NCT05304676

Brief Summary

Children with cerebral palsy (CP) manifest several developmental disorders of movement and posture. CP children have functional limitations so this study investigates the additional effects of kinesio taping and neuromuscular electrical stimulation on hands joint range of motion, muscle tone and functional ability in children with hemiplegic cerebral palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

January 21, 2022

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Jebsen Hand Function Test

    The Jebsen Hand Function Test (JHFT/JTT) was developed to provide a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living. It consists of seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects.Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance.Change from Baseline hand functions to 4th Week

    4 weeks

  • Minnesota Hand Skill Test

    The Minnesota Manual Dexterity test (MMDT) tool was developed to measure unilateral and bilateral gross and fine manual dexterity.his involved a series of displacement and turning of plastic or wooden cylinders to be placed in a series of matched holes. A log is maintained of the time taken for these steps.Change from Baseline manual ability and hand dexterity to 4 Week

    4 Week

  • Goniometer

    Goniometer is used to measure range of motion of joints, following joints will be assessed shoulder, elbow, wrist. Change from Baseline manual ability and hand dexterity to 4 Week

    4Week

Secondary Outcomes (2)

  • Manual Ability Classification System

    4Weeks

  • Gross Motor Function Classification System

    4Weeks

Study Arms (2)

KTT group

EXPERIMENTAL

This group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation. Children will be treated for 3 days a week over 4 weeks.

Other: Experimental: KTT group

Conventional treatment

ACTIVE COMPARATOR

Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.

Other: Active Comparator: conventional treatment

Interventions

This group will receive neurodevelopmental treatment along with kinesotape and neuromuscular electrical stimulation

KTT group

Group B will receive neurodevelopment treatment along with neuromuscular electrical stimulation.

Conventional treatment

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 3 year to 15 year
  • Gender: Both Male and female.
  • Diagnosis with hemiplegic cerebral palsy
  • Refer for physiotherapy
  • Classified as Gross Motor Function Classification System level II, III
  • Ashworth grading: 1-3
  • Able to follow and accept verbal instruction and communication

You may not qualify if:

  • Medical procedures likely to affect motor function such as botulinum toxin injection.
  • Any kind of surgery.
  • Mental retardation or learning disability.
  • Any other abnormality and pathology condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute of Rehabilitation and Medicine

Islamabad, 46000, Pakistan

Location

Misbah Ghous

Rawalpindi, 46000, Pakistan

Location

Related Publications (4)

  • Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006 Jul;48(7):559-63. doi: 10.1017/S0012162206001186.

    PMID: 16780624BACKGROUND
  • Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.

    PMID: 16272660BACKGROUND
  • Acıkbas E, Tarakcı D, Budak M. Comparison of the effects of Kinesio taping and neuromuscular electrical stimulation on hand extensors in children with cerebral palsy. Int J Ther Rehabil. 2020. https://doi.org/10.12968/ ijtr.2019.0053

    BACKGROUND
  • Kitai Y, Haginoya K, Hirai S, Ohmura K, Ogura K, Inui T, Endo W, Okubo Y, Anzai M, Takezawa Y, Arai H. Outcome of hemiplegic cerebral palsy born at term depends on its etiology. Brain Dev. 2016 Mar;38(3):267-73. doi: 10.1016/j.braindev.2015.09.007. Epub 2015 Oct 1.

    PMID: 26428444BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah college of Rehabilitation and Allied Health sciences Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 21, 2022

First Posted

March 31, 2022

Study Start

March 15, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations