ANZCTR - Registration

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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

8/02/2021

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Cerebral palsy

Acquired brain injuries

Spinal cord injuries

Lissencephaly

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

Occupational therapy

Physical Medicine / Rehabilitation

Speech therapy

Neurological

Other neurological disorders

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Injuries and Accidents

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]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]