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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

South Korea1 site
  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

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 groups in NCT06272760
Study groupRoleWhat they receive
Tele-HABITExperimentalChildren 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)
ControlNo interventionChildren 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  1. First posted22 Feb 2024
  2. Study start1 Dec 2024
  3. Primary completion20 Feb 2026
  4. Study completion28 Feb 2026

Resources

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)
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

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.

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Clinical Trial NCT06272760 | AzTrials