Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

N/AActive Not RecruitingNCT05346887

University of Calgary20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Palsy Perinatal Stroke

Interventions

Home-based TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (2)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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.

Time frame: <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.

Time frame: <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.

Time frame: <7 days after the 18-week intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: 8 weeks +/-3days after the the 18-week intervention.

Data from ClinicalTrials.gov

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