- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436847
Effects of Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP
June 23, 2022 updated by: University of Lahore
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- The University of Lahore Teaching Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
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)
|
Proprioceptive Training using increased joint to joint approximation through ankle weights and joint splints.
|
|
Active Comparator: Group B
NDT- age appropriate Transitions (age appropriate) Milestones training (age appropriate)
|
Neurodevelopmental treatment- age appropriate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross Motor Function
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Jawad, MSPTN, The University of Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
June 10, 2022
Study Registration Dates
First Submitted
June 23, 2022
First Submitted That Met QC Criteria
June 23, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
June 29, 2022
Last Update Submitted That Met QC Criteria
June 23, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/831-VI/2021
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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