NCT03819205

Brief Summary

Cerebral palsy (CP) is defined as a non-progressive lesion of the immature brain. Children with CP may present with a variety of motor impairments. The impaired upper limb function of children with cerebral palsy (CP) limits and restricts participation in activities of daily living. Kinesio Taping (KT) is commonly used in sport injuries, in neurology and oncology patients following the surgical protocols, and for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception. Kinesiotaping is a treatment that has not been studied much and can be applied in cerebral palsy. The tapes were grouped as elastic and rigid. In fact, there has been a few studies that investigates the effect of upper extremity elastic kinesiotaping. High methodological studies about its efficacy in this population are rare.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

April 15, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 23, 2019

Last Update Submit

January 25, 2019

Conditions

Keywords

cerebral palsyupper extremity kinesiotapingmodified house

Outcome Measures

Primary Outcomes (2)

  • Box and block test

    With the stopwatch, it is recorded how many small cubes are transferred to the other side of the box within 60 seconds.

    1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)

  • Nine hole peg test

    A wooden box with nine holes is placed in front of the patient and held in seconds with the stopwatch. Insersion and extraction time of pegs in second are noted.

    1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)

Secondary Outcomes (2)

  • Modified house clasification score

    1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)

  • Active/passive wrist dorsiflexion range of motion

    1 week before kinesiotaping and 1 week after the period of kinesiotaping (change form baseline will be evaluated)

Study Arms (1)

kinesiotaping group(before/after)

EXPERIMENTAL

* Hemiplegic CP:Kinesiotaping on the affected side * Diplegic, tetraplegic CP: side of upper extremity which children have been used to but have obstacles in daily life * intervention Duration: For 1 week at least 2-3 hours a day, renewing if it's necessary. * Note:Patients will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. * Evaluation: In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion

Other: kinesiotaping

Interventions

The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion

kinesiotaping group(before/after)

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 6-18
  • Following up with diagnose of hemiplegic/diplegic/tetraplegic CP patients with current imaginig findings
  • Patient with stable clinical status
  • Stage ≤2 patients depended on the modified ascwort scale
  • Patients who are eligible to participate the study tests with suitable cognitive state
  • Patients who agreed to participate the study.

You may not qualify if:

  • Stage \>2 patients depended on the modified ascwort scale
  • Botilinum toxin intervention to the upper extremity in the last 6 months.
  • Patients who undergo upper extremity surgery.
  • Patients who have contraindication for kinesiotaping (Wide and severe skin injury, open wounds at risk of infection , allergic reactions)
  • Patients with intense sensory and motor loss in the banding area
  • Patients classified in stage IIB and above according to Zancolli stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, İ̇zmi̇r, 35340, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Zeynep Tokel, MD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: self-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: Principal investigator

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 28, 2019

Study Start

April 15, 2018

Primary Completion

March 10, 2019

Study Completion

March 10, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations