Cerebral PalsyNCT07225673
Feasibility and Effectiveness of Therapy Together
A study testing Therapy Together - 4 hour group and Therapy Together - 1 hour group in people with Cerebral Palsy, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial summary
this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months. Read more about this study
- Who is it for?
- Ages 3 to 59 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Therapy Together - 4 hour group and Therapy Together - 1 hour group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 30 Sep 2026
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- present with asymmetric hand
- at risk for developing CP or children that have been diagnosed with CP
- must be able to visually attend to objects
- demonstrate an interest in objects
- attempt to reach for or grasp them 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.
About this study
Official title: Feasibility and Effectiveness of Therapy Together: An Intensive Upper Limb Therapy Program for Young Children With Cerebral Palsy and Their Caregivers
this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months.
Read the detailed description
One group will complete 32 hours onsite (4 hour weekly sessions) and 30 minutes of therapeutic activity at home, and the second group will complete 8 hours onsite and 1 hour of therapeutic activity at home. Both groups will aim to complete 56 hours of the intervention.
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 coaching sessions. 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
- Being tested
- Therapy Together - 4 hour group, Therapy Together - 1 hour group
- 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 Together - 4 hour groupBehavioural
a caregiver partnered constraint induced movement therapy program
Therapy Together - 1 hour groupBehavioural
a caregiver partnered constraint induced movement therapy program
| Study group | Role | What they receive |
|---|---|---|
| 4 hour group | Active comparator | The 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program. Receives: Behavioral: Therapy Together - 4 hour group |
| 1 hour group | Active comparator | The 1-hour group completed 8 hours of in-clinic therapy and 48 hours of home-based activities (1 hour per day) to complete the Therapy Together program. Receives: Behavioral: Therapy Together - 1 hour group |
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: 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: 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: 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: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Weekly Caregiver Log
The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
Measured: weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start2 Jan 2020
- Primary completion20 Jul 2024
- Study completion30 Sep 2026 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Shierk, Principal investigator, Scottish Rite for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225673
- Sponsor's protocol ID
- STU-2019-1211
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2025
- Last updated
- 10 Nov 2025
- 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 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Therapy Together: An Intensive Upper Limb Therapy Program for Young Children With Cerebral Palsy and Their Caregivers
- ClinicalTrials.gov ID
- NCT07225673
- Acronym / sponsor ID
- STU-2019-1211
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Nov 2025 (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.
this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months.
Detailed description
One group will complete 32 hours onsite (4 hour weekly sessions) and 30 minutes of therapeutic activity at home, and the second group will complete 8 hours onsite and 1 hour of therapeutic activity at home. Both groups will aim to complete 56 hours of the intervention.
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 coaching sessions. 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 hour group | Active comparator | Behavioral: Therapy Together - 4 hour groupThe 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program. |
| 1 hour group | Active comparator | Behavioral: Therapy Together - 1 hour groupThe 1-hour group completed 8 hours of in-clinic therapy and 48 hours of home-based activities (1 hour per day) to complete the Therapy Together program. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- present with asymmetric hand
- at risk for developing CP or children that have been diagnosed with CP
- must be able to visually attend to objects
- demonstrate an interest in objects
- attempt to reach for or grasp them with the impaired upper extremity
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 Together - 4 hour groupa caregiver partnered constraint induced movement therapy program | Behavioural | 4 hour group |
| Therapy Together - 1 hour groupa caregiver partnered constraint induced movement therapy program | Behavioural | 1 hour group |
Primary outcome
Mini-Assisting Hand Assessment
Time frame: 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: 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)
3 secondary outcomes
Canadian Occupational Performance Measure
Time frame: 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: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Weekly Caregiver Log
Time frame: weekly for 8 weeks
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 10 Nov 2025.
- 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.
Angela Shierk 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 - 4 hour group and Therapy Together - 1 hour group in people with 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 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. 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?
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?
Mini-Assisting Hand Assessment (time frame: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]). The study lists 2 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 10 Nov 2025.