Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

Study Overview
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Brief Summary
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The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.

Official Title
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Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

Conditions
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Cerebral Palsy, Perinatal Stroke

Intervention / Treatment
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* Behavioral: Home-based Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged three to 24 months (corrected, if premature) clinician-identified hand asymmetry suspected/confirmed cerebral palsy (hemiplegia or triplegia) willing to withhold other formal upper-limb focussed treatment during the study intervention - willing to commit to completing 18 weeks of daily home-practice and attending weekly therapy sessions. Exclusion Criteria: participation in formal constraint induced movement therapy (CIMT) within last six months upper limb botulinum toxin A injections within previous six months brachial plexus injury lower motor neuron dysfunction upper limb congenital limb difference.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based Therapy<br> | Behavioral: Home-based Therapy<br>* The 18-week caregiver-delivered intervention involves daily 30-minute home-practice and weekly sessions with a therapist over video call or in-person at a local rehabilitation centre. During weekly sessions, the therapist will coach the caregiver(s), problem-solving with them and supporting their autonomy as agents of change in their child's care. The first 13-weeks of the program will be exclusively constraint-induced movement therapy, with bimanual therapy introduced in the last five weeks depending on child age. Intervention content will be individualized based on child age, ability, and interests.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of therapists | Satisfaction with the intervention will be assessed using a study-built questionnaire with Likert-scale response options 0 to 4, with 4 being greater satisfaction. | <7 days after the 18-week intervention | 
| Canadian Occupational Performance Measure (COPM) | Using the COPM, three to five individualized functional goals will be identified by caregivers and then scored on a scale of 1 to 10 for both Performance and Satisfaction. | <7 days after the 18-week intervention | 
| Age-appropriate hand assessment (HAI/mini-AHA/AHA) | The HAI/mini-AHA/AHA employ a video-recorded play-based session of <15 minutes to provide a logit-based measure of manual function. | <7 days after the 18-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure (COPM) | Using the COPM, three to five individualized functional goals will be identified by caregivers and then scored on a scale of 1 to 10 for both Performance and Satisfaction. | 8 weeks +/-3days after the the 18-week intervention. | 
| Age-appropriate hand assessment (HAI/mini-AHA/AHA) | The HAI/mini-AHA/AHA employ a video-recorded play-based session of <15 minutes to provide a logit-based measure of manual function. | 8 weeks +/-3days after the the 18-week intervention. |