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Trial registered on ANZCTR


Registration number
ACTRN12619000064101
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
17/01/2019
Date last updated
26/03/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kindy Moves: An intensive interdisciplinary activity based program for children with neurological conditions and injuries.
Scientific title
Kindy Moves: An intensive interdisciplinary activity based therapy program to address functional mobility goals in children with neurological conditions and injuries.
Secondary ID [1] 297006 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 310975 0
Acquired brain injuries 310976 0
Spinal cord injuries
310977 0
Lissencephaly
310978 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309638 309638 0 0
Physiotherapy
Physical Medicine / Rehabilitation 309639 309639 0 0
Occupational therapy
Physical Medicine / Rehabilitation 309640 309640 0 0
Speech therapy
Neurological 309746 309746 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 309747 309747 0 0
Other human genetics and inherited disorders
Injuries and Accidents 309748 309748 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Kindy Moves Intervention
Each participant will have a therapist or therapy assistant working directly with them. Participants will attend 3 sessions a week (each session being 2 hours in duration) for 4 weeks.

The 2 hour program will be divided into 3 main sections (of which all children will experience in a session) and will be the basis for each of the sessions.

1. Floor Time (30 minutes)

This morning routine is commonly done at school where children will introduce themselves, engage in interactive songs, engage in book time and be required to turn take. Each child will be able to actively participate in this morning session with the use of adaptive seating, adapted toys and books, inclusion of switches with pre-recorded voices for children who are not able to vocalise independently. The main goal in this session is to improve the confidence for children to be able to actively engage in morning routines through socialisation and play. Importantly, gross motor goals (individually specific) will be incorporated into this session i.e. children may need to practice sitting, crawling, kneeling or standing. A therapist will work with each child individually to ensure that the program remains individually specific, targeting family directed goals (obtained from the Canadian Occupational Performance Measure) within an interactive group setting.

2. Locomotor training and overground walking (50 minutes).

Locomotor training will occur with and without facilitation on a treadmill with partial body weight support using principles of interval training with incremental increases in speed based on individual heart responses: 30 minutes. This will be followed by overground training with practice in their own walking frame – 20 minutes (to mimic morning recess time where children can be in their walking frames with other children). This will be carried out by 2 therapists.

The treadmill training protocol is based on the Behrman and Harkema (2000)25 protocol and Day et al (2004). The main principles are (a) to walk at speeds that match overground walking (0.8 – 1.5km/hr), (b) enable maximum sustainable load on the stance/weight bearing limb, (c) maintaining an upright and extended trunk and head, (d) approximating normal hip, knee and ankle kinematics during gait, (e) synchronising timing of extension of the hip in stance and unloading of limb with simultaneous loading of the contralateral limb, (f) avoiding weight bearing through the arms, (g) minimise sensory stimulation that conflicts with sensory information associated with locomotion.

Orthoses (ankle foot orthoses) will be used for all locomotor training – this will ensure maintenance of integrity of foot position and a stable weight bearing surface. Ankle foot orthoses are routinely prescribed for children with cerebral palsy and is considered standard practice.

Locomotion training includes two parts: step training on a treadmill and walking overground (using their own walking frames)

Step Training on the Treadmill
A harness will be worn by the participant. The harness is connected to an overhead motorised frame/lift that is placed over the treadmill. The level of weight support will be adjusted to maximise bilateral limb weight bearing and ease of foot clearance during the swing phase of gait. As a standard, this will commence with the body weight support at 60%.
Hand positioning will be standardised with one person on each side of the leg to facilitate stepping. Particular attention will be given to foot clearance and simultaneous heel strike of one limb and toe off on the other limb for swing. Props like bean bags (to encourage the child to step over) will be used to promote hip and knee flexion. Songs will be sung to assist with timing and motivation.

Duration of the session is determined by (a) participant fatigue, (b) maintenance of step patterns and weight shift.

Progression of step training
1. Reaching an optimal speed (specific for each participant based on their baseline speeds determined on the 10MWT);
2. Minimizing the amount of manual assistance required;
3. Decreasing the body weight support (aiming to get to 20% body weight support);
4. Increasing the duration to 3, 10 minute sessions.

Overground training
This will be performed after each treadmill session. The child will be placed in their usual mobility device. Verbal prompts will be given for consistent stepping. Children will walk around the gym area with progression of training:
1. Walking in straight lines on a level surface
2. Walking around obstacles on a level surface
3. Walk and stop and restart walking again without support i.e. be able to independently generate appropriate stepping mechanics.

