ashworth Sale grade 1 to 2
Gross Motor Function Classification System level 1V and V
Exclusion Criteria:
Children under the botox treatment for tone management (botulinum injections)
Diagnosed with any disease other than spastic quadriplegic cerebral palsy i.e. congenital heart defects, epilepsy, recurrent pneumonia, skin infections etc.
Children underwent any surgery i.e. tenotomy (tendon release), recent heart surgery,
Recent fracture and subluxation/dislocation due to fall or poor handling
Any contracture or deformity on upper extremities, lower extremities and spine i.e. flexion contractures, club foot, scoliosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Jawad, MSPTN
Organizational Affiliation
The 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 Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP
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