ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001149550

Ethics application status

Approved

Date submitted

20/10/2015

Date registered

28/10/2015

Date last updated

27/05/2020

Date data sharing statement initially provided

27/05/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

iStride: A locomotor training program for children with cerebral palsy

Scientific title

The effects of a 6 week functional electrical stimulation (FES) assisted locomotor training program compared to locomotor training alone on functional mobility in children with bilateral spastic cerebral palsy: a randomised controlled trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1175-7012

Trial acronym

Linked study record

Health condition

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

Bilateral spastic cerebral palsy

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention group will receive a 6 week FES robotic assisted locomotor training program 3 times a week for 6 weeks. Each session will be 1.5 hours in duration and will be comprised of 3 main parts. The first part will include bilateral neuromuscular electrical stimulation (NMES) to the hamstrings and quadriceps while using the RT600 - an FES robotic locomotor device that synchronises NMES during a gait cycle (30 minutes). The second part will be a treadmill body weight supported locomotor program both with and without physical facilitation (20 minutes). The treadmill program will be based on principles of fitness training using intervals that are determined by individual heart rate responses (aiming for 50-70% HRMax i.e. moderate to vigorous physical activity). Finally, children will practice overground walking in their walking frames with focus on improving functional use through lower limb patterning and steering ability (15 minutes). The remaining 25 minutes will include preparation into the harness, placement of electrodes and transfers between equipment. Attendance will be registered as well as clinical progress notes (as per standard clinical practice) to document subjective reports, objective observations, individual responses and evaluation of treatment session.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The control group will undergo a locomotor training program using the treadmill and overground walking component only. The treadmill body weight supported locomotor program will be both with and without physical facilitation (50 minutes). The treadmill program will be based on principles of fitness training using intervals that are determined by individual heart rate responses (aiming for 50-70% HRmax i.e. moderate to vigorous physical activity). Children will then practice overground walking in their walking frames with focus on improving functional use through lower limb patterning and steering ability (15 minutes). The remaining 25 minutes will include preparation into the harness and transfers between equipment. Attendance will be registered as well as clinical progress notes (as per standard clinical practice) to document subjective reports, objective observations, individual responses and evaluation of treatment session.

Control group

Active

Outcomes

Primary outcome [1]

10 meter walk test performed in the child's usual mobility device

Timepoint [1]

Post treatment i.e. week 6

Primary outcome [2]

Goal Attainment Scale based on ambulation e.g. change in walking ability, change in support or supervision required.

Timepoint [2]

Post Treatment i.e. week 6

Secondary outcome [1]

10 meter walk test performed in the child's usual mobility device

Timepoint [1]

Follow up ( 6 months)

Secondary outcome [2]

Goal Attainment Scale e.g. change in walking ability, change in support or supervision required.

Timepoint [2]

Follow up (6 months)

Secondary outcome [3]

Mobility score on the WeeFIM

Timepoint [3]

Post treatment i.e week 6

Secondary outcome [4]

Mobility score on the WeeFIM

Timepoint [4]

Follow up (6 months)

Secondary outcome [5]

Performance and Satisfaction scores on the Canadian Occupational Performance Measure

Timepoint [5]

Post treatment i.e. week 6

Secondary outcome [6]

Performance and Satisfaction on the Canadian Occupational Performance Measure

Timepoint [6]

Follow up (6 months)

Secondary outcome [7]

Gross Motor Function Measure

Timepoint [7]

Post treatment i.e. week 6

Secondary outcome [8]

Gross Motor Function Measure

Timepoint [8]

Follow up (6 months)

Eligibility

Key inclusion criteria

Children with bilateral spastic cerebral palsy (may include mixed signs with dyskinesia and hypertonia)
Aged between 5 and 12 years
Able to follow simple instructions (to perform the 10 meter walk test)
Gross motor function classification system Level III, IV or V i.e. those who typically require mobility devices to walk
Accepted to receive iRehab services through Princess Margaret Hospital (tertiary level referral)
Parent identified performance problems that include difficulty with transfers or difficulty with use of walking frame and mobility
Current use of an assistive walking device (must already have one and is currently being used)
Children must have a community therapy provider
Children must be at least 3 months post botulinum toxin injections

Minimum age

5 Years

Maximum age

12 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Engagement in activity based rehabilitation locomotor training in the past 6 months
Uncontrolled seizure disorder
Orthopaedic Surgery in the past 12 months

