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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05346887
Other study ID # 21-1981
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 2024

Study information

Verified date November 2023
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 3 Months to 24 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada University of Calgary Calgary Alberta
Canada University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. <7 days after the 18-week intervention
Primary 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. <7 days after the 18-week intervention
Primary 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. <7 days after the 18-week intervention
Secondary 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. 8 weeks +/-3days after the the 18-week intervention.
Secondary 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. 8 weeks +/-3days after the the 18-week intervention.
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