Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

Cerebral Palsy Clinical Trial

— HEIGHTEN  

Official title:

Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05346887
• Other study ID #: 21-1981
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paresis
• Perinatal Stroke

Intervention

Behavioral:
• Home-based Therapy
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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

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.