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

Sponsor
University of Calgary (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05346887
Collaborator
(none)
20
Enrollment
1
Arm
19
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Home-based Therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Satisfaction of therapists [<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) [<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) [<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 Outcome Measures

  1. Canadian Occupational Performance Measure (COPM) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Calgary

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT05346887
Other Study ID Numbers:
  • 21-1981
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cerebral Palsy
Paresis

Study Results

No Results Posted as of Apr 29, 2022