Cerebral PalsyAPPLES-TELENCT04997109
Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
A study testing APPLES-tele and Parent-centered Approach (PCA) Support Intervention in people with Cerebral Palsy, run by Emory University at 4 sites in United States.
Trial summary
This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 13 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- APPLES-tele and Parent-centered Approach (PCA) Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Feb 2022to 12 Oct 2026
- 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 4 to 13 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 4 to 13 months, corrected age
- Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)
- Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
- Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands >1
- Parent/legal guardian is able to provide informed consent
Who cannot join
- Congenital malformation of the brain or musculoskeletal system (MSK)
- Receipt of botulinum toxin to the affected extremity within 3 months of study entry
- Any prior long-term hard constraint programs
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
The University of Utah
Salt Lake City, Utah, 84112
About this study
This study assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is a disorder characterized by impairments of sensorimotor function resulting from neural insults in the perinatal period. Every year almost 10,000 children are born with CP in the US. CP incidence ranges from 2 to 3 per 1000 in North America, Australia, and Europe and is difficult to estimate in the developing world. Intervention strategies to promote function of children with CP must be adaptable to settings where resources or access may be limited, yet simultaneously integrate best clinical evidence and neuroscientific principles. Upper extremity (UE) impairments are present in a significant portion of children with CP, some with hemiplegia (~25% children with CP), and others with quadriplegia, in which one arm and hand may be more affected than the other (another ~25%). UE impairments in CP result from a combination of motor and sensory dysfunctions including a lack of high-quality motor experience, which combined with "noisy" (often faulty) sensory input, challenges the acquisition of new effective motor patterns.
Among the various approaches to improve UE function in infants with CP are constraint-induced movement therapy (the use of constraints on less affected limbs) and bimanual therapy (training of both extremities in coordination). Brief sessions of parent-delivered, infant-initiated, goal-directed, success-motivated and repetitive activity in enriched sensory environments can be effective, while respecting fundamental principles of infant development and home life. Parent administration of the intervention helps preserve the integrity of early parent-child relationships, critical to establishment of infants' sense of self, safety, and independence.
Finally, to take full advantage of neuroplasticity and maximize potential downstream developmental effects, it is essential to intervene as early as possible in children with CP. Promising new treatments such as transcranial magnetic stimulation, robotic-assisted movements and technology enhancements to movement feedback are in development. However, these interventions require substantial investments of highly-skilled therapists, technology, infrastructure and access to academic facilities. While the new interventions advance the cutting-edge of motor intervention development, on another leading edge, parent-delivered therapist-directed telehealth interventions are becoming more widespread, addressing a critical need for lower-resource interventions.
Healthcare systems resources are limited, and can be difficult to access due to geographic and socioeconomic obstacles. While telehealth therapy seems eminently practical, and a natural extension of current interventions for infants with CP, it faces its own scientific challenges. The same essential attributes of physical therapy that make it so effective in person can make it difficult to deliver via telehealth. Telehealth therapy in infants requires a level of parent engagement, knowledge and parenting skills that is sometimes lacking. Feasible telehealth interventions to improve function in infants with CP must also address the challenges faced by their parents in conducting the sessions through effective parenting supports.
In this study, infant participants with CP will be randomized to one of three treatment groups:
- The APPLES intervention via telehealth (APPLES-tele) followed by a parent-centered approach (PCA) intervention
- The PCA intervention followed by the APPLES-tele intervention
- The standard of care
Outcome measures will be standardized assessments of hand/arm function and validated parent-report measures of infant motor activity.
- Conditions
- Cerebral Palsy
- Being tested
- APPLES-tele, Parent-centered Approach (PCA) Support Intervention, Standard of Care
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPLES-teleOther
Also called C-Mitt
The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty.
Parent-centered Approach (PCA) Support InterventionBehavioural
The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.
Standard of CareBehavioural
Participants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network.
| Study group | Role | What they receive |
|---|---|---|
| APPLES-tele first, then PCA | Experimental | Participants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks. Receives: Other: APPLES-tele; Behavioral: Parent-centered Approach (PCA) Support Intervention |
| PCA first, then APPLES-tele | Experimental | Participants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks. Receives: Other: APPLES-tele; Behavioral: Parent-centered Approach (PCA) Support Intervention |
| Standard of Care Control Arm | Active comparator | Participants receiving the standard of care for 6 weeks. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score
The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function of the more affected upper extremity is assessed using the 54 unimanual items of the Bayley-3 instrument. Responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total unimanual fine motor raw scores for the more affected arm range from 0 to 108 where higher scores indicate greater fine motor function.
Measured: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score
The Authoritative Parenting Style scale of the Parenting Styles and Dimensions Questionnaire (PSDQ) - short version, includes 15 items that are rated on a 5-point scale where 1 = never and 5 = always. The raw score ranges from 15 to 75 and higher scores indicate a more expression of the authoritative parenting style.
