NCT06326164

Brief Summary

The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 15, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

February 29, 2024

Last Update Submit

March 16, 2024

Conditions

Keywords

cerebral palsy- Diplegia- Kinesio-taping- Balance- Gait

Outcome Measures

Primary Outcomes (2)

  • Change in gait.

    Measurement of gait using Kinovea software.

    Change from Baseline gait at twelve weeks.

  • Change in balance.

    Measurement of balance using the Biodex balance system.

    Change from Baseline balance at twelve weeks.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Control group.

Procedure: kinesio-taping.

Group B

ACTIVE COMPARATOR

Experimental group.

Procedure: kinesio-taping.Procedure: A designed physiotherapy program.

Interventions

A therapeutic tape that's applied strategically to the body to provide support, reduce pain, swelling and improve performance. Kinesio taping will be applied on both lower limbs. Taping will be applied for 4 days, 24 hours a day, on the lower limbs, and it will be removed for only one day per week.

Group AGroup B

The designed physiotherapy program included passive stretching, weight bearing, muscle strengthening, functional exercises, neurodevelopmental treatment, splinting, balance training, and gait training. The treatment protocol will be repeated each session per weeks for twelve weeks.

Group B

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • A medical diagnosis of spastic diplegic cerebral palsy made by pediatricians or pediatric neurologists.
  • Children with spasticity grades ranged from 1 to 1 plus according to Modified ashworth scale.
  • Their age range from 6 to 10 years.
  • Children who can stand with poor balance and recognize and follow verbal orders and commands included in both testing and training techniques
  • No orthopedic surgeries

You may not qualify if:

  • Children who have skin sensitivity for using kinesio-taping.
  • A history of cardiac or orthopedic disability.
  • Children having visual or auditory defects.
  • They had a permanent deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Mohamed Khalil Sedeek

Kafr ash Shaykh, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • A M KH, Bachelor's

    Faculty of Physical Therapy Kafrelsheikh University

    PRINCIPAL INVESTIGATOR
  • M B I, Ass. Prof

    Faculty of physical therapy Kafrelsheikh university

    STUDY CHAIR
  • O A AE, Professor

    Faculty of medicine Kafrelshiekh university

    STUDY CHAIR
  • S Y AE, lecturer

    Faculty of physical therapy Kafrelshiekh university

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 22, 2024

Study Start

February 15, 2024

Primary Completion

June 15, 2024

Study Completion

July 18, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations