Skip to main content
OpenTrials
Completed

NCT Number: NCT05346887

Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Perinatal Stroke

Age range

3 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Satisfaction of therapists

    Time frame: <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.

  2. Canadian Occupational Performance Measure (COPM)

    Time frame: <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.

  3. Age-appropriate hand assessment (HAI/mini-AHA/AHA)

    Time frame: <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 outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

  2. Age-appropriate hand assessment (HAI/mini-AHA/AHA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: HEIGHTEN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.