- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649501
Effect of PNF on Selective Motor Control and Balance in CP
Effects of Proprioceptive Neuromuscular Facilitation on Selective Motor Control of Lower Extremity and Balance in Children With Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A case study was conducted in 2021 to determine the effects of PNF training for improving lower limb coordination in 7 years old cerebral palsy child. After the intervention, significant improvement is seen in gait parameters, balance, and gross motor functional classification score.
A case report was conducted in 2020, to determine the effectiveness of PNF technique in improving lower extremity function in spastic diplegic cerebral palsied adolescent. Patient was treated with tone inhibitory and movement facilitatory techniques. There was significant change in balance and lower extremity function before and after the treatment.
There are multiple impairments in spastic cerebral palsy children; the inability to perform purposeful voluntary movements is a critical factor in determining functional ability of children. Since selective voluntary motor control is an important factor that must be achieved in cerebral palsy children, PNF may be considered as a technique to gain selective voluntary control and balance proving an important intervention for cerebral palsy children.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Pakistan Society for Rehabilitation of the Disabled (PSRD)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children diagnosed as spastic diplegic cerebral palsy
- Age between 5-12 years and both genders.
- Gross motor function level II and III according to gross motor functional classification scale (GMFCS).
- Spasticity range between 1 and 1+ grade according to modified ashworth scale
- Children who are able to follow simple verbal instructions
Exclusion Criteria:
- Children with uncontrolled epilepsy
- Children who show no cooperation
- Children receiving botulinum toxin injections or surgery no earlier than 6 months before project starts.
- Subjects with presence of shortening or deformities of lower limb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: proprioceptive neuromuscular facilitation techniques
Experimental group will receive proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional physical therapy.
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Proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional treatment for 40 minutes.
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Active Comparator: traditional physical therapy
this group will receive conventional therapy (ROMs, stretching, strengthening).
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Proprioceptive neuromuscular facilitation stretching which include hold-relax and contract-relax for 6 sec hold, 10 repetitions and 2 min rest in between, for 5 day/week for 4 weeks along with conventional treatment for 40 minutes.
Conventional therapy (ROMs, stretching, strengthening) of lower limbs for 40 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pediatric Berg Balance Scale
Time Frame: last one week
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The Pediatric Balance Scale (PBS), a modification of Berg's Balance Scale, was developed as a balance measure for school-age children with mild to moderate motor impairments.
It has 14 items with score 0-4.
The intra-class correlation coefficient (ICC) is 0.998 (18).
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last one week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Selective control assessment of lower extremity (SCALE)
Time Frame: last one week
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The SCALE tool was designed for clinical administration and scoring by healthcare professionals, to be used in less than 15 minutes without specialized equipment.
Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally.
One representative reciprocal movement that varies from the mass flexor/extensor patterns is chosen to assess SVMC for each joint.
Total score is 10 for each limb.
Intra-class correlation coefficient ranges from 0.88 to 0.91 (19).
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last one week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shabana Ashraf, Masters, Riphah International University
Publications and helpful links
General Publications
- Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480.
- Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Mutch L, Alberman E, Hagberg B, Kodama K, Perat MV. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992 Jun;34(6):547-51. doi: 10.1111/j.1469-8749.1992.tb11479.x. No abstract available.
- Tang-Wai R, Webster RI, Shevell MI. A clinical and etiologic profile of spastic diplegia. Pediatr Neurol. 2006 Mar;34(3):212-8. doi: 10.1016/j.pediatrneurol.2005.08.027.
- 15. Akalan E, Ertürk G, Önerge K, Evrendirek H, Karaca G. Investigation of the Relationship Between Selective Voluntary Motor Control and Static Balance in Cerebral Palsy. 2019.
- Franjoine MR, Darr N, Held SL, Kott K, Young BL. The performance of children developing typically on the pediatric balance scale. Pediatr Phys Ther. 2010 Winter;22(4):350-9. doi: 10.1097/PEP.0b013e3181f9d5eb.
- Balzer J, Marsico P, Mitteregger E, van der Linden ML, Mercer TH, van Hedel HJ. Construct validity and reliability of the Selective Control Assessment of the Lower Extremity in children with cerebral palsy. Dev Med Child Neurol. 2016 Feb;58(2):167-72. doi: 10.1111/dmcn.12805. Epub 2015 May 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/22/0725 Misbah Tahir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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