Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001264471
Ethics application status
Approved
Date submitted
25/08/2016
Date registered
8/09/2016
Date last updated
22/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Kinesio Taping (KT) on Postural Balance and Gait in School Children with Moderate Intellectual Disability (ID)
Scientific title
The Effect of Kinesio Taping (KT) on Postural Balance and Gait in School Children with Moderate Intellectual Disability (ID)
Secondary ID [1] 290013 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intellectual disability 300030 0
balance 300031 0
gait 300032 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299926 299926 0 0
Physiotherapy
Mental Health 299927 299927 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In obligatory Physical Education (PE) classes, the experimental group will perform dual-task exercises consisting in improving motor functions (activities of daily living) and stimulating righting reactions, working with the same physiotherapists. The programme will comprise dual-task exercises in which on unstable surfaces (stability balls, sensory air cushions ans soft mattresses) participants will perform functional tasks consisting of ADLs (for example: putting on and taking off footwear). The intervention programme will last for 12 weeks, and will include 45-minute training sessions conducted three times per week. Additionally, it will be supplemented by the Kinesio Taping (KT) method during its whole length of 12 weeks. Elastic tapes will be applied according to well established methods by a trained physiotherapist on the sole side of both feet and they should be kept in situ for six days. After this period, a day of rest will be left in between to prevent skin intolerance and KT will be applied again.
Before commencing the intervention and after 12 weeks, postural balance and foot typology will be assessed in all participants of the project on the BTS P-WALK platform and the quality of gait by means of a G-SENSOR. All measurements will be performed by the same independent researcher.
Intervention code [1] 295729 0
Rehabilitation
Comparator / control treatment
The controls will participate in obligatory PE classes in the same programme as the experimental group, combining dual-task exercises focused on improving motor functions (activities of daily living) and stimulating righting reactions. The intervention will be conducted individually for 12 weeks and will include 45-minute training sessions conducted three times per week.
Control group
Active

Outcomes
Primary outcome [1] 299411 0
The influence of kinesio taping on balance – assessed by baropodometric platform.
Timepoint [1] 299411 0
Baseline and immediately after 12 weeks.
Primary outcome [2] 299412 0
The influence of kinesio taping on foot typology – assessed by baropodometric platform.
Timepoint [2] 299412 0
Baseline and immediately after 12 weeks.
Primary outcome [3] 299413 0
The influence of kinesio taping on load distribution – assessed by baropodometric platform.
Timepoint [3] 299413 0
Baseline and immediately after 12 weeks.
Secondary outcome [1] 327095 0
The influence of kinesio taping on gait – assessed by BTS G-WALK.
Timepoint [1] 327095 0
Baseline and immediately after 12 weeks.

Eligibility
Key inclusion criteria
mild and moderate intellectual disability, Down Syndrome, ability to follow verbal instructions, ambulated without orthopaedic devices
Minimum age
10 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
major physical disabilities, hyperactivity, inability to follow instructions, skin diseases, intolerance skin on the tape application

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
50
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 8123 0
Poland
State/province [1] 8123 0

Funding & Sponsors
Funding source category [1] 294383 0
University
Name [1] 294383 0
University of Physical Education in Krakow
Country [1] 294383 0
Poland
Primary sponsor type
Individual
Name
Edyta Mikolajczyk
Address
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 293232 0
None
Name [1] 293232 0
Address [1] 293232 0
Country [1] 293232 0
Other collaborator category [1] 279176 0
Individual
Name [1] 279176 0
Agnieszka Jankowicz-Szymanska
Address [1] 279176 0
State Higher Vocational School
ul. A. Mickiewicza 8, 33-100 Tarnow
Country [1] 279176 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295806 0
Ethical Committee of Regional Medical Association in Krakow
Ethics committee address [1] 295806 0
Ethics committee country [1] 295806 0
Poland
Date submitted for ethics approval [1] 295806 0
Approval date [1] 295806 0
12/02/2012
Ethics approval number [1] 295806 0
19/KBL/OIL/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1066 1066 0 0
/AnzctrAttachments/371371-Nr 19-KBL-OIL-2012.pdf (Ethics approval)

Contacts
Principal investigator
Name 68542 0
Dr Edyta Mikolajczyk
Address 68542 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 68542 0
Poland
Phone 68542 0
+48 12 6831167
Fax 68542 0
Email 68542 0
[email protected]
Contact person for public queries
Name 68543 0
Edyta Mikolajczyk
Address 68543 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 68543 0
Poland
Phone 68543 0
+48126831167
Fax 68543 0
Email 68543 0
[email protected]
Contact person for scientific queries
Name 68544 0
Edyta Mikolajczyk
Address 68544 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 68544 0
Poland
Phone 68544 0
+48126831167
Fax 68544 0
Email 68544 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.