Cerebral PalsyNCT06767930
Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy
A study testing Hand and Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional intervention in people with Cerebral Palsy and Bilateral Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Bilateral Cerebral Palsy
- What is being tested?
- Hand and Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jan 2025to 31 Dec 2028
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed bilateral cerebral palsy,
- Adults aged 18 to 50 years old,
- Level of manual ability : level I to V of MACS
- Level of gross motor function : level I to IV of GMFCS
- Ability to follow instructions and complete testing,
- Ability to walk 10 meters independently without human assistance (technical aids such as orthoses or walking aids are permitted).
Who cannot join
- Unstable seizure
- Programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time
- Alcohol/drug abuse
- Pregnancy
- Severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion
- Uncontrolled health issues (cardiac, metabolic...)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Faculté des Sciences de la Motricité (UCLouvain)
Louvain-la-Neuve, Brabant-Wallon, 1348
Yannick Bleyenheuft, Professor, +32 2 764 93 49, yannick.bleyenheuft@uclouvain.be
About this study
Official title: Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy
This randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.
Read the detailed description
This randomized controlled trial (RCT) will investigate the impact of two weeks of HABIT-ILE therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (CP). Key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via EMG and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. This study aims to provide a comprehensive analysis of HABIT-ILE's effects especially on motor function, daily life activities and participation across a wide range of age.
- Conditions
- Cerebral Palsy, Bilateral Cerebral Palsy
- Being tested
- Hand and Arm Bimanual Intensive Therapy Including Lower Extremities, Conventional intervention
- Keywords
- cerebral palsy, motor skill learning, intensive therapy, body function, body structure, muscle structure, pain, activities, quality of life, adults
- Medical subject headings
- Cerebral Palsy, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand and Arm Bimanual Intensive Therapy Including Lower ExtremitiesBehavioural
The HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) program is an intensive rehabilitation therapy designed to improve motor functions and promote functional independence. Participants in this arm will engage in 6.5 hours of structured activities per day for two weeks (10 days). The therapy focuses on bimanual coordination combined with constant stimulation of the trunk and/or lower extremities, using task-oriented exercises tailored to individual goals. Each participant will be supported by one or two therapists and supervised by a trained team to ensure the program is delivered effectively and safely. The therapy emphasizes engaging, play-based activities to maximize motivation and active participation.
Conventional interventionBehavioural
Participants in the control group will continue their usual care, which includes conventional physical and occupational therapy, for a duration of two weeks. They will follow their regular therapy schedules without any changes to their routines or treatment habits. This approach ensures that the control group reflects standard rehabilitation practices, allowing for a direct comparison with the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE | Experimental | Not described Receives: Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities |
| Conventional intervention | Active comparator | Not described Receives: Behavioral: Conventional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gross Motor Function Measurement (GMFM-66)
Measurement of change in gross motor function over time in adults with cerebral palsy.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Secondary outcomes (24)
Changes in muscle strength (Biodex System 4 pro®)
Measurement of maximal isometric muscle strength for specific lower limb and upper limb muscles using a Biodex System 4 pro® (Biodex Medical Systems, Inc., Shirley, NY, USA) isokinetic device.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in muscle strength (Jamar)
Measurement of grip strength using the Jamar dynamometer.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in muscle range of motion (Biodex System 4 pro®)
Assessment of passive and active range of motion for targeted joints using the Biodex System 4 Pro® dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in neuromuscular command (muscle co-contraction)
Evaluation of muscles co-contraction in lower limbs and upper limbs by combining isometric force measurements with electromyography (EMG) recordings to monitor the activation patterns of agonist and antagonist muscles during contractions.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in unimanual dexterity (Box and Blocks Test - BBT)
Measurement of gross manual dexterity by counting how many blocks a participant can transfer from one side of a box to the other in one minute
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in the 2-Minutes' Walk Test (2MWT)
Measurement of the maximum distance covered by the patient in a 2-minutes' walk test, assessing the endurance and walking ability over a short duration.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in spinal function (electromyography - EMG)
Evaluation of spinal function through electromyography (EMG) during the 2-minutes' walk test, assessing muscle activation and coordination of the spinal cord during walking
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in pain perception (Quantitative Sensory Testing - QST)
Measurement of sensory response to determine pain threshold and pain perception.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily pain perception (Ecological Moment Assessment)
Ecological assessment of daily pain perception using a smartphone application sending randomized notifications throughout the day to prompt the patient to report their pain levels.
Measured: Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up
Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF)
Questionnaire assessing the severity of pain and its impact on functioning.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in neuropathic pain (PROMIS PQ-Neuro)
Questionnaire designed to identify patients likely experiencing neuropathic pain and to assess its severity.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in perception of pain (Pain Catastrophizing Scale - PCS)
Questionnaire assessing the extent of catastrophic thinking related to pain, including rumination, magnification, and helplessness, across three subscales. The total score ranges from 0 to 52 (higher scores indicate a greater degree of pain catastrophizing).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in coping strategies (Coping Strategies Questionnaire - CSQ-F)
Questionnaire assessing five cognitive coping strategies for managing pain-distraction (attention diversion), catastrophising, praying and hoping, ignoring pain sensations, and reinterpreting pain sensations-based on the frequency of use for each strategy.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in coping strategies (General Self-Efficacy Scale - GSES)
Questionnaire assessing the belief in one's ability to handle various difficult situations. Scores range from 10 to 40 (lower scores suggest reduced self-efficacy).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (Canadian Occupational Performance Measure - COPM)
The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10, a higher score means a better performance.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ABILHAND Questionnaire)
Questionnaire assessing the patient's performance in unimanual and bimanual upper limb activities, with scores ranging from -6 to +6 logits (higher score indicates better performance).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ACTIVLIM-CP Questionnaire)
Questionnaire assessing the patient's ability to perform daily activities using the upper and/or lower limbs, with scores ranging from -5 to +5 logits (higher scores indicates better performance).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ABILOCO questionnaire)
Questionnaire assessing the patient's ability to perform daily activities using the lower limbs, with scores ranging from -4 to +4 logits (higher scores indicates better performance)
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in participation (Participation in Life Situation Questionnaire - PILS)
Questionnaire assessing the participation and engagement in life situation, assessing how cerebral palsy affects the patient's ability to participate in various activities and social situations.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in psychological well-being (Hospital Anxiety and Depression Scale - HADS)
Questionnaire assessing the patient's level of anxiety and depression, with scores ranging from 0 to 21 for both subscales (higher scores indicate higher levels of anxiety of depression).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in pain and sleeping (Pain and Sleep Questionnaire 3 - PSQ-3)
Questionnaire assessing the impact of pain on sleep quality. Scores range from 0 to 30 (higher scores indicate greater disruption to sleep due to pain).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in fatigue (Multidimensional Fatigue Inventory - MFI)
Questionnaire assessing fatigue across five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Each subscale score ranges from 4 to 20 (higher scores indicate more severe fatigue in the respective domain).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in quality of life (WHOQOL-BREF)
Questionnaire assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Scores for each domain range from 4 to 20 (higher scores indicate better quality of life).
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in cognitive function (PROMIS Neuro-QOL Short Form Cognitive Function 2.0)
Questionnaire assessing perceived cognitive function, focusing on areas such as memory, attention, and problem-solving. It is a 4-item questionnaire, each item uses a 5-point Likert scale ranging from 1 ("Never") to 5 ("Always"), with higher scores indicating worse cognitive functioning.
Measured: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start6 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Université Catholique de LouvainThe 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
- The trial will be a single-blind, randomized controlled trial. Participants will be randomly assigned to one of two groups: a control group receiving conventional therapy or a treatment group participating in the HABIT-ILE therapy program. Longitudinal assessments will be conducted the week before the intervention, at the end of the two-week intervention and three months post-intervention.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Paris 12 Val de Marne University
- Responsible party
- Principal investigator, Yannick Bleyenheuft, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767930
- Sponsor's protocol ID
- B403201316810i
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06767930
- Acronym / sponsor ID
- B403201316810i
- Conditions
- Cerebral Palsy, Bilateral Cerebral Palsy
- Keywords
- cerebral palsy, motor skill learning, intensive therapy, body function, body structure, muscle structure, pain, activities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Paris 12 Val de Marne University
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jan 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 randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.
Detailed description
This randomized controlled trial (RCT) will investigate the impact of two weeks of HABIT-ILE therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (CP). Key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via EMG and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. This study aims to provide a comprehensive analysis of HABIT-ILE's effects especially on motor function, daily life activities and participation across a wide range of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will be a single-blind, randomized controlled trial. Participants will be randomly assigned to one of two groups: a control group receiving conventional therapy or a treatment group participating in the HABIT-ILE therapy program. Longitudinal assessments will be conducted the week before the intervention, at the end of the two-week intervention and three months post-intervention.
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE | Experimental | Behavioral: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities |
| Conventional intervention | Active comparator | Behavioral: Conventional intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed bilateral cerebral palsy,
- Adults aged 18 to 50 years old,
- Level of manual ability : level I to V of MACS
- Level of gross motor function : level I to IV of GMFCS
- Ability to follow instructions and complete testing,
Key exclusion criteria (6 listed)
- Unstable seizure
- Programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time
- Alcohol/drug abuse
- Pregnancy
- Severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion
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 |
|---|---|---|
| Hand and Arm Bimanual Intensive Therapy Including Lower ExtremitiesThe HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) program is an intensive rehabilitation therapy designed to improve motor functions and promote functional independence. Participants in this arm will engage in 6.5 hours of structured activities per day for two weeks (10 days). The therapy focuses on bimanual coordination combined with constant stimulation of the trunk and/or lower extremities, using task-oriented exercises tailored to individual goals. Each participant will be supported by one or two therapists and supervised by a trained team to ensure the program is delivered effectively and safely. The therapy emphasizes engaging, play-based activities to maximize motivation and active participation. | Behavioural | HABIT-ILE |
| Conventional interventionParticipants in the control group will continue their usual care, which includes conventional physical and occupational therapy, for a duration of two weeks. They will follow their regular therapy schedules without any changes to their routines or treatment habits. This approach ensures that the control group reflects standard rehabilitation practices, allowing for a direct comparison with the intervention group. | Behavioural | Conventional intervention |
Primary outcome
Changes in Gross Motor Function Measurement (GMFM-66)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Measurement of change in gross motor function over time in adults with cerebral palsy.
24 secondary outcomes
Changes in muscle strength (Biodex System 4 pro®)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in muscle strength (Jamar)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in muscle range of motion (Biodex System 4 pro®)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in neuromuscular command (muscle co-contraction)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in unimanual dexterity (Box and Blocks Test - BBT)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in the 2-Minutes' Walk Test (2MWT)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in spinal function (electromyography - EMG)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in pain perception (Quantitative Sensory Testing - QST)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily pain perception (Ecological Moment Assessment)
Time frame: Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up
Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in neuropathic pain (PROMIS PQ-Neuro)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in perception of pain (Pain Catastrophizing Scale - PCS)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in coping strategies (Coping Strategies Questionnaire - CSQ-F)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in coping strategies (General Self-Efficacy Scale - GSES)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (Canadian Occupational Performance Measure - COPM)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ABILHAND Questionnaire)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ACTIVLIM-CP Questionnaire)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in daily activities (ABILOCO questionnaire)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in participation (Participation in Life Situation Questionnaire - PILS)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in psychological well-being (Hospital Anxiety and Depression Scale - HADS)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in pain and sleeping (Pain and Sleep Questionnaire 3 - PSQ-3)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in fatigue (Multidimensional Fatigue Inventory - MFI)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in quality of life (WHOQOL-BREF)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Changes in cognitive function (PROMIS Neuro-QOL Short Form Cognitive Function 2.0)
Time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
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 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand and Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional intervention in people with Cerebral Palsy and Bilateral Cerebral Palsy, run by Université Catholique de Louvain at 1 site in Belgium.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jan 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 Belgium. 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 Yannick Bleyenheuft, Professor (+3227649349, yannick.bleyenheuft@uclouvain.be), 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 Measurement (GMFM-66) (time frame: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up). 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 Jan 2025.