NCT05649501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

December 6, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

Proprioceptive neuromuscular techniquesSelective voluntary motor controlBalance

Outcome Measures

Primary Outcomes (1)

  • 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).

    last one week

Secondary Outcomes (1)

  • Selective control assessment of lower extremity (SCALE)

    last one week

Study Arms (2)

proprioceptive neuromuscular facilitation techniques

EXPERIMENTAL

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.

Other: Proprioceptive neuromuscular facilitation techniques.

traditional physical therapy

ACTIVE COMPARATOR

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

Other: Proprioceptive neuromuscular facilitation techniques.Other: Traditional physical therapy

Interventions

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.

proprioceptive neuromuscular facilitation techniquestraditional physical therapy

Conventional therapy (ROMs, stretching, strengthening) of lower limbs for 40 minutes.

traditional physical therapy

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Society for Rehabilitation of the Disabled (PSRD)

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 1612216BACKGROUND
  • 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.

    PMID: 16108461BACKGROUND
  • 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.

    PMID: 17370477BACKGROUND
  • 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.

    PMID: 16504791BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 21068635BACKGROUND
  • 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.

    PMID: 25991061BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Shabana Ashraf, Masters

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

February 1, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations