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Effect of PNF on Selective Motor Control and Balance in CP

Primary Purpose

CP (Cerebral Palsy)

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive neuromuscular facilitation techniques.
Traditional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CP (Cerebral Palsy) focused on measuring Proprioceptive neuromuscular techniques, Selective voluntary motor control, Balance

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pakistan Society for Rehabilitation of the Disabled (PSRD)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

proprioceptive neuromuscular facilitation techniques

traditional physical therapy

Arm Description

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.

this group will receive conventional therapy (ROMs, stretching, strengthening).

Outcomes

Primary Outcome Measures

Pediatric Berg Balance Scale
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).

Secondary Outcome Measures

Selective control assessment of lower extremity (SCALE)
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).

Full Information

First Posted
December 6, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05649501
Brief Title
Effect of PNF on Selective Motor Control and Balance in CP
Official Title
Effects of Proprioceptive Neuromuscular Facilitation on Selective Motor Control of Lower Extremity and Balance in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Cerebral palsy is attributed to non-progressive disturbances that occurred in the developing infant brain or fetal characterized by abnormalities of muscle tone, movement and motor skills. PNF technique is thought to have an impact on voluntary motor control and balance through stimulation of proprioceptors, so the aim of this study is to determine the effects of proprioceptive neuromuscular facilitation technique on selective motor control and balance on children with cerebral palsy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CP (Cerebral Palsy)
Keywords
Proprioceptive neuromuscular techniques, Selective voluntary motor control, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Randomized
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proprioceptive neuromuscular facilitation techniques
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional physical therapy
Arm Type
Active Comparator
Arm Description
this group will receive conventional therapy (ROMs, stretching, strengthening).
Intervention Type
Other
Intervention Name(s)
Proprioceptive neuromuscular facilitation techniques.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Intervention Description
Conventional therapy (ROMs, stretching, strengthening) of lower limbs for 40 minutes.
Primary Outcome Measure Information:
Title
Pediatric Berg Balance Scale
Description
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).
Time Frame
last one week
Secondary Outcome Measure Information:
Title
Selective control assessment of lower extremity (SCALE)
Description
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).
Time Frame
last one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shabana Ashraf, Masters
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Society for Rehabilitation of the Disabled (PSRD)
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1612216
Citation
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.
Results Reference
background
PubMed Identifier
16108461
Citation
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.
Results Reference
background
PubMed Identifier
17370477
Citation
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.
Results Reference
background
PubMed Identifier
16504791
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
21068635
Citation
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.
Results Reference
background
PubMed Identifier
25991061
Citation
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.
Results Reference
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Effect of PNF on Selective Motor Control and Balance in CP

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