Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001362482
Ethics application status
Approved
Date submitted
16/09/2016
Date registered
30/09/2016
Date last updated
26/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance and mobility training at home using Wii Fit in children with cerebral palsy: a feasibility study
Scientific title
Balance and mobility training at home using Wii Fit in children with cerebral palsy: a feasibility study
Secondary ID [1] 289582 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 299331 0
Classified Level I, II or III of the Gross Motor Function Classification System 299332 0
Children with cerebral palsy able to understand simple instructions 299333 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299319 299319 0 0
Physiotherapy
Neurological 299320 299320 0 0
Other neurological disorders
Musculoskeletal 300229 300229 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake mobility training using a Wii Fit U for 25 min per session, three times a week for 8 weeks in their home or school. After screening all games in the Wii Fit U, eight have been selected for mobility training (Ski jump, Table tilt, Perfect 10, Obstacle course, Ultimate obstacle course, Balance bubble, Hula hoop challenge, Step dance). These games consist of a wide range of activities related to mobility, such as squatting, standing, leaning, stepping, or trunk control, as well as being of varying levels of difficulty, and have progression built into the game. Each session will consist of 4 randomly selected games. Random permuted blocks will be used so that after every block (of 4 sessions), all activities will have been practiced the same amount. The score from each game will be used as feedback and motivation. Each participant will be assigned a therapist with at least one year of work-related experience in rehabilitation. This therapist will monitor adherence to the intervention through the Wii software which will record the frequency of use. Before the beginning of training, the therapist will ensure that the participant and parents understand the eight games. They will then supervise one session a week and will also be available to be contacted should the participant or parents require assistance. Participants will continue with usual care (such as physical or occupational therapy) and the amount (total length of time) will be recorded.
Intervention code [1] 295185 0
Rehabilitation
Intervention code [2] 295960 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298802 0
Distance walked during the 6-min Walk Test in m
Timepoint [1] 298802 0
Week 0, 8
Secondary outcome [1] 325246 0
Walking speed during the 10-m Walk Test in m/s
Timepoint [1] 325246 0
Week 0, 8
Secondary outcome [2] 325247 0
Strength of dorsiflexors measured using dynamometry in N
Timepoint [2] 325247 0
Week 0, 8
Secondary outcome [3] 327910 0
Strength of plantarflexors measured using dynamometry in N
Timepoint [3] 327910 0
Week 0, 8
Secondary outcome [4] 327911 0
Strength of quadriceps measured using dynamometry in N
Timepoint [4] 327911 0
Week 0, 8
Secondary outcome [5] 327912 0
Balance measured as the time able to stand on one leg in s
Timepoint [5] 327912 0
Week 0, 8
Secondary outcome [6] 327913 0
Participation measured using the Assistance to Participation Scale scored from 8 to 40 where 40 is maximum participation
Timepoint [6] 327913 0
Week 0, 8

Eligibility
Key inclusion criteria
Children with cerebral palsy will be eligible if they:
1. were diagnosed as cerebral palsy before 5 years of age
2. are between 5 to 13 years old
3. are classified Level I, II or III on the Gross Motor Function Classification System
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with cerebral palsy will be excluded if they:
1. have severe cognitive and/or language deficits which preclude them from participation in the training sessions (as judged by researchers at screening or relatives)
2. have received botulinum toxin or undergone surgery in the lower limbs during the previous 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2016
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
29/04/2017
Date of last data collection
Anticipated
Actual
24/06/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7990 0
Taiwan, Province Of China
State/province [1] 7990 0

Funding & Sponsors
Funding source category [1] 293971 0
Government body
Name [1] 293971 0
Ministry of Science and Technology
Country [1] 293971 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Hsiu-Ching Chiu
Address
No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung City, 82445; Department of Physical Therapy, I-Shou University.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292784 0
University
Name [1] 292784 0
I-Shou University
Address [1] 292784 0
No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung City, 82445
Country [1] 292784 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295386 0
National Cheng Kung University Governance for Human Research Ethics
Ethics committee address [1] 295386 0
National Cheng Kung University Governance for Human Research Ethics
No.1, University Road, Tainan City, 70101
Ethics committee country [1] 295386 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 295386 0
Approval date [1] 295386 0
02/06/2015
Ethics approval number [1] 295386 0
NCKU HREC-F-104-009-2

Summary
Brief summary
Recently, virtual reality in the form of interactive computer games, has been proposed as a potentially promising method of pediatric rehabilitation that meets the requirements of being motivating and engaging, while providing an opportunity for practice and repetition within a virtual environment. Wii Fit U Activities include a dozen fun lower limb activities which provide immediate feedback. Also, they are easy to pick up and play and come with progression built in so that the more difficult levels are able to challenge even the most experienced gamers. These features make it a cost-effective way to provide virtual reality training for mobility. Furthermore, in our previous randomized controlled trial of Wii Sports Resort in the upper limb, we found that the participants completed 554 sessions out of a possible 576, an adherence rate of 96%. Parents were excited that gaming enabled their children to do more things with and like their peers. Therefore, we plan to further examine the effect of Wii activities in the lower limb of children with cerebral palsy. Our aim is, for children with cerebral palsy who are able to understand simple instructions, to improve balance, strength, walking, and participation via Wii Fit U activity training.
Trial website
Trial related presentations / publications
No
Public notes

Contacts
Principal investigator
Name 67074 0
A/Prof Hsiu-Ching Chiu
Address 67074 0
Department of Physical Therapy, I-Shou University (No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung city 82445)
Country 67074 0
Taiwan, Province Of China
Phone 67074 0
+886911863420
Fax 67074 0
Email 67074 0
hsiuchingchiu@isu.edu.tw
Contact person for public queries
Name 67075 0
A/Prof Hsiu-Ching Chiu
Address 67075 0
Department of Physical Therapy, I-Shou University (No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung city 82445)
Country 67075 0
Taiwan, Province Of China
Phone 67075 0
+886911863420
Fax 67075 0
Email 67075 0
hsiuchingchiu@isu.edu.tw
Contact person for scientific queries
Name 67076 0
A/Prof Hsiu-Ching Chiu
Address 67076 0
Department of Physical Therapy, I-Shou University (No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung city 82445)
Country 67076 0
Taiwan, Province Of China
Phone 67076 0
+886911863420
Fax 67076 0
Email 67076 0
hsiuchingchiu@isu.edu.tw

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
SourceTitleYear of PublicationDOI
EmbaseBalance and mobility training at home using Wii Fit in children with cerebral palsy: A feasibility study.2018https://dx.doi.org/10.1136/bmjopen-2017-019624
N.B. These documents automatically identified may not have been verified by the study sponsor.