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Once participants have been confirmed to be eligible for the study, a person uninvolved in the study will provide the allocation using sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A dynamic random allocation method (i.e. minimisation) will be used. Children will be allocated to the groups using a simple coin toss by a person uninvolved in the study once 2 children have been enrolled that are (a) within 2 years of age and (b) the same GMFCS level.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The program will run for a period of 15 months. During this time, we anticipate that we will be able to recruit 20 children per group. This is based on current referral statistics to the iRehab service at Princess Margaret Hospital for Children with mobility related goals in children with bilateral spastic cerebral palsy between the ages of 5 and 12. This will be sufficient to detect a large effect in favour of the intervention group at a power of 0.80 and an alpha of 0.05 (two tailed test) for the primary outcome of mobility (effect size d=0.8).
Normality will be established for all measures through examining distributional plots, Q-plots and the Shapiro-Wilk test. For data that is normally distributed, parametric tests will be applied with means and standard deviations for each group at each assessment time point reported. For ordinal data, or where data is not normally distributed despite transformations, non-parametric tests will be applied with medians and interquartile ranges reported. Intention to treat analysis will be applied.

Mixed Models will be applied to account for repeated measures between groups over time (post treatment and follow-up) and enable within group comparisons over time (post treatment compared to baseline and follow-up compared to baseline). The advantage of the Mixed Models is that it will account for any missing data.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/10/2016

Actual

1/11/2016

Date of last participant enrolment

Anticipated

28/02/2018

Actual

30/03/2018

Date of last data collection

Anticipated

28/09/2018

Actual

28/06/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Telethon - Perth Children's Hospital Research Fund

Address [1]

Roberts Road, Subiaco, Western Australia 6008

Country [1]

Australia

Primary sponsor type

Individual

Name

Dayna Pool

Address

Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Jane Valentine

Address [1]

Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Catherine Elliott

Address [2]

Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital Ethics Committee

Ethics committee address [1]

Roberts Road Subiaco, Western Australia, 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/12/2015

Approval date [1]

18/02/2016

Ethics approval number [1]

Summary

Brief summary

Cerebral palsy is the most common cause of physical disability in childhood. Physiotherapy is an important patient focused healthcare delivery intervention that is necessary to improve functioning of muscles, walking and in the prevention of deformities. The life-long impact of cerebral palsy is higher than many conditions because of the early age onset. Hence physiotherapy needs to be provided from an early age to influence not only muscular structure (such as strength and flexibility) but also neurological structures such as the brain - which can learn and change when given the right stimulus to do so. There has been a recent paradigm shift in how to train and promote walking in people with neurological conditions. Activity and intensity of training are crucial and much of this has been drawn from neurological research and spinal cord injury research. It is increasingly recognized that teaching the pattern of walking is important to stimulate the central pattern generators – the intrinsic and reflexive pathways in our neurological system that guide movement.  

This approach is not well understood in the area of cerebral palsy but given the theoretical foundation combined with our clinical experience and observations that have demonstrated feasibility and potential efficacy, a controlled larger scale study is necessary. This is particularly relevant because technology is now increasingly available in the community but is supported by limited evidence. Evidence based approaches are necessary to ensure ethical use of limited funds.

The significance of this research recognizes that one in three children with cerebral palsy cannot walk and rely on equipment aides and physical support from carers. Hence programs focusing on walking will address known issues due to sedentary behaviour in children with cerebral palsy and in the prevention of obesity and pain. Such interventions will improve independence and functioning hence reducing the burden of care, which is by far, accountable for the highest economic impact of this condition. Therefore training to walk at an early age even with the use of mobility aides such as walking frames actually translates to increasing and maintaining movement, strength, independence, function, participation and well-being to reduce the burden of care not just for short term gain but well into the future as children become adults.


This approach combines the knowledge and principles needed to improve muscular structures, central pattern generators and an avenue to improve walking speed and endurance in young children with cerebral palsy even though children are classified as having lower gross motor function (GMFCS III, IV and V). 

The primary aim of this research is to determine if robotic assistive rehabilitation improves functional mobility in children with cerebral palsy who usually require assistance to walk and reduced burden of care for their parents and families.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dayna Pool

Address

Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008

Country

Australia

Phone

+61 8 9340 8886

Fax

Dayna.Pool@health.wa.gov.au

Contact person for public queries

Name

Dayna Pool

Address

Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008

Country

Australia

Phone

+61 8 9340 8886

Fax

Dayna.Pool@health.wa.gov.au

Contact person for scientific queries

Name

Dayna Pool

Address

Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008

Country

Australia

Phone

+61 8 9340 8886

Fax

Dayna.Pool@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

This was not included in the ethics submission.

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	Locomotor and robotic assistive gait training for children with cerebral palsy.	2021	https://dx.doi.org/10.1111/dmcn.14746

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

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Documents added automatically