Spinal Muscular Atrophy (SMA)NCT07488338
HABIT-ILE + FST in Children With SMA: Preliminary Effectiveness
A study testing Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST) in people with Spinal Muscular Atrophy (SMA), run by Teachers College, Columbia University at 1 site in United States.
Trial summary
This single-arm pilot study will assess the preliminary effectiveness of an intensive motor skill intervention (HABIT-ILE) combined with functional strength training (FST) in children with SMA who are receiving disease-modifying therapies. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Spinal Muscular Atrophy (SMA)
- What is being tested?
- Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a confirmed SMA diagnosis
- Be 5-17 years old
- Complete all pre- and post-intervention assessments
- Understand and speak English
- Follow instructions without major cognitive or behavioral issues
- Have received a stable disease-modifying therapy (DMT) dose for ≥6 months
- Be classified as a sitter or walker (SMA type 2 or 3) with supported standing ability (score ≥1 on Item 18 of the HFMSE) without KAFOs, AFOs, or external standing devices
Who cannot join
- Orthopedic surgery within the past year
- New pharmaceutical treatment during the study
- Concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Astrid Carton de Tournai, PhD contact
United States1 site, 1 recruiting
- Recruiting
Center for Cerebral Palsy Research, Teachers College, Columbia University
New York, New York, 10021
Astrid Carton de Tournai, PhD, (212) 678-3332, cpresearch@tc.columbia.edu
About this study
Official title: Feasibility and Preliminary Effectiveness of HABIT-ILE + Functional Strength Training in Children With Spinal Muscular Atrophy (SMA): a Prospective Single-group Intervention Trial.
This single-arm pilot study will assess the preliminary effectiveness of an intensive motor skill intervention (HABIT-ILE) combined with functional strength training (FST) in children with SMA who are receiving disease-modifying therapies. Participants will attend a HABIT-ILE + FST summer camp for 6 hours per day over a 3-week period, totaling 90 hours of training.
Read the detailed description
Spinal Muscular Atrophy (SMA) is a severe neuromuscular disorder marked by the progressive degeneration of alpha motor neurons in the spinal cord and brainstem, resulting in proximal muscle atrophy and weakness. Based on age of onset and the motor function achieved, children were historically categorized into functional groups. However, recent advances leading to the development of disease-modifying therapies (DMTs) have transformed the management of SMA. Outcomes are now primarily determined by the timing of DMT initiation, with early treatment-ideally before symptom onset-showing significant efficacy in improving motor function and survival. Despite these therapeutic breakthroughs, rehabilitation remains a cornerstone of care for children with SMA. Current clinical guidelines emphasize physical activity, muscle strengthening, and stretching. However, few studies have rigorously evaluated these interventions, and even fewer have examined their combined effects with DMTs. This gap underscores the need for innovative, evidence-based rehabilitation strategies that can complement pharmacological treatments and further promote functional outcomes. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is an intervention that integrates bimanual coordination with postural control and gross motor training. Grounded in motor skill learning principles, HABIT-ILE delivers high-intensity, structured practice of progressively increased motor difficulty tasks and functional activities, emphasizing voluntary active movement. The approach has demonstrated efficacy in children aged 6 months to 18 years with cerebral palsy (CP), a non-progressive neurodevelopmental disorder caused by early brain injury. Although SMA and CP differ in pathophysiology, both conditions involve motor impairments that may respond to intensive, task-specific motor training. In individuals with SMA, central neuroplastic mechanisms may help compensate for peripheral motor deficits, while targeted motor training could optimize recruitment and efficiency of residual motor units in the muscle. Strength training, in particular, has demonstrated beneficial effects in individuals with SMA, suggesting that emphasizing skill training requiring increasing endurance and progressively increasing the weights of objects participants handled, may be especially advantageous. In this context, augmenting HABIT-ILE with a functional strength training (FST) component tailored to individual goals may further enhance motor outcomes in this population. The aims of this prospective single-group intervention trial are to determine the effects of HABIT-ILE+FST on motor function in children with SMA receiving DMTs, and to assess retention of gains at 6 months, and to evaluate the effects of HABIT-ILE+FST on muscle fatigability using both clinical assessments and surface electromyography (sEMG). Participants will complete 90 hours of HABIT-ILE + FST training over a 3-week period (6 hours/day). It is hypothesized that this intervention will be well tolerated by children, enhance the acquisition of new motor skills, and foster greater functional independence in daily activities.
- Conditions
- Spinal Muscular Atrophy (SMA)
- Being tested
- Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)
- Keywords
- HABIT-ILE, Functional Strenght Training, Pediatric, Rehabilitation, Motor control, Intensive
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)Other
Goal-directed, task-specific training for both the upper and lower extremity, and postural control with targeted strengthening exercises to enhance motor control and facilitate the achievement of functional goals
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE + FST | Experimental | Participants receive a combined intervention consisting of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Functional Strength Training (FST). Both components are delivered as an integrated, intensive motor learning-based program aimed at improving upper and lower limb function in children with SMA. Subject will participate in a HABIT-ILE + FST camp format for 6 hours/day over 3 weeks. Receives: Other: Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hammersmith Functional Motor Scale - Expanded (HFMSE)
Gross motor function measure; range: 0 to 66; higher scores indicate better motor function
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Secondary outcomes (12)
Surface electromyography (sEMG)
Surface electromyography (sEMG) will be recorded from muscles of both lower extremities to assess rehabilitation-induced neuroplasticity and neuromuscular adaptations, including muscle fatigability and motor unit recruitment, during standardized endurance tasks.
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Revised Upper Limb Module (RULM)
Upper limb function measure; range: 0 to 37; higher scores indicate better uper limb function
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Endurance Shuttle box and blocks test (ESBBT)
Dexterity and upper extremity endurance/fatigability; range: O to 20 minutes (time to limitation); higher times correspond to better endurance
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
6-Minute Walk Test (6MWT)
Walking endurance measure; range: 0 meters to the maximim distance the participant can walk in 6 minutes; higher distances reflect better ambulatory function and endurance.
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
10 Meter Walking Test (10MWT)
Assesses gait speed by recording the time required to walk 10 meters, which is then expressed in meters per second. Scores range from 0 m/s (unable to walk) up to approximately 2 m/s in healthy individuals. Higher walking speed reflects better ambulatory function.
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Timed Up and Go (TUG)
Functional mobility and dynamic balance measure. The TUG measures the time required to rise from a chair, walk 3 meters, turn around, return, and sit down. The outcome is expressed in seconds, with lower times reflecting better functional mobility and balance.
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
30-Second Sit-to-Stand Test (30STS)
Lower limb strength and endurance measure; range: 0 (unable to stand) to higher values reflecting better lower limb strength and endurance
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Trunk Control Measurement Scale (TCMS)
Static and dynamic trunk control measure; range: 0 to 58 points; higher scores indicating better trunk control
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Spinal Muscular Atrophy EFFORT (SMA EFFORT)
Questionnaire of perceived physical fatigability (ages 12 years and older); different subscales; higher scores indicating greater perceived fatigue
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Canadian Occupational Performance Measure (COPM)
Interview of occupational performance and satisfaction; range: 1 to 10 for each item, with higher scores indicating better performance or greater satisfaction.
Measured: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Feasibility questionnaire
Feasibility questionnaire completed by both the child and their parents to assess the acceptability of the intervention (including child satisfaction and physical comfort, and parent feedback), as well as its demand and practicality.
Measured: Immediately after the intervention
Daily activity logs
Implementation feasibility measure
Measured: Every day during the intervention (assessed up to 15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start15 Mar 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Muscular Atrophy (SMA)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-group intervention trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488338
- Sponsor's protocol ID
- 25-429-2
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30.
PubMed 28133725Bleyenheuft Y, Gordon AM. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) for children with cerebral palsy. Phys Occup Ther Pediatr. 2014 Nov;34(4):390-403. doi: 10.3109/01942638.2014.932884. Epub 2014 Oct 1.
