Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000189527p
Ethics application status
Submitted, not yet approved
Date submitted
16/01/2024
Date registered
27/02/2024
Date last updated
27/02/2024
Date data sharing statement initially provided
27/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Baby LE-CIMT (Baby Lower Extremity Constraint Induced Movement Therapy): a feasibility study in infants and toddlers with unilateral cerebral palsy
Scientific title
The feasibility and acceptability of Baby Lower Extremity Constraint Induced Movement Therapy (Baby LE-CIMT) in infants and toddlers with unilateral cerebral palsy. A pragmatic Randomised Controlled Trial.
Secondary ID [1] 311301 0
Nil known
Universal Trial Number (UTN)
U1111-1302-5351
Trial acronym
Baby LE-CIMT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 332546 0
Condition category
Condition code
Neurological 329234 329234 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 329235 329235 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those participants allocated to the intervention arm of the study will receive 12 weeks of Baby LE-CIMT (Lower Extremity-Baby Constraint Induced Movement Therapy) with 4 distinct elements.
1. Task Specific, goal directed intervention
Baby LE-CIMT is constraint therapy intervention applied to the lower extremity. In order to promote the use of the affected lower extremity; a chosen constraint will be applied to the non-affected limb in children with unilateral or at ‘high risk’ of developing unilateral cerebral palsy. The constraint and the activity chosen will be dependent on the family's chosen participation goals and the child's impairment and neurological insult aetiology.
For instance if the child's goal was to walk independently with a trolley for a distance of 5 metres indoors, this may include the use of a leg wrap on their affected limb whilst walking with a trolley indoors.
Dosage
Those allocated to the intervention arm will receive Baby LE-CIMT via weekly 1 hour home visits in addition to standard care by their relevant therapy team; this will include coaching by the study therapist within this time. In addition to the weekly home visits they will be advised to perform a minimum of 30 mins of home practice on a further 5 days of the week.
The total dosage over the intervention period will therefore be a minimum of 42 hours (this includes 12 x 1 hour home visit sessions + 5 days per week of 30 minute sessions x 12 weeks).
2. Task Specific Training in Meaningful environmental contexts
Baby LE-CIMT will be provided within the child's own home and community setting. The study physiotherapist will empower the child's family members to create a supportive physical environment to implement each task-specific activity with age and developmentally appropriate toys and equipment
3. Shaping and Coaching
The study therapist will empower the family's knowledge and skill in performing Baby LE-CIMT with their child. As the week progresses and the parent's skill and understanding enhances; the parent should be increasingly encouraged to develop the next activity progressions with prompting from motivational interviewing techniques from the therapist. Shaping strategies to enable generalisation and transfer to every day play situations will also be used.
4. Collaborative generation of a home exercise program
A set of 2-3 activities to focus on that relate back to the caregiver's goals will be established each week between the study therapist and the caregiver. Videos of the exercises each week will be uploaded into an application program that can be accessed via a smart phone or a web browser. In order to monitor adherence to the intervention, caregivers will then be able to tick the exercises that have been completed daily and include duration and any comments that they have. Caregivers are also encouraged to complete a log of weekly physical activities in addition to the prescribed intervention. This weekly activity log will be completed by children in the standard care and intervention arm.
Intervention code [1] 327749 0
Rehabilitation
Comparator / control treatment
Standard care:
Those participants who are randomised to the standard care group will continue to receive their usual care throughout the study period. This includes the active follow up and therapeutic rehabilitation that an infant or a toddler receives after acquiring a diagnosis of cerebral palsy or at 'high risk' of developing cerebral palsy. The dosage, type and intensity of standard care physiotherapy greatly differs throughout NSW and within and outside of Australia. 'Standard care' will also vary greatly dependent on whether the child is receiving intervention via the Australian health care system or under the National Disability Insurance Scheme (NDIS). The content of the standard care intervention will be recorded via a questionnaire for treating therapists.
Control group
Active

Outcomes
Primary outcome [1] 337394 0
Acceptability
Timepoint [1] 337394 0
2 years post recruitment commencement
Primary outcome [2] 337395 0
Feasibility
Timepoint [2] 337395 0
This will be assessed at 14 weeks post intervention commencement.
Secondary outcome [1] 430575 0
Gross Motor Function
Timepoint [1] 430575 0
Reviewed at baseline, 14 weeks post intervention commencement and at 6 months post-baseline
Secondary outcome [2] 430576 0
Gross Motor Function
Timepoint [2] 430576 0
Reviewed at baseline, 14 weeks post intervention commencement and at 6 months post-baseline.
Secondary outcome [3] 430577 0
Cognition
Timepoint [3] 430577 0
Baseline, 14 weeks post intervention commencement and 6 months post-baseline
Secondary outcome [4] 430578 0
Goal attainment
Timepoint [4] 430578 0
Baseline and 14 weeks post intervention commencement
Secondary outcome [5] 430580 0
Muscle Volume
Timepoint [5] 430580 0
Baseline, 14 weeks post intervention commencement and 6 months post-baseline
Secondary outcome [6] 430581 0
Gait Analysis
Timepoint [6] 430581 0
Between group differences at 6 months post baseline
Secondary outcome [7] 430582 0
Severity Modifier
Timepoint [7] 430582 0
Baseline, 14 weeks post intervention commencement, 6 months post-baseline measures

