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Baby LE-CIMT (Baby Lower Extremity Constraint Induced Movement Therapy): a feasibility study in infants and toddlers with unilateral cerebral palsy

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000189527
Acronym
Baby LE-CIMT
Enrollment
50
Registered
2024-02-27
Start date
2024-04-01
Completion date
2026-04-01
Last updated
2024-03-04

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 use of constraint-induced movement therapy in the upper limb is now a renowned ‘green light’ therapy for the treatment of children living with cerebral palsy where one side of their body is affected (unilateral cerebral palsy - UCP). This involves constraining the non-affected upper limb with a mitt or a splint in order to encourage targeted use of the affected limb to improve function. Currently, however, there are no well researched interventions targeted at the lower limb of infants and toddlers living with cerebral palsy, despite the knowledge that independence in gross motor skill acquisition positively affects cognitive development and the timing of critical window of motor neuronal development. We wish to investigate the feasibility and acceptability of this intervention on infants and toddlers, 10-18 months of age living with unilateral cerebral palsy. The key objectives of this research study include: 1. Is Baby Lower Extremity Constraint Induced Movement Therapy (Baby LE-CIMT) feasible for carers and therapists and acceptable to referrers of infants and toddlers with unilateral cerebral palsy? 2. What is the effect of Baby LE-CIMT on gross motor function, cognitive function, muscle volume and gait parameters in infants and toddlers with UCP?

Interventions

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 uni

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.

Sponsors

Dr Cathy Morgan
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
10 Months to 18 Months
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026