PubMed 25271469Mercuri E, Finkel RS, Muntoni F, Wirth B, Montes J, Main M, Mazzone ES, Vitale M, Snyder B, Quijano-Roy S, Bertini E, Davis RH, Meyer OH, Simonds AK, Schroth MK, Graham RJ, Kirschner J, Iannaccone ST, Crawford TO, Woods S, Qian Y, Sejersen T; SMA Care Group. Diagnosis and management of spinal muscular atrophy: Part 1: Recommendations for diagnosis, rehabilitation, orthopedic and nutritional care. Neuromuscul Disord. 2018 Feb;28(2):103-115. doi: 10.1016/j.nmd.2017.11.005. Epub 2017 Nov 23.
PubMed 29290580
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of HABIT-ILE + Functional Strength Training in Children With Spinal Muscular Atrophy (SMA): a Prospective Single-group Intervention Trial.
- ClinicalTrials.gov ID
- NCT07488338
- Acronym / sponsor ID
- 25-429-2
- Conditions
- Spinal Muscular Atrophy (SMA)
- Keywords
- HABIT-ILE, Functional Strenght Training, Pediatric, Rehabilitation, Motor control, Intensive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 2026 (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 single-arm pilot study will assess the preliminary effectiveness of an intensive motor skill intervention (HABIT-ILE) combined with functional strength training (FST) in children with SMA who are receiving disease-modifying therapies. Participants will attend a HABIT-ILE + FST summer camp for 6 hours per day over a 3-week period, totaling 90 hours of training.
Detailed description
Spinal Muscular Atrophy (SMA) is a severe neuromuscular disorder marked by the progressive degeneration of alpha motor neurons in the spinal cord and brainstem, resulting in proximal muscle atrophy and weakness. Based on age of onset and the motor function achieved, children were historically categorized into functional groups. However, recent advances leading to the development of disease-modifying therapies (DMTs) have transformed the management of SMA. Outcomes are now primarily determined by the timing of DMT initiation, with early treatment-ideally before symptom onset-showing significant efficacy in improving motor function and survival. Despite these therapeutic breakthroughs, rehabilitation remains a cornerstone of care for children with SMA. Current clinical guidelines emphasize physical activity, muscle strengthening, and stretching. However, few studies have rigorously evaluated these interventions, and even fewer have examined their combined effects with DMTs. This gap underscores the need for innovative, evidence-based rehabilitation strategies that can complement pharmacological treatments and further promote functional outcomes. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is an intervention that integrates bimanual coordination with postural control and gross motor training. Grounded in motor skill learning principles, HABIT-ILE delivers high-intensity, structured practice of progressively increased motor difficulty tasks and functional activities, emphasizing voluntary active movement. The approach has demonstrated efficacy in children aged 6 months to 18 years with cerebral palsy (CP), a non-progressive neurodevelopmental disorder caused by early brain injury. Although SMA and CP differ in pathophysiology, both conditions involve motor impairments that may respond to intensive, task-specific motor training. In individuals with SMA, central neuroplastic mechanisms may help compensate for peripheral motor deficits, while targeted motor training could optimize recruitment and efficiency of residual motor units in the muscle. Strength training, in particular, has demonstrated beneficial effects in individuals with SMA, suggesting that emphasizing skill training requiring increasing endurance and progressively increasing the weights of objects participants handled, may be especially advantageous. In this context, augmenting HABIT-ILE with a functional strength training (FST) component tailored to individual goals may further enhance motor outcomes in this population. The aims of this prospective single-group intervention trial are to determine the effects of HABIT-ILE+FST on motor function in children with SMA receiving DMTs, and to assess retention of gains at 6 months, and to evaluate the effects of HABIT-ILE+FST on muscle fatigability using both clinical assessments and surface electromyography (sEMG). Participants will complete 90 hours of HABIT-ILE + FST training over a 3-week period (6 hours/day). It is hypothesized that this intervention will be well tolerated by children, enhance the acquisition of new motor skills, and foster greater functional independence in daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-group intervention trial
