Cerebral PalsyNCT06040619
Implementation of Therapy Together
A study testing Therapy Together in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. Read more about this study
- Who is it for?
- Ages 3 to 71 months
- Conditions the study is for
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- Therapy Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
- children ages 3 months to 5 years 11 months
- present with asymmetric hand use
- present with a unilateral upper limb impairment
- able to visually attend to objects
- demonstrate an interest in objects
- attempt to reach for or grasp objects with the impaired upper extremity
Who cannot join
- uncontrolled epilepsy
- significant visual impairment
- severe behavioral problems
- inability to complete the assessment protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Scottish Rite for Children
Frisco, Texas, 75034
Angela Shierk, PhD, 469-412-7172, angela.shierk@tsrh.org
About this study
Official title: Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question[s] it aims to answer are:
- Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care?
- Is it feasible to implement the Therapy Together program within the standard care, early intervention framework?
Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.
Read the detailed description
A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.
Therapy Together Program:
The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 sessions with their therapist. The therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- Therapy Together, Usual Care
- Keywords
- constraint induced movement therapy, caregiver coaching
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy TogetherBehavioural
8-week caregiver-led pediatric constraint-induced movement therapy program
Usual CareBehavioural
8 weeks of usual care received in an early intervention therapy program
| Study group | Role | What they receive |
|---|---|---|
| Therapy Together | Experimental | Participants will complete the 8-week Therapy Together program. Receives: Behavioral: Therapy Together |
| Usual Care | Active comparator | Participants will complete 8 weeks of usual care in early intervention. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Assisting Hand Assessment
The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
Measured: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Assisting Hand Assessment
The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
Measured: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Hand Assessment for Infants
The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)
Measured: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Secondary outcomes (3)
Canadian Occupational Performance Measure
The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)
Measured: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Developmental Assessment for Young Children, Second Edition (DAYC-2)
The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)
Measured: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Measure of Hand and Arm Performance
The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10
Measured: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start13 Nov 2023
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
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.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot randomized control trial comparing treatment group to usual care. The usual care group will have the option to cross over to the treatment group after 8 weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Angela Shierk, Texas Scottish Rite Hospital for Children
- Investigators
- Angela Shierk, PhD, Principal investigator, Scottish Rite for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040619
- Sponsor's protocol ID
- STU-2023-0553
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2023
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
- ClinicalTrials.gov ID
- NCT06040619
- Acronym / sponsor ID
- STU-2023-0553
- Conditions
- Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- constraint induced movement therapy, caregiver coaching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Sep 2023 (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 goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question[s] it aims to answer are:
- Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care?
- Is it feasible to implement the Therapy Together program within the standard care, early intervention framework?
Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.
Detailed description
A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.
Therapy Together Program:
The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 sessions with their therapist. The therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized control trial comparing treatment group to usual care. The usual care group will have the option to cross over to the treatment group after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Therapy Together | Experimental | Behavioral: Therapy TogetherParticipants will complete the 8-week Therapy Together program. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will complete 8 weeks of usual care in early intervention. |
Who may qualify
- Ages
- 3 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
- children ages 3 months to 5 years 11 months
- present with asymmetric hand use
- present with a unilateral upper limb impairment
- able to visually attend to objects
Key exclusion criteria (4 listed)
- uncontrolled epilepsy
- significant visual impairment
- severe behavioral problems
- inability to complete the assessment protocol.
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 |
|---|---|---|
| Therapy Together8-week caregiver-led pediatric constraint-induced movement therapy program | Behavioural | Therapy Together |
| Usual Care8 weeks of usual care received in an early intervention therapy program | Behavioural | Usual Care |
Primary outcome
Mini-Assisting Hand Assessment
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
Assisting Hand Assessment
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
Hand Assessment for Infants
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)
3 secondary outcomes
Canadian Occupational Performance Measure
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Developmental Assessment for Young Children, Second Edition (DAYC-2)
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Measure of Hand and Arm Performance
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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.
Angela Shierk, PhD principal investigator
Scottish Rite for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Together in people with Cerebral Palsy and Hemiplegic Cerebral Palsy, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Shierk, PhD ((469) 412-7172 ext. 1045, angela.shierk@tsrh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Assisting Hand Assessment (time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-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 6 Oct 2026.