Eligibility
Key inclusion criteria
i. Children 10-18 months of age (corrected for prematurity) with a diagnosis of “high risk” of unilateral cerebral palsy with at least 2 of the items below:
a. Unilateral brain lesion (including but not limited to IVH, ischaemic stroke) as identified on MRI or cranial ultrasound
b. "Absent Fidgety"/ "Asymmetric Fidgety General Movements"
c. Clinician or parent report of reduced and asymmetric lower limb function
d. Hammersmith Infant Neurological Examination (HINE) of 40 or greater with 4 or more congruent asymmetries.
Minimum age
10 Months
Maximum age
18 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Presence of refractory seizures
ii. Severe Visual Impairment (eg severe Cerebral Visual Impairment)
iii. Clinical Signs of Bilateral injury (Eg Bilateral periventricular leukomalacia (PVL), basal ganglia or thalamic pattern of injury)
iv. Extensive musculoskeletal impairments
v. Botulinum toxin injections or surgery in the lower extremity in the preceding 6 months
vi. Nil English-speaking caregivers
vii. Geographical location falls outside feasible travel distance for study interventionists

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)
After consent and baseline measures are obtained, each infant will be randomised into either the Baby LE-CIMT (n=25) (in addition to SC) or into the SC group (n=25) from concealed allocation using a REDCAP randomization module, established by non-study personnel. Outcome of the randomisation will be distributed to participants via concealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer generated using a REDCAP randomisation module, established by non-study personnel. Randomisation will be stratified by age to ensure equal numbers of ‘pre-walkers’ and ‘walkers’ are in each group.
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 primary outcome assesses the feasibility and acceptability of Baby LE-CIMT with acceptability being assessed via the total number of participants recruited to each arm. Feasibility will be assessed by calculating the number of intervention sessions completed via a physiotherapy app; Physiapp and via a qualitative questionnaire.
Although improvement in gross motor function is not the primary aim of this study, we note that the proposed sample size would also be sufficient to detect a moderate effect size (Cohen’s d = 0.5) of the intervention on improvement on the GMFM-66 in a baseline adjusted linear regression model for between group differences with >80% power at the 5% significance level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
14/01/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25998 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 25999 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 26000 0
Wollongong Hospital - Wollongong
Recruitment hospital [4] 26001 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 26002 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 26003 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [7] 26004 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 26005 0
Nepean Hospital - Kingswood
Recruitment hospital [9] 26007 0
Royal Hospital for Women - Randwick
Recruitment hospital [10] 26008 0
Bowral Hospital - Bowral
Recruitment postcode(s) [1] 41847 0
2145 - Westmead
Recruitment postcode(s) [2] 41848 0
2031 - Randwick
Recruitment postcode(s) [3] 41849 0
2500 - Wollongong
Recruitment postcode(s) [4] 41850 0
2560 - Campbelltown
Recruitment postcode(s) [5] 41851 0
2065 - St Leonards
Recruitment postcode(s) [6] 41852 0
2050 - Camperdown
Recruitment postcode(s) [7] 41853 0
2170 - Liverpool
Recruitment postcode(s) [8] 41854 0
2747 - Kingswood
Recruitment postcode(s) [9] 41855 0
2576 - Bowral

Funding & Sponsors
Funding source category [1] 315554 0
Charities/Societies/Foundations
Name [1] 315554 0
Cerebral Palsy Alliance
Country [1] 315554 0
Australia
Primary sponsor type
Individual
Name
Dr Cathy Morgan
Address
187 Allambie Rd, Allambie Heights NSW 2100
Country
Australia
Secondary sponsor category [1] 317686 0
None
Name [1] 317686 0
Address [1] 317686 0
Country [1] 317686 0
Other collaborator category [1] 282927 0
Individual
Name [1] 282927 0
Dr Sian Williams
Address [1] 282927 0
Optional
Country [1] 282927 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314453 0
Sydney Children's Hospitals Network Human Research Ethics Committee (SCHN HREC)
Ethics committee address [1] 314453 0
Ethics committee country [1] 314453 0
Australia
Date submitted for ethics approval [1] 314453 0
13/02/2024
Approval date [1] 314453 0
Ethics approval number [1] 314453 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131638 0
Mrs Stephanie Taylor
Address 131638 0
The Little Physio, 112B Railway St, Corrimal, NSW, 2518, Australia
Country 131638 0
Australia
Phone 131638 0
+61 2 4249 4155
Fax 131638 0
Email 131638 0
[email protected]
Contact person for public queries
Name 131639 0
Stephanie Taylor
Address 131639 0
The Little Physio, 112 B Railway St, Corrimal, NSW, 2518, Australia
Country 131639 0
Australia
Phone 131639 0
+61 2 4249 4155
Fax 131639 0
Email 131639 0
[email protected]
Contact person for scientific queries
Name 131640 0
Stephanie Taylor
Address 131640 0
The Little Physio, 112 B Railway St, Corrimal, NSW, 2518, Australia
Country 131640 0
Australia
Phone 131640 0
+61 2 4249 4155
Fax 131640 0
Email 131640 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.