Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001235493
Ethics application status
Approved
Date submitted
3/08/2016
Date registered
5/09/2016
Date last updated
10/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Dual-task Functional Exercises on Balance and Gait in People with Moderate Intellectual Disability
Scientific title
The Effect of Dual-task Functional Exercises on Balance and Gait in People with Moderate Intellectual Disability
Secondary ID [1] 289832 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
balance 299760 0
gait 299761 0
intellectual disability 299762 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299696 299696 0 0
Other physical medicine / rehabilitation
Mental Health 299697 299697 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents from the experimental group will take part in obligatory PE classes whose plans will be identical for all of them and will consist of general fitness exercises and music therapy. They will additionally take part in a 24-week dual-task intervention programme and will attend 45-minute training session three times per week, working individually with the same physiotherapists. The programme will comprise dual-task exercises in which on unstable surfaces (stability balls, sensory air cushions and soft mattresses) participants will perform functional tasks consisting of ADLs. All exercises will be accompanied by the physiotherapist’s verbal instructions about focusing on the task accomplishment, the direction and target of the movement and proper postural control.
The effectiveness of the applied exercise programme will be assessed by examining the quality of balance and gait.
Before commencing the intervention (test 1), after 12 weeks (test 2), after another 12 weeks (test 3) and after the 8-week summer holidays (test 4) postural balance will be assessed in all participants of the project on the stabilometric platform Alfa and the quality of gait by means of a BTS G-WALK. All measurements will be performed by the same independent resercher.
Intervention code [1] 295512 0
Rehabilitation
Comparator / control treatment
The controls will take part in obligatory PE classes whose plans will be identical for all of them and will consist of general fitness exercises and music therapy (the same as in the experimental group).
Control group
Active

Outcomes
Primary outcome [1] 299406 0
Influence of dual-task functional exercises on unstable surfaces on static balance.

Static balance will be assessed by stabilometric platform Alfa (manufactured by AC International East, and distributed by Technomex Ltd.).
Timepoint [1] 299406 0
At baseline (test 1), immediately after 12 weeks (test 2), immediately after 24 weeks (test 3) and after the 8-week summer holidays (test 4).
Primary outcome [2] 299407 0
Influence of dual-task functional exercises on unstable surfaces on dynamic balance.

Dynamic balance will be assessed by stabilometric platform Alfa (manufactured by AC International East, and distributed by Technomex Ltd.).
Timepoint [2] 299407 0
At baseline (test 1), immediately after 12 weeks (test 2), immediately after 24 weeks (test 3) and after the 8-week summer holidays (test 4).
Secondary outcome [1] 327087 0
Influence of dual-task functional exercises on unstable surfaces on gait.

Gait analysis will be assessed by means BTS G-WALK (manufactured by BTS Bioengineering, and distributed by Technomex Ltd.).
Timepoint [1] 327087 0
At baseline (test 1), immediately after 12 weeks (test 2), immediately after 24 weeks (test 3) and after the 8-week summer holidays (test 4).

Eligibility
Key inclusion criteria
moderate intellectual disability, ability to follow verbal instructions, ambulated without orthopaedic devices
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
major physical disabilities, hyperactivity, inability to follow instructions

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
Completed
Date of first participant enrolment
Anticipated
Actual
17/12/2012
Date of last participant enrolment
Anticipated
Actual
30/12/2012
Date of last data collection
Anticipated
Actual
8/09/2013
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8071 0
Poland
State/province [1] 8071 0

Funding & Sponsors
Funding source category [1] 294381 0
Self funded/Unfunded
Name [1] 294381 0
Country [1] 294381 0
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] 293230 0
None
Name [1] 293230 0
Address [1] 293230 0
Country [1] 293230 0
Other collaborator category [1] 279175 0
Individual
Name [1] 279175 0
Agnieszka Jankowicz-Szymanska
Address [1] 279175 0
State Higher Vocational School
ul. A. Mickiewicza 8, 33-100 Tarnow
Country [1] 279175 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295621 0
Ethical Committee of Regional Medical Association in Krakow
Ethics committee address [1] 295621 0
Ethics committee country [1] 295621 0
Poland
Date submitted for ethics approval [1] 295621 0
Approval date [1] 295621 0
12/12/2012
Ethics approval number [1] 295621 0
18/KBL/OIL/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67698 0
Dr Edyta Mikolajczyk
Address 67698 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 67698 0
Poland
Phone 67698 0
+48 12 6831167
Fax 67698 0
Email 67698 0
[email protected]
Contact person for public queries
Name 67699 0
Edyta Mikolajczyk
Address 67699 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 67699 0
Poland
Phone 67699 0
+48 12 6831167
Fax 67699 0
Email 67699 0
[email protected]
Contact person for scientific queries
Name 67700 0
Edyta Mikolajczyk
Address 67700 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Krakow
Country 67700 0
Poland
Phone 67700 0
+48126831167
Fax 67700 0
Email 67700 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.