Cerebral Palsy Clinical Trial
— HEIGHTENOfficial title:
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
Verified date | November 2023 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 24 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | |
Secondary | 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. |
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