Back to resultsHome-based Early Intensive Hemiparesis Therapy: Engaging Nurture (HEIGHTEN)
Primary Purpose
Cerebral Palsy, Perinatal Stroke
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home-based Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
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.
Sites / Locations
- University of Calgary
- University of Alberta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home-based Therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05346887
Brief Title
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
Acronym
HEIGHTEN
Official Title
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Perinatal Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-based Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Home-based Therapy
Intervention Description
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 Outcome Measure Information:
Title
Satisfaction of therapists
Description
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.
Time Frame
<7 days after the 18-week intervention
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
<7 days after the 18-week intervention
Title
Age-appropriate hand assessment (HAI/mini-AHA/AHA)
Description
The HAI/mini-AHA/AHA employ a video-recorded play-based session of <15 minutes to provide a logit-based measure of manual function.
Time Frame
<7 days after the 18-week intervention
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
8 weeks +/-3days after the the 18-week intervention.
Title
Age-appropriate hand assessment (HAI/mini-AHA/AHA)
Description
The HAI/mini-AHA/AHA employ a video-recorded play-based session of <15 minutes to provide a logit-based measure of manual function.
Time Frame
8 weeks +/-3days after the the 18-week intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
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