Cerebral PalsyHEIGHTENNCT05346887
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
A study testing Home-based Therapy in people with Cerebral Palsy and Perinatal Stroke, run by University of Calgary at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Cerebral Palsy, Perinatal Stroke
- What is being tested?
- Home-based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 1 May 2022to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta
University of Alberta
Edmonton, Alberta
About this study
The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.
- Conditions
- Cerebral Palsy, Perinatal Stroke
- Being tested
- Home-based Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Therapy | Experimental | Not described Receives: Behavioral: Home-based Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: <7 days after the 18-week intervention
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.
Measured: <7 days after the 18-week intervention
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.
Measured: <7 days after the 18-week intervention
Secondary outcomes (2)
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.
Measured: 8 weeks +/-3days after the the 18-week intervention.
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.
Measured: 8 weeks +/-3days after the the 18-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346887
- Sponsor's protocol ID
- 21-1981
- Acronym
- HEIGHTEN
- Status last verified
- Dec 2024
- First submitted
- 28 Mar 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture
- ClinicalTrials.gov ID
- NCT05346887
- Acronym / sponsor ID
- HEIGHTEN / 21-1981
- Conditions
- Cerebral Palsy, Perinatal Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based Therapy | Experimental | Behavioral: Home-based Therapy |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based TherapyThe 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. | Behavioural | Home-based Therapy |
Primary outcome
Satisfaction of therapists
Time frame: <7 days after the 18-week intervention
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)
Time frame: <7 days after the 18-week intervention
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)
Time frame: <7 days after the 18-week intervention
The HAI/mini-AHA/AHA employ a video-recorded play-based session of <15 minutes to provide a logit-based measure of manual function.
2 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: 8 weeks +/-3days after the the 18-week intervention.
Age-appropriate hand assessment (HAI/mini-AHA/AHA)
Time frame: 8 weeks +/-3days after the the 18-week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Therapy in people with Cerebral Palsy and Perinatal Stroke, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of therapists (time frame: <7 days after the 18-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.