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Clinical Trials/NCT05346887
NCT05346887
Completed
Not Applicable

Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

University of Calgary2 sites in 1 country20 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Home-based Therapy
Conditions
Cerebral Palsy
Sponsor
University of Calgary
Enrollment
20
Locations
2
Primary Endpoint
Satisfaction of therapists
Status
Completed
Last Updated
4 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
April 4, 2024
Last Updated
4 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Home-based Therapy

Intervention: Home-based Therapy

Outcomes

Primary Outcomes

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.

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.

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

  • 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 Sites (2)

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