Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture (HEIGHTEN)

November 29, 2023 updated by: University of Calgary
The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 2 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
<7 days after the 18-week intervention
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.
<7 days after the 18-week intervention
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.
<7 days after the 18-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks +/-3days after the the 18-week intervention.
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.
8 weeks +/-3days after the the 18-week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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