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE + FST | Experimental | Other: Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)Participants receive a combined intervention consisting of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Functional Strength Training (FST). Both components are delivered as an integrated, intensive motor learning-based program aimed at improving upper and lower limb function in children with SMA. Subject will participate in a HABIT-ILE + FST camp format for 6 hours/day over 3 weeks. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Have a confirmed SMA diagnosis
- Be 5-17 years old
- Complete all pre- and post-intervention assessments
- Understand and speak English
- Follow instructions without major cognitive or behavioral issues
Key exclusion criteria (3 listed)
- Orthopedic surgery within the past year
- New pharmaceutical treatment during the study
- Concurrent participation in another clinical trial
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 |
|---|---|---|
| Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)Goal-directed, task-specific training for both the upper and lower extremity, and postural control with targeted strengthening exercises to enhance motor control and facilitate the achievement of functional goals | Other | HABIT-ILE + FST |
Primary outcome
Hammersmith Functional Motor Scale - Expanded (HFMSE)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Gross motor function measure; range: 0 to 66; higher scores indicate better motor function
12 secondary outcomes
Surface electromyography (sEMG)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Revised Upper Limb Module (RULM)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Endurance Shuttle box and blocks test (ESBBT)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
6-Minute Walk Test (6MWT)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
10 Meter Walking Test (10MWT)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Timed Up and Go (TUG)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
30-Second Sit-to-Stand Test (30STS)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Trunk Control Measurement Scale (TCMS)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Spinal Muscular Atrophy EFFORT (SMA EFFORT)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Canadian Occupational Performance Measure (COPM)
Time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up
Feasibility questionnaire
Time frame: Immediately after the intervention
Daily activity logs
Time frame: Every day during the intervention (assessed up to 15 weeks)
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 22 Oct 2026.
- Background: PubMed 28133725Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30.
- Background: PubMed 25271469Bleyenheuft Y, Gordon AM. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) for children with cerebral palsy. Phys Occup Ther Pediatr. 2014 Nov;34(4):390-403. doi: 10.3109/01942638.2014.932884. Epub 2014 Oct 1.
- Background: PubMed 29290580Mercuri E, Finkel RS, Muntoni F, Wirth B, Montes J, Main M, Mazzone ES, Vitale M, Snyder B, Quijano-Roy S, Bertini E, Davis RH, Meyer OH, Simonds AK, Schroth MK, Graham RJ, Kirschner J, Iannaccone ST, Crawford TO, Woods S, Qian Y, Sejersen T; SMA Care Group. Diagnosis and management of spinal muscular atrophy: Part 1: Recommendations for diagnosis, rehabilitation, orthopedic and nutritional care. Neuromuscul Disord. 2018 Feb;28(2):103-115. doi: 10.1016/j.nmd.2017.11.005. Epub 2017 Nov 23.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Muscular Atrophy (SMA)
Active, not recruitingObservational study
A Study of the Safety of Nusinersen (Spinraza®) and Its Effects on Motor Function in Koreans Living With SMA Treated During Their Usual Medical Care
Muscular Atrophy, Spinal
Recruiting
SMAdult - Monitoring of Movement on Spinal Muscular Atrophy
Spinal Amyotrophy
Active, not recruitingPhase 1
A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec
Healthy Volunteer, Muscular Atrophy, Spinal
Recruiting
Effects of Different Stiffness Settings During Robotic Isokinetic Training in Children With SMA
Spinal Muscular Atrophy (SMA)
RecruitingPhase 3
A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)
Muscular Atrophy, Spinal
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.
Astrid Carton de Tournai, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST) in people with Spinal Muscular Atrophy (SMA), run by Teachers College, Columbia University at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 22 Oct 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 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?
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 Andrew M Gordon, PhD (+1(212) 678-3332, ag275@tc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hammersmith Functional Motor Scale - Expanded (HFMSE) (time frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07488338, which also lists 3 linked publications.
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 22 Oct 2026.