Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

Not Applicable

Active, not recruiting

• Conditions: Cerebral Palsy; Perinatal Stroke

• Registration Number: NCT05346887
• Lead Sponsor: University of Calgary

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-26
• Study Start: 2022-05-01
• Primary Completion: 2024-04-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Satisfaction of therapists	<7 days after the 18-week intervention	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.
Canadian Occupational Performance Measure (COPM)	<7 days after the 18-week intervention	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.
Age-appropriate hand assessment (HAI/mini-AHA/AHA)	<7 days after the 18-week intervention	The HAI/mini-AHA/AHA employ a video-recorded play-based session of \<15 minutes to provide a logit-based measure of manual function.

Secondary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	8 weeks +/-3days after the the 18-week intervention.	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.
Age-appropriate hand assessment (HAI/mini-AHA/AHA)	8 weeks +/-3days after the the 18-week intervention.	The HAI/mini-AHA/AHA employ a video-recorded play-based session of \<15 minutes to provide a logit-based measure of manual function.

Trial Locations

Locations (2)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada