Cerebral PalsyNCT06272760
Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy
A study testing Home-based hand-arm bimanual intensive training (Tele-HABIT) in people with Cerebral Palsy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Home-based hand-arm bimanual intensive training (Tele-HABIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2024to 28 Feb 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 12 years
- MACS level 1-4
- Diagnosed with CP due to central nervous system lesions
Who cannot join
- Individuals with a Manual Ability Classification System (MACS) level V, indicating an inability to use both hands in daily life activities.
- Individuals who fall within levels 0 to 4 of the House Functional Classification System.
- Individuals with severe intellectual disabilities, characterized by difficulties in understanding or following instructions.
- Individuals with vision impairment that could affect participation in the therapy.
- Individuals who have received a botulinum toxin injection in the upper extremity within the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Remote Therapy Protocol Using Multimodal Sensor Fusion for Upper Limb Function Enhancement in Children With Cerebral Palsy
The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy.
Read the detailed description
- Development of a home-based remote upper limb function evaluation program using heterogeneous (multimodal) sensors.
- Development of a home-based remote upper limb function improvement treatment program using heterogeneous sensors.
- Conditions
- Cerebral Palsy
- Being tested
- Home-based hand-arm bimanual intensive training (Tele-HABIT)
- Keywords
- Cerebral palsy, Physical activity, Telerehabilitation, Accelerometer
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based hand-arm bimanual intensive training (Tele-HABIT)Other
Hand-Arm Bimanual Intensive Therapy (HABIT) is a therapeutic approach designed to improve the motor skills and functional use of both arms in individuals with conditions such as cerebral palsy. The core principle of HABIT is to encourage voluntary exercise by actively engaging the affected side, which may be weaker or partially paralyzed, in various activities. This approach aims to reduce physical and mental discomfort while maximizing the effectiveness of the training. HABIT has been adapted into a home-based format by ZOOM, referred to as Home-Based HABIT (H-HABIT).
| Study group | Role | What they receive |
|---|---|---|
| Tele-HABIT | Experimental | Children in the experimental group are going to receive intensive bimanual activity-based occupational therapy, known as Home-Based HABIT (H-HABIT). This therapy is going to be administered remotely. Each session will last for 2 hours and was conducted 5 times a week. The total duration of this intervention is 3 weeks. Receives: Other: Home-based hand-arm bimanual intensive training (Tele-HABIT) |
| Control | No intervention | Children in the control group will not receive any intervention during the 3-week study period. They will be placed on a waitlist and offered the same therapy after the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0).
AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.
Measured: Baseline and 1 month (post intervention)
Secondary outcomes (7)
Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0).
The PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).
Measured: Baseline and 1 month (post intervention)
Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0).
The Melbourne Assessment 2 (MA2) is a specific upper limb assessment focusing on the capacity of one hand. It benchmarks against certain criteria, delving into facets like movement range, accuracy, agility, and flow. The test was videotaped for analysis, and the raw score converted to a percentage of the maximal score.The higher the score, the better the motor function is interpreted. Test-retest results revealed moderate to high intrarater reliability for item totals (mean of 0.83 and 0.79) for each rater and high reliability for test totals (0.98 and 0.97).
Measured: Baseline and 1 month (post intervention)
Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0).
The COPM was designed as an outcome measure with a semi-structured interview format and structured scoring method to assess a person's level of self-efficacy. It conceptualizes self-efficacy in terms of self-perception of performance and satisfaction with performance. The COPM uses three 10-point rating scales to rate importance, performance and satisfaction. A score value of '1' refers to a low rating (i.e. 'not important at all', not able to do it at all', 'not satisfied at all'). A score value of '10' refers to a high rating (i.e. 'extremely important', 'able to do it extremely well', 'extremely satisfied'). Summing the ratings across problems and dividing by the total number of problems derive separate total performance and satisfaction scores.
Measured: Baseline and 1 month (post intervention)
Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0).
The Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) was developed to respond to the need for an accurate and efficient functional measure with content for children and youth in multiple functional content areas. The new PEDI-CAT measures function in the three domains of Daily Activities, Mobility and Social/Cognitive for infants, children and youth from birth through 20 years of age. In addition, the PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks. The higher the score, the better the functional ability is interpreted.
Measured: Baseline and 1 month (post intervention)
Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0).
The magnitude ratio is calculated as a metric to compare the magnitude of acceleration of the arms at each time point: ln(paretic magnitude/nonparetic magnitude). The magnitude will be calculated by taking the vector magnitude of the activity counts for each epoch. The natural log will be used to avoid skewness in the ratio caused by an underestimation of the denominator. The average magnitude will be calculated for each period. A magnitude ratio near 0 indicates similar use of each arm, a negative number indicates more use of the nonparetic arm, and a positive number indicates more use of the paretic arm.
Measured: Baseline and 1 month (post intervention)
Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0).
The bilateral magnitude is used to compare the overall movement of both arms together as a measure of bilateral arm movement: nonparetic magnitude + paretic magnitude. As with the magnitude ratio, the vector magnitude of the activity counts will be calculated for each epoch. A greater bilateral magnitude indicates greater overall movement of both arms.
Measured: Baseline and 1 month (post intervention)
Quantitative Analysis of Ocular Motor Function Using a Wearable Eye-Tracking Device (Neon)
This outcome assesses ocular motor function through the use of a wearable eye-tracking device (Neon; Pupil Labs GmbH, Germany). The Neon system records real-time eye movement parameters during standardized visual-perceptual and motor tasks without requiring calibration. Key variables include fixation duration, saccadic amplitude, pupil dilation, and gaze stability. Data will be used to identify oculomotor biomarkers that reflect potential deficits in visual-motor integration and central visual-vestibular processing in children with unilateral cerebral palsy. Eye-tracking recordings are synchronized with task performance and analyzed using validated software (Pupil Cloud). This objective measure is intended to complement clinical test scores and provide deeper insight into underlying sensorimotor integration difficulties.
Measured: Baseline and 1 month (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Dec 2024
- Primary completion20 Feb 2026
- Study completion28 Feb 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 Samsung Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
- Investigators
- JEONG-YI KWON, MD, PHD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272760
- Sponsor's protocol ID
- 2024-02-060
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Remote Therapy Protocol Using Multimodal Sensor Fusion for Upper Limb Function Enhancement in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06272760
- Acronym / sponsor ID
- 2024-02-060
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Physical activity, Telerehabilitation, Accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 22 Feb 2024 (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 perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy.
Detailed description
- Development of a home-based remote upper limb function evaluation program using heterogeneous (multimodal) sensors.
- Development of a home-based remote upper limb function improvement treatment program using heterogeneous sensors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Tele-HABIT | Experimental | Other: Home-based hand-arm bimanual intensive training (Tele-HABIT)Children in the experimental group are going to receive intensive bimanual activity-based occupational therapy, known as Home-Based HABIT (H-HABIT). This therapy is going to be administered remotely. Each session will last for 2 hours and was conducted 5 times a week. The total duration of this intervention is 3 weeks. |
| Control | No intervention | –Children in the control group will not receive any intervention during the 3-week study period. They will be placed on a waitlist and offered the same therapy after the study is completed. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6 to 12 years
- MACS level 1-4
- Diagnosed with CP due to central nervous system lesions
Key exclusion criteria (5 listed)
- Individuals with a Manual Ability Classification System (MACS) level V, indicating an inability to use both hands in daily life activities.
- Individuals who fall within levels 0 to 4 of the House Functional Classification System.
- Individuals with severe intellectual disabilities, characterized by difficulties in understanding or following instructions.
- Individuals with vision impairment that could affect participation in the therapy.
- Individuals who have received a botulinum toxin injection in the upper extremity within the past 6 months.
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 hand-arm bimanual intensive training (Tele-HABIT)Hand-Arm Bimanual Intensive Therapy (HABIT) is a therapeutic approach designed to improve the motor skills and functional use of both arms in individuals with conditions such as cerebral palsy. The core principle of HABIT is to encourage voluntary exercise by actively engaging the affected side, which may be weaker or partially paralyzed, in various activities. This approach aims to reduce physical and mental discomfort while maximizing the effectiveness of the training. HABIT has been adapted into a home-based format by ZOOM, referred to as Home-Based HABIT (H-HABIT). | Other | Tele-HABIT |
Primary outcome
Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.
7 secondary outcomes
Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0).
Time frame: Baseline and 1 month (post intervention)
Quantitative Analysis of Ocular Motor Function Using a Wearable Eye-Tracking Device (Neon)
Time frame: Baseline and 1 month (post 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 10 Mar 2026.
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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.
JEONG-YI KWON, MD, PHD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based hand-arm bimanual intensive training (Tele-HABIT) in people with Cerebral Palsy, run by Samsung Medical Center at 1 site in South Korea.
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 3 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 10 Mar 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 South Korea. 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?
Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0). (time frame: Baseline and 1 month (post intervention)). 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 Mar 2026.