None listed
Conditions
Brief summary
This multisite study will compare infant friendly modified constraint induced movement therapy to infant friendly bimanual therapy for infants with asymmetric brain injuries.
Interventions
Infant-friendly modified constraint induced movement therapy (mCIMT) involves wearing a material glove/sock on the unimpaired hand to encourage use of the impaired hand in play based activity with the impaired arm/hand. mCIMT will be provided in the home by parents/caregivers to the infant by using the glove/sock and engaging the infant in specific play based activities. mCIMT will commence between 3-9 months corrected age, and be provided for 20 minutes per day (can be done in 2 by 10 minute bl
Infant-friendly modified constraint induced movement therapy (mCIMT) involves wearing a material glove/sock on the unimpaired hand to encourage use of the impaired hand in play based activity with the impaired arm/hand. mCIMT will be provided in the home by parents/caregivers to the infant by using the glove/sock and engaging the infant in specific play based activities. mCIMT will commence between 3-9 months corrected age, and be provided for 20 minutes per day (can be done in 2 by 10 minute blocks) for 5 days per week up to 6 months of age. Between 6 and 9 months of age, therapy will be provided for 30 minutes per day (can be done in 3 by 10 minute blocks) for 5 days per week. Between 9 and 12 months of age, therapy will be provided for 40 minutes per day (can be done in 2 by 20 minute blocks) for 5 days per week. Between 12 and 15 months of age, therapy will be provided for 40 minutes per day (can be done in 2 by 20 minute blocks) for 5 days per week. Parents will be supported by an experienced occupational therapist/physiotherapist who do regular monthly home visits and fortnightly Skype calls for 6 months until the infant is 12-15 months of age to ensure that therapy is child and family friendly. Parents will document the intervention in a training log, and therapists will videorecord home visit therapy sessions.
Sponsors
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Months to 9 Months
Healthy volunteers
No
Inclusion criteria
Participants will be recruited between 3 and 9 months corrected age (+14 days) and have English spoken in the family AND have the following by less than or equal to 9 months c.a: 1. Asymmetric brain lesion identified on CUS or MRI including asymmetric (one sided or more involved on one side) or unilateral brain injury including preterm or term arterial stroke, grade III or IV intraventricular haemorrhage, asymmetric periventricular leukomalacia or asymmetric deep grey matter (DGM) lesions; AND/OR 2 (a). Absent Fidgety Movements on General Movements Assessment at 12 weeks C.A. by direct video or uploaded using Baby Moves App (2 part consent for screening then recruitment) (including Asymmetric Fidgety whom are often later diagnosed with hemiplegia) AND/OR 2 (b). Abnormal Hammersmith Infant Neurological Examination (HINE) between 18 to 39 weeks AND 3. Asymmetry of upper limb reach and/or grasp on the Hand Assessment of Infants (> 3 point difference) that is congruent with the brain injury (opposite to likely side of the lesion) In the absence of 1 participants must have 2(a) AND/OR 2(b). All participants must have 3.
Exclusion criteria
1. Epilepsy uncontrolled by medication as this would be a confounder. 2. Infants with Retinopathy of Prematurity (ROP) > grade 2 will be excluded. 3. Infants with Cortical blindness will be excluded. 4. Infants with ventriculo-peritoneal shunts will be excluded. 5. Asymmetric lesions that are NOT likely to be affecting the Corticospinal Tract (i.e. not affecting the Posterior Limb of the Internal Capsule or the Pyramids, or the motor cortex), such as tiny lesions of the cerebellum or the occipital pole, etc.
Outcome results
None listed