NCT04635930

Brief Summary

The aim of this research is to determine the Effects of taping verse traditional exercises on scapular stabilization and upper limb function in hemiplegic cerebral palsy.Taping and traditional exercises effects on scapular stabilization and support upper limb fuction in Hemiplegic cerebral palsy patients. A randomized controlled trial will be done at hayatabad Medical Complex Peshawar. The sample size is 26. The Participants will be divided into two groups, 13 participants in group A and 13 in Group B. The study duration will 6 months. Sampling technique will purposive non probability sampling technique. Only 6 to 8 years participants with Hemiplegic cerebral palsy will be included. Tools will be used in this study are Quality of upper extremity skill test, The Functional Independence Measure for Children (WeeFIM): Data will be analyzed through Statistical Package of Social Sciences version23.

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 Sep 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

November 15, 2020

Last Update Submit

April 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of upper extremity skills test

    The Quality of upper extremity skills test (QUEST) This measures the upper limb function in four domains, dissociated movements grasp of hand, weight bearing of upper limb and protective extension of upper limb including 33 items. Each item comprises, however, several sub items and both left and right upper extremity is assessed, so a total of 174. This is designed to be used with children who exhibit neuromotor dysfunction with spasticity and has been validated with children 18 months to 8 years.

    8 weeks

Secondary Outcomes (1)

  • The Functional Independence Measure for Children (WeeFIM):

    8 weeks

Study Arms (2)

Taping plus Traditional exercises

EXPERIMENTAL

kinesio tape for improving the alignment of the scapula by inhibiting the hyperactive upper trapezius and facilitating the weak serratus anterior muscleStretching of the tight muscles of upper limb. * Reaching forward sidewise and backward. * Strengthening of the weak muscles by resisted exercise. 2-3 sets of 8-12 repetition, 4 times per week (ACSM guidelines). * Prone lying weight bearing on elbows (four point kneeling) * side sitting with weight bearing on the effected side, for 5 minutes. * Wall pushups. * Catching and throwing of ball

Other: Taping plus Traditional exercises

Traditional exercises

ACTIVE COMPARATOR

Stretching of the tight muscles of upper limb. * Reaching forward sidewise and backward. * Strengthening of the weak muscles by resisted exercise. 2-3 sets of 8-12 repetition, 4 times per week (ACSM guidelines). * Prone lying weight bearing on elbows (four point kneeling) * side sitting with weight bearing on the effected side, for 5 minutes. * Wall pushups. * Catching and throwing of ball

Other: Taping plus Traditional exercises

Interventions

The children will be taped 6 days per week for a total a period of 08 weeks. The tape will be used and keep the scapula in position for 3 days and the region will then be left to rest for 24 hours. Kinesio Taping will then be re-applied by the same experienced research assistants for another 3 days.

Taping plus Traditional exercisesTraditional exercises

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients diagnosed as hemiplegic cerebral palsy.
  • Age group 7 to 14 years.
  • Both males and females.
  • Hemiplegic patients demonstrating weakness of scapular muscles i.e., less than grade 3 on manual muscle testing scale.
  • Hemiplegics who understand and follow verbal commands.

You may not qualify if:

  • Hemiplegic patient with cognitive and perceptual disorders.
  • Hemiplegic patient having sensory, behavioral dysfunction and emotional liability.
  • Hemiplegic patient who is having any associated history of trauma and other medical disorders of hemiplegic upper extremity.
  • Any musculoskeletal structural disorder impeding upper limb function.
  • Participating in any experimental rehabilitation or drug studies.
  • Excessive spasticity that is score of \>3 on modified Ashworth spasticity scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, Pakistan

Location

Related Publications (5)

  • Peters C, Chang A, Morales A, Barnes K, Allegretti A. An integrative review of assessments used in occupational therapy interventions for children with cerebral palsy. Brazilian J Occup Ther. 2019;27(1):168-85.

    BACKGROUND
  • Klingels K, De Cock P, Molenaers G, Desloovere K, Huenaerts C, Jaspers E, Feys H. Upper limb motor and sensory impairments in children with hemiplegic cerebral palsy. Can they be measured reliably? Disabil Rehabil. 2010;32(5):409-16. doi: 10.3109/09638280903171469.

    PMID: 20095955BACKGROUND
  • Kassee C, Hunt C, Holmes MWR, Lloyd M. Home-based Nintendo Wii training to improve upper-limb function in children ages 7 to 12 with spastic hemiplegic cerebral palsy. J Pediatr Rehabil Med. 2017 May 17;10(2):145-154. doi: 10.3233/PRM-170439.

    PMID: 28582885BACKGROUND
  • Camerota F, Galli M, Cimolin V, Celletti C, Ancillao A, Blow D, Albertini G. Neuromuscular taping for the upper limb in Cerebral Palsy: A case study in a patient with hemiplegia. Dev Neurorehabil. 2014 Dec;17(6):384-7. doi: 10.3109/17518423.2013.830152. Epub 2013 Oct 2.

    PMID: 24087981BACKGROUND
  • Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Psychometric and Clinimetric Properties of the Melbourne Assessment 2 in Children With Cerebral Palsy. Arch Phys Med Rehabil. 2017 Sep;98(9):1836-1841. doi: 10.1016/j.apmr.2017.01.024. Epub 2017 Feb 28.

    PMID: 28254639BACKGROUND

Study Officials

  • Saira Waqqar, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 19, 2020

Study Start

September 8, 2020

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations