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Best Start Trial: early intervention physiotherapy to improve motor outcomes in infants at high risk of cerebral palsy or motor delay

Does parent administered physiotherapy delivered to preterm/term infants at high risk of CP or motor delay improve motor outcomes at 16 weeks corrected age compared to usual care?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000847112
Enrollment
30
Registered
2019-06-14
Start date
2019-09-09
Completion date
2021-10-27
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Best Start Trial aims to determine whether targeted physiotherapy interventions initiated up to 4-5 months earlier than typically commenced (3 months corrected age), will improve motor outcomes at the 16 week time point in infants at risk of cerebral palsy or motor delay. Parents or caregivers will be closely coached by physiotherapists in the provision of targeted motor interventions to their infant, commencing as early as 34 weeks gestational age until their infant is 16 weeks old. The motor outcomes of infants receiving the parent administered physiotherapy or motor therapy will be compared to current "usual care" to determine if either of these approaches is more beneficial than the other. It is hypothesised that the parent-administered approach will be more beneficial than "usual care" because of it's targeted physiotherapy content and improved continuity of physiotherapy delivery from the NICU to home.

Interventions

Experimental: Best Start Intervention. The essential elements of the experimental intervention include: (i) Physiotherapy Motor Training. Following individualised assessment of the infant, motor goals are discussed with the parents including head control, orientation of movements to the midline and eye-hand co-ordination. From the assessment, the infant’s individual limitations to attaining these goals are explained. Training is designed for the infants individual needs to target goal achievemen

Experimental: Best Start Intervention. The essential elements of the experimental intervention include: (i) Physiotherapy Motor Training. Following individualised assessment of the infant, motor goals are discussed with the parents including head control, orientation of movements to the midline and eye-hand co-ordination. From the assessment, the infant’s individual limitations to attaining these goals are explained. Training is designed for the infants individual needs to target goal achievement and to be parent-administered. Experimental care interventions will involve the infant actively and repeatedly practicing movements in response to a parent stimulus or toy that provokes intentional active movement to achieve early motor milestone goals. Emphasis is placed on providing optimal motor learning opportunities without tiring their infant. Parents will be educated on how to read their infants behavioural cues to prevent this. The earliest age infants will commence motor training is 34 weeks GA as this has been identified as a time when infants can comfortably tolerate short periods of motor learning without detriment. Infants will regularly be reassessed to inform the infants motor learning needs. (ii) Parent Coaching in Motor Training: In the NICU and SCN, parents are coached in how to provide short periods (ie 5 minutes maximum three times per day) of motor training in the infants care time ie 30 mins before a feed when nappy changes and other routine cares are performed. Coaching involves helping parents practice activities which illicit motor goals whilst maintaining awareness of their infant’s behavioural cues. Activities will be selected which best suit the parents’ abilities and the infants’ needs. Coaching is therefore parent responsive and aims to support and optimise parent mental health, empowerment and attachment. It is also adapted to the infant’s family’s culture, education and parenting style. Coaching sessions will occur 1-2 times per week as indicated. On discharge home, further parent coaching will be performed by the experimental care physiotherapist. This will occur through home visits, clinic appointments and Skype© sessions on fortnightly – monthly basis as indicated. The duration of motor therapy sessions provided at home initially is three times 10 minutes per day delivered when the infant is alert and awake. By 16 weeks corrected age each of the three sessions will increase from 10 to 20 minutes. Handouts will be provided with photographs, illustrations and instructions to support the therapy content and dosage to be administered by the parent/caregiver. Contacts for the experimental care physiotherapists will be provided to assist with any queries external to coaching times. (iii) Environment Enrichment Strong evidence exists for the provision of environmental enrichment strategies to advance motor development which includes consideration of motor, cognitive, sensory and social domains. Experimental care incorporates each of these aspects as follows with modifications as pertinent between the hospital and home environment: a) Physical environment: provision of physical supports to promote movement eg creating nests, use of a supportive baby chair (Fraser chair) and the use of activities and materials (baby play gym and initial baby toys such as rattles and rings) to entice desired movements b) Cognitive environment: by encouraging early infant problem solving such as hand sucking to functionally self-settle c) Sensory environment: by providing the best background for enhancing motor learning capacity considering timing of therapy delivery with sleep, feeding, oxygen requirements and pain management so that the infant is alert, settled and happily able to best engage. d) Social environment: by coaching parents to be sensitive, responsive and communicative to infant cues. The mechanism of home visits will enable environmental enrichment strategies to be set up in the natural home environment through parent coaching. As this is where the majority of the experimental care interventions will occur, this will enable the translation of practice with is specific, relevant and at the appropriate intensity for the infant to achieve identified motor goals. Prior to discharge home, when the infant is still admitted in the NICU, efforts will be made to enrich the infant’s environment as much as possible within the hospital environment.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to 16 Weeks
Healthy volunteers
No

Inclusion criteria

The key inclusion criteria are (i) Infants deemed at risk of CP and (ii) parents likely to uptake parent-administered interventions for their infants and (iii) infants deemed likely to benefit from motor learning interventions. The criteria for eligibility include: 1. Any preterm or term Infant with other identifiable risk factors such as (i) Grade 3 or 4 intra-ventricular haemorrhage (IVH), periventricular leukomalacia (PVL) and cystic PVL, periventricular infarction, lesions of the basal ganglia and thalamus, unilateral parenchymal injury, cortical malformation or other MRI identified brain injury eg ischaemic injury (ii) seizures (iii) significant post-natal infections infection such as meningitis, blood culture positive gram negative septicaemia or other congenitial TORCH infections (Toxoplasmosis, other [syphilis, varicella-zoster, parvovirus B19], Rubella, Cytomegalovirus (CMV), and Herpes infections). (iv) chronic lung disease (CLD) who received post-natal dexamethasone (v) Intra-uterine growth retardation (IUGR) = 3rd centile. (vi) Abnormal General Movements assessment scoring cramped synchronous at term age in the “Writhing movements” period 2. Term infants with hypoxic ischaemic encephalopathy (HIE): Sarnat Stage 2 (moderate) or Sarnat Sage 3 (severe) or MRI identified brain injury 3. Preterm infants less than or equal to 27+6 weeks gestational age.

Exclusion criteria

Exclusion criteria: 1. Parents unable to understand and speak English. 2. Infants with syndromes, cortical visual impairment (detected using the RICCI scale). 3. Retinopathy of Prematurity (ROP) Grade 3. 4. Significant auditory impairment. 5. Infants having undergone major surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026