Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

NCT05346887 | Completed

• 1 other identifier: 21-1981
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Perinatal Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

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

• Age-appropriate hand assessment (HAI/mini-AHA/AHA)

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

Study Arms (1)

Home-based Therapy

EXPERIMENTAL

Behavioral: Home-based Therapy

Interventions

Home-based Therapy BEHAVIORAL

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.

Home-based Therapy

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: April 28, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)