ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cerebral Palsy

Classified Level I, II or III of the Gross Motor Function Classification System

Children with cerebral palsy able to understand simple instructions

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Other neurological disorders

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Distance walked during the 6-min Walk Test in m

Timepoint [1]

Week 0, 8

Secondary outcome [1]

Walking speed during the 10-m Walk Test in m/s

Timepoint [1]

Week 0, 8

Secondary outcome [2]

Strength of dorsiflexors measured using dynamometry in N

Timepoint [2]

Week 0, 8

Secondary outcome [3]

Strength of plantarflexors measured using dynamometry in N

Timepoint [3]

Week 0, 8

Secondary outcome [4]

Strength of quadriceps measured using dynamometry in N

Timepoint [4]

Week 0, 8

Secondary outcome [5]

Balance measured as the time able to stand on one leg in s

Timepoint [5]

Week 0, 8

Secondary outcome [6]

Participation measured using the Assistance to Participation Scale scored from 8 to 40 where 40 is maximum participation

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Science and Technology

Address [1]

Ministry of Science and Technology
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.

Country [1]

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]

University

Name [1]

I-Shou University

Address [1]

No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung City, 82445

Country [1]

Taiwan, Province Of China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Cheng Kung University Governance for Human Research Ethics

Ethics committee address [1]

National Cheng Kung University Governance for Human Research Ethics
No.1, University Road, Tainan City, 70101

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

Approval date [1]

02/06/2015

Ethics approval number [1]

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

A/Prof Hsiu-Ching Chiu

Address

Department of Physical Therapy, I-Shou University (No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung city 82445)

Country

Taiwan, Province Of China

Phone

+886911863420

Fax

hsiuchingchiu@isu.edu.tw

Contact person for public queries

Name

Hsiu-Ching Chiu

Address

Department of Physical Therapy, I-Shou University (No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung city 82445)

Country

Taiwan, Province Of China

Phone

+886911863420

Fax

hsiuchingchiu@isu.edu.tw

Contact person for scientific queries

Name

Hsiu-Ching Chiu

Address

Department of Physical Therapy, I-Shou University (No.8, Yida Rd., Jiaosu Village, Yanchao District, Kaohsiung city 82445)

Country

Taiwan, Province Of China

Phone

+886911863420

Fax

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

Source	Title	Year of Publication	DOI
Embase	Balance and mobility training at home using Wii Fit in children with cerebral palsy: A feasibility study.	2018	https://dx.doi.org/10.1136/bmjopen-2017-019624

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically