Home-Based Therapy for Cerebral Palsy

(HEIGHTEN Trial)

Not currently recruiting at 1 trial location

Overseen By Alicia Hilderley, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Botulinum toxin

Disqualifiers: Brachial plexus injury, lower motor neuron dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a home-based therapy program for young children with cerebral palsy, a condition affecting movement and coordination. The program involves caregivers working with their children at home to enhance the use of their hands and arms. It targets infants and toddlers, aged three to 24 months, who show signs of cerebral palsy and hand asymmetry (favoring one hand over the other). Families must commit to daily practice at home and attend weekly therapy sessions. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance early intervention strategies for cerebral palsy.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must not participate in other formal upper-limb treatments during the study.

What prior data suggests that this home-based therapy is safe for infants and toddlers with cerebral palsy?

Research has shown that home-based therapy for children with cerebral palsy is generally safe and well-tolerated. Studies have found these caregiver-guided therapies to be practical and effective. For instance, one study examined home-based brain stimulation and found it safe and manageable for children. Another study on simple home exercises, such as pediatric massage, supported these findings.

The evidence suggests that home-based therapies offer a good option for children with cerebral palsy, with minimal risk of side effects. This makes them a safe choice for families considering participation in a clinical trial focused on these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cerebral palsy that often require visits to specialized clinics, home-based therapy is unique because it allows families to integrate therapeutic exercises into their daily routines at home. This approach can make therapy more accessible, reduce the need for travel, and potentially increase the consistency of treatment. Researchers are excited about this method because it empowers caregivers to actively participate in the therapy process, which may enhance the child's progress and overall quality of life.

What evidence suggests that home-based therapy is effective for cerebral palsy?

Research shows that therapy done at home can help children with cerebral palsy. Studies have found that these programs can improve how children move and function. For example, one study found that training focused on specific goals at home helped children move their arms and legs better. Another study showed that exercises using videos improved neck control. Overall, home-based therapy, the focus of this trial, appears to be a promising way to boost physical abilities in children with cerebral palsy. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

Issues with the nerves that control movement.

You were born with a difference in your upper limb.

I have not participated in CIMT in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Home-based Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33028544/

Feasibility and effectiveness of home-based therapy ... To assess the feasibility and effectiveness of home-based occupational therapy and physiotherapy programmes in children with cerebral palsy (CP)

2. research.aota.org research.aota.org/ajot/article/79/4/7904205150/27207/Effectiveness-of-Intensive-and-Distributed

Effectiveness of Intensive and Distributed Bilateral Intensive ... Importance: Bilateral intensive training (BIT) has promising effects for children with unilateral cerebral palsy (UCP), ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425001346

The THRIVE-CP Trial - Targeted Home-Based Training ... The primary outcome is the percentage change in real-world daytime movement of the targeted extremity (right or left arm or leg). We hypothesize ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/10/10/e035454

Feasibility and effectiveness of home-based therapy ... 7 They concluded that home-based programmes using goal-directed training are effective in improving motor and functional outcomes.7 Another review by Sakzewski ...

5. bfpt.springeropen.com bfpt.springeropen.com/articles/10.1186/s43161-025-00289-9

Development, effectiveness, and usability of a home-based ... This study concluded that the video-based exercise tool had good usability among caregivers of children with CP and effectively improved neck control among ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10986357/

Safety, tolerability and feasibility of remotely-instructed ... Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy.

7. journals.sagepub.com journals.sagepub.com/doi/10.3233/PRM-220135

Effectiveness of simple and basic home-based exercise ... This study aimed to assess the effectiveness of simple and basic home-based exercise programs (HEPs), including pediatric massage (PM), executed by caregivers ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12100667/

Long-term outcome safety assessment after ... Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy.

9. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000850

Feasibility of HABIT-ILE@home in children with cerebral palsy ... This pilot study investigates if HABIT-ILE@home, a remote neurorehabilitation, is feasible for children with CP and adults with CS.