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Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy (KT-SIT_CP)

Primary Purpose

Cerebral Palsy, Kinesiology Taping, Postural Control

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Kinesiology taping
Conventional physiotherapy
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 4 and 14 years
  • diagnosis of motor and cognitive disability
  • have prescribed physiotherapy treatment at school
  • acquisition of autonomous sitting
  • sign the consent informed

Exclusion Criteria:

  • presentation of an allergic reaction to tape
  • presentation of wounds in the area of application of the tape
  • having received botulinum toxin treatment in the last 6 months

Sites / Locations

  • Javier Merino Andrés

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesiology taping

Physiotherapy Group

Arm Description

Apply a kinesiology taping on the abdominal muscles plus conventional physiotherapy

Apply a conventional physiotherapy

Outcomes

Primary Outcome Measures

Posture and Postural Ability Scale - T0
Posture and Postural Ability Scale pre-intervention (PPAS pre). Score from 0 to 7, and the higher the score, the better posture
Posture and Postural Ability Scale - T1
Posture and Postural Ability Scale post-intervention (PPAS post). Score from 0 to 7, and the higher the score, the better posture
Segmental Assessment of Trunk Control - T0
Segmental Assessment of Trunk Control pre-intervention (SATco pre). Score from 1 to 7, and the lower the score, the better balance
Segmental Assessment of Trunk Control - T1
Segmental Assessment of Trunk Control post-intervention (SATco post).Score from 1 to 7, and the lower the score, the better balance

Secondary Outcome Measures

Full Information

First Posted
July 21, 2021
Last Updated
August 4, 2021
Sponsor
University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT04991623
Brief Title
Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy
Acronym
KT-SIT_CP
Official Title
Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Kinesiology Taping, Postural Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesiology taping
Arm Type
Experimental
Arm Description
Apply a kinesiology taping on the abdominal muscles plus conventional physiotherapy
Arm Title
Physiotherapy Group
Arm Type
Active Comparator
Arm Description
Apply a conventional physiotherapy
Intervention Type
Device
Intervention Name(s)
Kinesiology taping
Intervention Description
We used kinesiology taping in abdominal muscles
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
We used conventional physiotherapy to comparate
Primary Outcome Measure Information:
Title
Posture and Postural Ability Scale - T0
Description
Posture and Postural Ability Scale pre-intervention (PPAS pre). Score from 0 to 7, and the higher the score, the better posture
Time Frame
pre-intervention
Title
Posture and Postural Ability Scale - T1
Description
Posture and Postural Ability Scale post-intervention (PPAS post). Score from 0 to 7, and the higher the score, the better posture
Time Frame
at 10 days
Title
Segmental Assessment of Trunk Control - T0
Description
Segmental Assessment of Trunk Control pre-intervention (SATco pre). Score from 1 to 7, and the lower the score, the better balance
Time Frame
pre-intervention
Title
Segmental Assessment of Trunk Control - T1
Description
Segmental Assessment of Trunk Control post-intervention (SATco post).Score from 1 to 7, and the lower the score, the better balance
Time Frame
at 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 4 and 14 years diagnosis of motor and cognitive disability have prescribed physiotherapy treatment at school acquisition of autonomous sitting sign the consent informed Exclusion Criteria: presentation of an allergic reaction to tape presentation of wounds in the area of application of the tape having received botulinum toxin treatment in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Merino Andrés, MSc
Phone
925268800
Ext
5822
Email
Javier.Merino@uclm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Merino Andrés, MSc
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Javier Merino Andrés
City
Toledo
ZIP/Postal Code
45006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy

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