NCT02073513

Brief Summary

BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands. OBJECTİVES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure hand function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

December 12, 2013

Last Update Submit

February 25, 2014

Conditions

Keywords

Spasticity, Hand Function, Cerebral Palsy, Kinesiotape

Outcome Measures

Primary Outcomes (1)

  • Nine hole peg test

    at baseline (before application), at 20 minutes after application, at 20 minutes after application removed

Secondary Outcomes (1)

  • nine parts puzzle test

    at baseline (before application), at 20 minutes after application, at 20 minutes after application removed

Study Arms (3)

kinesiotape plus thenar pressure (PPTG)

EXPERIMENTAL

In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied which controled the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied. The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions.

Device: Kinesiotape plus thenar pressure (PPTG)

Taping Group (TG)

EXPERIMENTAL

In the taping group (TG) kinesiotape was applied to control the cortical thumb sign.

Device: Taping Group (TG)

Control Group (CG)

NO INTERVENTION

No application.

Interventions

In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied to control the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied. The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions.

kinesiotape plus thenar pressure (PPTG)

In the taping group (TG) kinesiotape was applied to control the cortical thumb sign.

Taping Group (TG)

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of Cerebral Palsy
  • Stable clinical status
  • Hand and/ or wrist spasticity
  • No passive movement limitation
  • Receiving regular neurodevelopmental rehabilitation
  • Sufficient cognitive level

You may not qualify if:

  • Surgery of the upper extremity
  • Orthotic treatment
  • Sensory deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle SpasticityCerebral Palsy

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Fatma UYGUR, Prof. PhD.

    Hacettepe University Ethical Committee

    STUDY DIRECTOR

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
Research Assistant, MsC, PT

Study Record Dates

First Submitted

December 12, 2013

First Posted

February 27, 2014

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations