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Cerebral PalsyFuN HABIT-ILENCT06428032

Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in people with Cerebral Palsy, run by Universidad Nacional Andres Bello at 1 site in Chile.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChile
Study dates
3 Jun 2024to 31 Dec 2027
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 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children with medical diagnosis of bilateral cerebral palsy
  • Cognitive capacity and language that allows understanding and following the therapist's instructions.
  • Manual Ability Classification System (MACS) levels I to III
  • Bimanual Fine Motor Function (BFMF) levels I to III
  • Gross Motor Function Classification System (GMFCS) levels I to III

Who cannot join

  • Severe visual problems
  • Movement restriction due to orthopedic surgery in less than a year
  • Treatment with botulinum toxin and/or baclofen pump in the last 6 months
  • Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chile1 site, 1 recruiting
  • Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello

    Santiago, Santiago Metropolitan, 7591538

    Rodrigo Araneda, PhD

    Recruiting

Other trials in Chile

About this study

Official title: Functional and Neuroplastic Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy: a Randomized Controlled Trial

This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.

Read the detailed description

This study aims to compare, for the first time, the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period, in people with bilateral cerebral palsy (CP). Previous HABIT-ILE protocols have only assessed the effects of a single intervention period. Still, the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function.

A randomized controlled trial will be conducted, comparing the effects of a double period of HABIT-ILE; (2HG; n=24) versus a single period (1HG; n=24) in children and youth with bilateral CP. Each HABIT-ILE period will consider 6.5 hours of intervention during 10 consecutive working days. Children will be assessed at 6-time points: baseline, three weeks after, at 3 months, at 6 months, at 7 months, and at 9 months, to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables. The 1HG will receive only 65 hours of HABIT-ILE after baseline; the 2HG will perform 130 hours over two intervention periods, after baseline and again at 6 months.

Overall, this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP. It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE.

Conditions
Cerebral Palsy
Being tested
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Keywords
HABIT-ILE, Intensive motor therapy, Motor skill learning, Children
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hand-Arm Bimanual Intensive Therapy Including Lower ExtremitiesBehavioural

    Also called HABIT-ILE

    Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

  • Hand-Arm Bimanual Intensive Therapy Including Lower ExtremitiesBehavioural

    Also called HABIT-ILE

    Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.

Study groups in NCT06428032
Study groupRoleWhat they receive
Double periodExperimentalSubjects will receive 130 hours of HABIT-ILE performed in two intervention periods as camp format for 6,5-hours/day, 5 days/week for two weeks. Each intervention period will be 6-months apart.
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Single periodExperimentalSubjects will receive 65 hours of HABIT-ILE performed in one intervention period as camp format for 6,5-hours/day, 5 days/week for two weeks
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Gross Motor Function

    The Gross Motor Function Measure is a standardized observational instrument designed to measure changes in gross motor function over time or following an intervention in children and youth with cerebral palsy using Rasch analysis. It is scored on a scale of 0 to 3, where 0 means the person cannot perform the activity and 3 means the person can complete the item. The score is converted to a percentage. A higher percentage means a better gross motor function.

    Measured: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

Secondary outcomes (17)
  1. Both Hands Assessment (BoHA)

    The Both Hands Assessment is a valid test for children with mild to moderate bilateral manual abilities impairments. It can evaluate bimanual activity performance and the level of upper extremity asymmetry. It rates performance between 1 (does not do) and 4 (effective). The final score is converted to BoHA units (logit 0 - 100), where higher scores reflect better bimanual use.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]

  2. Melbourne 2 Assessment (MA2)

    The Melbourne 2 Assessment (MA2) assesses the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy, and range of movement during several tasks of reaching and manipulation. The result is obtained as a percentage of the function of each item. A higher percentage means a better unilateral performance of the upper extremity.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)]

  3. Test of Arm Selective Control (TASC)

    The TASC test assesses the selective voluntary motor control of upper limbs in individuals with cerebral palsy. The participant must execute eight movements in the upper extremity. The execution of each sequence will be assessed on a scale of 0, 1, or 2, from absence, impairment, or normality of voluntary selective motor control, respectively, with a maximum of 16 points per side and 32 points overall.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  4. Selective Control Assessment of the Lower Extremity (SCALE)

    The SCALE test assesses the selective voluntary motor control of lower limbs in individuals with cerebral palsy. The participant must execute five movements in the lower extremity. The execution of each sequence will be assessed on a scale of 0, 1 or 2, from absence, impairment, or normality of voluntary selective motor control respectively, with a maximum of 10 points per side and 20 points overall.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  5. Six minutes walk test (6MWT)

    The 6MWT measures the maximum distance a participant can walk in a 6-minute period in a 30-meter corridor at his or her own pace. More distance walked (in meters) indicates better performance.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  6. Attention network test (ANT)

    The ANT assesses the efficiency of the three attentional networks: alerting, orienting, and executive control networks. It measures the accuracy (in terms of the amount of errors) and the reaction time (milliseconds) of each network. Fewer errors mean more accuracy, the lower the score, the faster the reaction time.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  7. ABILHAND-Kids questionnaire

    This parent's filled questionnaire measures the ability of the participant with cerebral palsy to perform activities of daily living that require the use of the upper extremities. The difficulty to perform the activities are rating as "Impossible", "Difficult" or "Easy". The result is obtained in logits and can be interpreted as a percentage, where 0% indicates minimum ability and 100% maximum ability to perform the activities.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  8. ACTIVLIM-CP questionnaire

    This parent's filled questionnaire measures a child performance of daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance). The result is obtained in logits and can be interpreted as a percentage, where 0% indicates minimum ability and 100% maximum ability to perform the activities.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  9. Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)

    This parent's filled questionnaire measures the performance of the child in the daily life activities and movement domains, focusing on the capacity of upper extremities and lower extremities during these activities. It ranges from 20 to 80 (higher score means better performance).

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  10. Participation and Environment Measure - Children and Youth (PEM-CY)

    This parent's filled questionnaire measures participation of children and youth with or without disability, in the home, school and community, along with environmental factors within each of these settings. For each environment, it assesses how frequently they participate in a given activity (8-point scale; 0-7), how involved they are in that activity (5-point scale; 1-5), and whether they want to make a change in the type of participation they perform (6-point scale; 1-6). For each setting, the participation frequency (percentage), involvement (score 1-5), desires for change (percentage), and environmental supportiveness (percentage) are calculated.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  11. Canadian Occupational Performance Measure (COPM)

    This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10; higher score means better performance/satisfaction).

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)

  12. Behaviour Rating Inventory of Executive Function (BRIEF-2)

    The BRIEF-2 is a caregiver-reported questionnaire measuring executive functioning in children between 5 and 18 years old. It consists of 63 items arranged in nine scales: inhibition, self-monitoring, flexibility, emotional control, initiative, working memory, planning and organization, task supervision, and organization of materials. It is scored using T scores (Range= 34 - 90; Mean=50, Standard Deviation=10), where higher scores indicate greater problems with executive functioning.

    Measured: Time Frame: Baseline (T0), at 3 months (T2), at 6 months (T3), and at 9 months (T5)

  13. Changes of peak-to-peak amplitude of motor evoked potential

    A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of peak-to-peak amplitude of motor evoked potential will be measured in milliAmpere (mA).

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)

  14. Changes of Resting Motor Threshold

    A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of resting motor threshold will be measured in percentage.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)

  15. Changes of latency in motor evoked potential

    A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of latency in motor evoked potential will be measured in milliseconds.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)

  16. Changes of oxyhemoglobin concentration in sensorimotor cortex

    A functional near-infrared spectroscopy will be used to assess cortical activity. It is a noninvasive brain imaging tool that records optical density measurements to determine the change in oxyhemoglobin concentration (μM) in sensorimotor cortex area during manual tasks.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)

  17. Changes of oxyhemoglobin concentration in prefrontal cortex

    A functional near-infrared spectroscopy will be used to assess cortical activity. It is a noninvasive brain imaging tool that records optical density measurements to determine the change in oxyhemoglobin concentration (μM) in prefrontal cortex area during manual tasks.

    Measured: Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start3 Jun 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06428032
Sponsor's protocol ID
NEUROLAB_UNAB_001
Acronym
FuN HABIT-ILE
Status last verified
Jul 2024
First submitted
20 May 2024
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in people with Cerebral Palsy, run by Universidad Nacional Andres Bello at 1 site in Chile.

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: looking for participants now, as of the sponsor's last update on 11 Jul 2024. 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 Chile. 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 Rodrigo Araneda, PhD (+56 22 6618608, rodrigo.araneda@unab.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Gross Motor Function (time frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)). 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 11 Jul 2024.

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