3. Individualised session on upper limb functional readiness (30 minutes).

During this session, children will work directly with a therapist on an upper limb related goal. This may include the promotion of bilateral or bimanual hand use. To facilitate this, functional electrical stimulation (which involves the use of electrical impulses that are delivered through adhesive pads placed on the skin over the target muscle) may be used. The use of functional electrical stimulation will assist muscles to activate or contract so that they can be used for an activity such as picking up a ball or toy or to activate a switch for function. This activity promotes independence for children with a physical disability by providing a means of control to facilitate participation. Functional Electrical Stimulation is a safe and approved treatment modality that is used both in the community and tertiary centres. Introduction to the electrical impulse sensation is likely to take 1 week. The frequency introduced will be 50Hz with a low pulse width of 50 microseconds. Amplitude will be increased as needed in order to obtain a muscle contraction. This is individual for each child. These settings will enable the introduction of the stimulation whilst also considering the neuromuscular requirements for obtaining a muscle contraction. The duration of the stimulation will be actively triggered by the therapist so that when the child is attempting to complete a functional activity, the stimulation is turned on. The stimulation is turned off (using a trigger button) as the child finishes the activity. For example, as the child reaches to open their hand to hold a ball, the stimulation is triggered on the wrist extensors. Once the child is able to put their hand over the ball, the stimulation is turned off which will enable grasp. These settings have also been routinely used within the iRehab service (at The Perth Children’s Hospital) and The Healthy Strides Foundation with good tolerance.

Procedures for monitoring adherence and fidelity to intervention.
The nature of this program is that it is intense in that there are 6 therapy hours provided each week. We will therefore monitor and document the attendance rate throughout the 4 week program. The exit interview will also discuss the program in more detail which will help better appreciate the acceptability and practicality for families to be involved in such a program. Participants will be asked not to participate in any other intensive forms of therapy during the program until the one month follow up. Progress notes will be made after each session to enable commence on adherence. Each program will follow the outline noted above but there will be individualised aspects. This program will be created by the principal investigator which will guide the entire program. The principal investigator will be supervising each of the sessions to optimise fidelity to intervention.
Intervention code [1] 313282 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318599 0
Goal Attainment Scale (GAS)
The Goal Attainment Scale (GAS) is used to enable individualised goal setting. The purpose of using the GAS is to assess the achievement of individually important and specific goals that involve activity and participation.
Timepoint [1] 318599 0
Post 4 week program and 1 month follow up
Secondary outcome [1] 365486 0
Gross Motor Function Measure 88
The GMFM is a standard, valid and reliable evaluative measure to assess changes in gross motor skills over time in children with cerebral palsy. This 88 item, criterion based tool measures gross motor skills in five dimensions: (1) lying and rolling, (2) sitting, (3) crawling and kneeling, (4) standing and (5) walking, running and jumping. Each item is scored on a four point scale: 0= does not initiate, 1= initiates (less than 10% of the task), 2= partially completes (10% to less than 100% of the task), 3 = completes the task. Each item is described in full in the GMFM manual indicating starting position, and characteristics of each score for each of the 88 items.
Timepoint [1] 365486 0
Post 4 week program and 1 month follow up
Secondary outcome [2] 365487 0
Canadian Occupational Performance Measure (COPM) Performance Rating
This measure is client/family centered and is therefore the most suitable measure for activity and participation in this population. The COPM is valid, reliable and responsive to changes following intervention from the patient/family’s perspective. This enables parents to rate their perception of performance for their child.
Timepoint [2] 365487 0
Post 4 week program and 1 month follow up
Secondary outcome [3] 365488 0
10 metre walk test
The 10MWT will be used to measure self-selected walking speed. This test will be performed in the participants’s usual assistive mobility device. The 10MWT is chosen because of its specificity (assessment of walking) and is representative of the distances commonly needed i.e. within the home or classroom environment with high retest reliability. It is a commonly used outcome measure in many locomotor training studies.. A digital stop watch will be used to time the walk
Timepoint [3] 365488 0
Post 4 week program and 1 month follow up
Secondary outcome [4] 365489 0
Wee Functional Independence Measure
Timepoint [4] 365489 0
Post 4 week program and 1 month follow up
Secondary outcome [5] 365490 0
Exit Interview
A semi-structured interview will be conducted with parents and participants at the conclusion of their participation in the intervention. Semi-structured interviews will be conducted with treating therapists upon completion of the intervention. Interview guides specific to each group have been developed are based on the ICF. The guide contains questions and prompts designed to guide the interview in a focused, yet flexible manner. The 30 minute interview will be audio-recorded and then transcribed for thematic analysis.
Timepoint [5] 365490 0
Post 4 week program and 1 month follow up
Secondary outcome [6] 365491 0
Sleep Disturbance Scale
Timepoint [6] 365491 0
Post 4 week program and 1 month follow up
Secondary outcome [7] 365547 0
Infant Toddler Quality of Life
Timepoint [7] 365547 0
Post 4 week program and 1 month follow up
Secondary outcome [8] 365618 0
Peabody Developmental Motor Scales Version 2 (PDSM-2) - Fine motor quotient
Timepoint [8] 365618 0
Post 4 week program and 1 month follow up
Secondary outcome [9] 365782 0
The Canadian Occupational Performance Measure Satisfaction Rating.
Canadian Occupational Performance Measure (COPM) Performance Rating
This measure is client/family centered and is therefore the most suitable measure for activity and participation in this population. The COPM is valid, reliable and responsive to changes following intervention from the patient/family’s perspective. This enables parents to rate their perception of satisfaction for their child's ability.
Timepoint [9] 365782 0
Post 4 week program and 1 month follow up