Measured: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Secondary outcomes (5)
Infant Motor Activity Log (IMAL) How Often Score
Parent perception of hand performance is assessed with the IMAL. The IMAL includes 20 items asking caregivers how often and how well the infant uses their less preferred hand. Responses are given on a 5-point Likert scale where 0 = not used and 5 = normal use. Raw scores on how often the infant uses their less preferred hand range from 0 to 100, with higher scores indicating more normal hand usage.
Measured: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Hand Assessment in Infants (HAI) Score
The HAI is an assessment evaluating quality and frequency of hand abilities in infants 3 to 12 months corrected age using a semi-structured 12-15 min videotaped play session that is scored by a certified therapist. There are 12 unimanual and 5 bimanual items, each is scored on a 3-point rating scale, of 0, 1, or 2 points. Each hand receives a raw score based upon performance on the unimanual items. The raw score for the more affected hand will be reported as a continuous variable. Total raw scores for the unimanual items range from 0 to 24 and higher scores indicate greater ability.
Measured: Baseline, Week 6 (after the first intervention)
Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score
The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function scale of the Bayley-3 instrument includes 66 items, and responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total fine motor raw scores range from 0 to 132 where higher scores indicate greater fine motor function.
Measured: Baseline, Week 6 (after the first intervention)
Welch Emotional Connection Screen (WECS) Score
The WECS assesses parent-infant connection by examining four emotional connection dimensions of behavior: attraction, vocal communication, facial communication, and sensitivity. Items are rated on a 3-point scale where 1 = low and 3 = high. A WECS Mother (WECS-M) score is created by summing the four items for maternal connection while the four items for infant connection create a WECS Infant (WECS-I) score. Total WECS-M or WECS-I scores range from 4 to 12 where higher scores indicate greater connection.
Measured: Baseline, Week 6 (after the first intervention)
Maternal Confidence Questionnaire (MCQ) Score
The MCQ assesses parent knowledge and confidence in caring for and understanding their infant. The MCQ has 14 items which are scored on a 5-point scale where 1 = never and 5 = a great deal. Scores are reversed for some items and total scores range from 14 to 70. Higher scores indicate greater maternal confidence.
Measured: Baseline, Week 6 (after the first intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start23 Feb 2022
- Primary completion12 Oct 2026
- Study completion12 Oct 2026
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 Emory UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two active treatments will be administered in different sequences, and will be compared with a standard of care study arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nathalie Maitre, Emory University
- Investigators
- Nathalie Maitre, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997109
- Sponsor's protocol ID
- STUDY00003197
- Other IDs
- 2R01HD081120, 2025P011605
- Acronym
- APPLES-TELE
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in Early Childhood Constraint Therapy in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04997109
- Acronym / sponsor ID
- APPLES-TELE / STUDY00003197
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 12 Oct 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 9 Aug 2021 (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 assesses two active treatments in different sequences and a standard of care group among infants with cerebral palsy.
Detailed description
Cerebral palsy (CP) is a disorder characterized by impairments of sensorimotor function resulting from neural insults in the perinatal period. Every year almost 10,000 children are born with CP in the US. CP incidence ranges from 2 to 3 per 1000 in North America, Australia, and Europe and is difficult to estimate in the developing world. Intervention strategies to promote function of children with CP must be adaptable to settings where resources or access may be limited, yet simultaneously integrate best clinical evidence and neuroscientific principles. Upper extremity (UE) impairments are present in a significant portion of children with CP, some with hemiplegia (~25% children with CP), and others with quadriplegia, in which one arm and hand may be more affected than the other (another ~25%). UE impairments in CP result from a combination of motor and sensory dysfunctions including a lack of high-quality motor experience, which combined with "noisy" (often faulty) sensory input, challenges the acquisition of new effective motor patterns.
Among the various approaches to improve UE function in infants with CP are constraint-induced movement therapy (the use of constraints on less affected limbs) and bimanual therapy (training of both extremities in coordination). Brief sessions of parent-delivered, infant-initiated, goal-directed, success-motivated and repetitive activity in enriched sensory environments can be effective, while respecting fundamental principles of infant development and home life. Parent administration of the intervention helps preserve the integrity of early parent-child relationships, critical to establishment of infants' sense of self, safety, and independence.
Finally, to take full advantage of neuroplasticity and maximize potential downstream developmental effects, it is essential to intervene as early as possible in children with CP. Promising new treatments such as transcranial magnetic stimulation, robotic-assisted movements and technology enhancements to movement feedback are in development. However, these interventions require substantial investments of highly-skilled therapists, technology, infrastructure and access to academic facilities. While the new interventions advance the cutting-edge of motor intervention development, on another leading edge, parent-delivered therapist-directed telehealth interventions are becoming more widespread, addressing a critical need for lower-resource interventions.
