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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks +/-3days after the the 18-week intervention.
Awards & highlights
HEIGHTEN Trial 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.Check my eligibility
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.See study design
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.
HEIGHTEN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 3 to 24 months old.
Select...
I am willing to do daily practice at home and attend weekly therapy for 18 weeks.
Select...
I have been diagnosed with cerebral palsy, affecting one side of my body or three limbs.
Select...
I agree not to undergo other upper-limb treatments during the study.
HEIGHTEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks +/-3days after the the 18-week intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks +/-3days after the the 18-week intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Satisfaction of therapists
Secondary outcome measures
Age-appropriate hand assessment (HAI/mini-AHA/AHA)
Canadian Occupational Performance Measure (COPM)
HEIGHTEN 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
791 Previous Clinical Trials
868,714 Total Patients Enrolled
3 Trials studying Perinatal Stroke
132 Patients Enrolled for Perinatal Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Issues with the nerves that control movement.My child is between 3 to 24 months old.I am willing to do daily practice at home and attend weekly therapy for 18 weeks.I have been diagnosed with cerebral palsy, affecting one side of my body or three limbs.You were born with a difference in your upper limb.Your doctor has noticed that one hand looks different from the other.I agree not to undergo other upper-limb treatments during the study.I have an injury to the nerves in my shoulder.I have not participated in CIMT in the last 6 months.I have had botulinum toxin A injections in my arm in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what demographic is enrollment in this experiment open?
"This research project is open to children between 3 Months and 24 Months with perinatal stroke. There are 20 available slots in the study."
Answered by AI
Are individuals above the age of 25 able to participate in this experiment?
"This study can only accept subjects between 3 Months and 24 Months of age. Specifically, 147 clinical trials are accepting minors while 91 are open to applicants over the age 65."
Answered by AI
How many participants are currently being accepted into this research trial?
"Affirmative. Research hosted on clinicaltrials.gov suggest that recruitment is still ongoing for this experiment, which was initially made public on May 1st 2022 and amended most recently on November 1st 2022. Thus far, 20 individuals have been recruited from 2 distinct medical centres."
Answered by AI
Are any more participants being admitted to this experiment?
"The information hosted on clinicaltrials.gov attests that this medical trial is recruiting participants at the moment. This investigation, which was initially advertised on May 1st 2022, has been modified for the last time in November of the same year."
Answered by AI
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