Eligibility
Key inclusion criteria
• Children with neurologically based conditions and injuries (equivalent to GMFCS level III to V i.e. require equipment of physical assistance for mobility and may include mixed signs with dyskinesia, hypotonia, ataxia and hypertonia).
• Aged between 2 and 5 years.
• Have multi-disciplinary goals that are based on improving participation through mobility, socialising and upper limb functional readiness.
Minimum age
2 Years
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Orthopaedic surgery in the past 6 months.
• Unstable hip subluxation.
• Engaged in locomotor training in the last month.
• Uncontrolled seizure disorder.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility trial determining acceptability, limited efficacy testing, practicality, implementation and demand.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
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, standard deviations and 95% confidence intervals at each assessment time point reported. For ordinal data, or where data is normally distributed despite transformations, non-parametric tests will be applied with medians and interquartile ranges reported. Intention to treat analysis will be applied.
Clinically meaningful change will be calculated for the Canadian Occupational Performance Measure where each individual participant will be assessed for meaningful change (score change of > 2). For the GMFM, upper and lower confidence intervals will be reviewed for overlap. The proportion of confidence intervals that do not overlap between assessments will be considered true change.
All data will be analysed using Stata 14.1 (StataCorp, College Station, TX). Statistical significance will be considered at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301577 0
Charities/Societies/Foundations
Name [1] 301577 0
Telethon Trust
Address [1] 301577 0
PO Box 1777 Osborne Park DC WA 6916
Country [1] 301577 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Healthy Strides Foundation
Address
Unit 4, 31 Archer Street Carlisle, 6101 WA
Country
Australia
Secondary sponsor category [1] 301275 0
None
Name [1] 301275 0
Address [1] 301275 0
Country [1] 301275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302306 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 302306 0
Kent Street Bentley, Perth, Western Australia 6102
Ethics committee country [1] 302306 0
Australia
Date submitted for ethics approval [1] 302306 0
18/01/2019
Approval date [1] 302306 0
19/02/2019
Ethics approval number [1] 302306 0
HRE2019-0073

Summary
Brief summary
For primary school aged children with neurologically based conditions requiring high level of support and care, locomotor training (walk training) appears to be a feasible intervention to improving functional mobility. For younger children, engagement is critical so interventions need to be functionally meaningful and immersed within an activity based framework that encourages play and participation. This is particularly important as children prepare to go to kindy or preprimary school. Given the acceptability of intensive locomotor training for school aged children with cerebral palsy and the importance of early intervention for children with neurologically based conditions and injuries, this research project aims to investigate if locomotor training immersed in an activity based framework is equally as feasible in children with neurologically based conditions and injuries aged between 2 and 5 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89766 0
Dr Dayna Pool
Address 89766 0
The Healthy Strides Foundation
Unit 4, 31 Archer Street Carlisle WA 6101
Country 89766 0
Australia
Phone 89766 0
+61422472622
Fax 89766 0
Email 89766 0
daynapool@healthystridesfoundation.com
Contact person for public queries
Name 89767 0
Dr Dayna Pool
Address 89767 0
The Healthy Strides Foundation
Unit 4, 31 Archer Street Carlisle WA 6101
Country 89767 0
Australia
Phone 89767 0
+61422472622
Fax 89767 0
Email 89767 0
daynapool@healthystridesfoundation.com
Contact person for scientific queries
Name 89768 0
Dr Dayna Pool
Address 89768 0
The Healthy Strides Foundation
Unit 4, 31 Archer Street Carlisle WA 6101
Country 89768 0
Australia
Phone 89768 0
+61422472622
Fax 89768 0
Email 89768 0
daynapool@healthystridesfoundation.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results