Healthcare systems resources are limited, and can be difficult to access due to geographic and socioeconomic obstacles. While telehealth therapy seems eminently practical, and a natural extension of current interventions for infants with CP, it faces its own scientific challenges. The same essential attributes of physical therapy that make it so effective in person can make it difficult to deliver via telehealth. Telehealth therapy in infants requires a level of parent engagement, knowledge and parenting skills that is sometimes lacking. Feasible telehealth interventions to improve function in infants with CP must also address the challenges faced by their parents in conducting the sessions through effective parenting supports.
In this study, infant participants with CP will be randomized to one of three treatment groups:
- The APPLES intervention via telehealth (APPLES-tele) followed by a parent-centered approach (PCA) intervention
- The PCA intervention followed by the APPLES-tele intervention
- The standard of care
Outcome measures will be standardized assessments of hand/arm function and validated parent-report measures of infant motor activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Two active treatments will be administered in different sequences, and will be compared with a standard of care study arm.
| Arm | Type | Receives |
|---|---|---|
| APPLES-tele first, then PCA | Experimental | Other: APPLES-tele, Behavioral: Parent-centered Approach (PCA) Support InterventionParticipants receiving the APPLES-tele intervention for 6 weeks followed by the PCA intervention for 6 weeks. |
| PCA first, then APPLES-tele | Experimental | Other: APPLES-tele, Behavioral: Parent-centered Approach (PCA) Support InterventionParticipants receiving the PCA intervention for 6 weeks followed by the APPLES-tele intervention for 6 weeks. |
| Standard of Care Control Arm | Active comparator | Behavioral: Standard of CareParticipants receiving the standard of care for 6 weeks. |
Who may qualify
- Ages
- 4 to 13 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 4 to 13 months, corrected age
- Diagnosis of CP or classification of high-risk for CP as determined by published guidelines (>95% risk of later CP)
- Hammersmith Infant Neurological Exam (HINE) arm asymmetry score of greater than or equal to 2 and/or neuroimaging consistent with perinatal involvement
- Hand Assessment for Infants (HAI) difference between hands ≥2, with an observable and relative difference in quality or amount of movement between hands, as determined by HAI-certified study therapists and/or a unimanual Bayley score difference between hands >1
- Parent/legal guardian is able to provide informed consent
Key exclusion criteria (3 listed)
- Congenital malformation of the brain or musculoskeletal system (MSK)
- Receipt of botulinum toxin to the affected extremity within 3 months of study entry
- Any prior long-term hard constraint programs
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 |
|---|---|---|
| APPLES-teleAlso: C-MittThe APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to complete play-based activities as instructed by the study therapist. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty. | Other | APPLES-tele first, then PCA, PCA first, then APPLES-tele |
| Parent-centered Approach (PCA) Support InterventionThe PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP. | Behavioural | APPLES-tele first, then PCA, PCA first, then APPLES-tele |
| Standard of CareParticipants will receive the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network. | Behavioural | Standard of Care Control Arm |
Primary outcome
Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score
Time frame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
The Bayley-3 instrument is a norm-referenced test assessing developmental delays in early childhood. The fine motor function of the more affected upper extremity is assessed using the 54 unimanual items of the Bayley-3 instrument. Responses are provided on a 3-point scale where 0 = the skill is not present, 1 = the skill is emerging, and 2 = the skill is mastered. Total unimanual fine motor raw scores for the more affected arm range from 0 to 108 where higher scores indicate greater fine motor function.
Parenting Styles and Dimensions Questionnaire (PSDQ) Authoritative Scale Score
Time frame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
The Authoritative Parenting Style scale of the Parenting Styles and Dimensions Questionnaire (PSDQ) - short version, includes 15 items that are rated on a 5-point scale where 1 = never and 5 = always. The raw score ranges from 15 to 75 and higher scores indicate a more expression of the authoritative parenting style.
5 secondary outcomes
Infant Motor Activity Log (IMAL) How Often Score
Time frame: Baseline, Week 6 (after the first intervention), Week 12 (after the second intervention)
Hand Assessment in Infants (HAI) Score
Time frame: Baseline, Week 6 (after the first intervention)
Bayley Scales of Infant and Toddler Development (Bayley-3) Global Fine Motor Function Score
Time frame: Baseline, Week 6 (after the first intervention)
Welch Emotional Connection Screen (WECS) Score
Time frame: Baseline, Week 6 (after the first intervention)
Maternal Confidence Questionnaire (MCQ) Score
Time frame: Baseline, Week 6 (after the first 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 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Nathalie Maitre, MD, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APPLES-tele and Parent-centered Approach (PCA) Support Intervention in people with Cerebral Palsy, run by Emory University at 4 sites 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 3 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Bayley Scales of Infant and Toddler Development (Bayley-3) More Affected Arm Motor Function Score (time frame: Baseline, Week 6 (after the first intervention), Week 12 (after the second 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 4 Nov 2026.