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Behavioral Intervention

Home-Based Therapy for Cerebral Palsy (HEIGHTEN Trial)

N/A
Waitlist Available
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged three to 24 months (corrected, if premature)
Willing to commit to completing 18 weeks of daily home-practice and attending weekly therapy sessions
Must not have
Brachial plexus injury
Upper limb botulinum toxin A injections within previous six months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks +/-3days after the the 18-week intervention.
Awards & highlights
No Placebo-Only Group

Summary

This trialtests if a caregiver-led program can help babies and toddlers with cerebral palsy reach their developmental goals.

Who is the study for?
This trial is for infants and toddlers aged three to 24 months with suspected or confirmed cerebral palsy, specifically hemiplegia or triplegia. They should have hand asymmetry identified by a clinician and be willing to engage in daily home-based therapy without other upper-limb treatments for 18 weeks.
What is being tested?
The study tests the effectiveness of a caregiver-delivered rehabilitation program designed for young children with cerebral palsy at home. It aims to see how well families can implement this therapy and its impact on the child's condition.
What are the potential side effects?
Since this intervention involves physical therapy exercises conducted at home under caregiver supervision, side effects may include typical discomforts related to physical activity such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 3 to 24 months old.
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I am willing to do daily practice at home and attend weekly therapy for 18 weeks.
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I have been diagnosed with cerebral palsy, affecting one side of my body or three limbs.
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I agree not to undergo other upper-limb treatments during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an injury to the nerves in my shoulder.
Select...
I have had botulinum toxin A injections in my arm in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks +/-3days after the the 18-week intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks +/-3days after the the 18-week intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Satisfaction of therapists
Secondary study objectives
Age-appropriate hand assessment (HAI/mini-AHA/AHA)
Canadian Occupational Performance Measure (COPM)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Home-based TherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
810 Previous Clinical Trials
886,274 Total Patients Enrolled
9 Trials studying Cerebral Palsy
380 Patients Enrolled for Cerebral Palsy

Media Library

Home-based Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05346887 — N/A
Cerebral Palsy Research Study Groups: Home-based Therapy
Cerebral Palsy Clinical Trial 2023: Home-based Therapy Highlights & Side Effects. Trial Name: NCT05346887 — N/A
Home-based Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05346887 — N/A
~6 spots leftby Dec 2025
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