Movement DisordersNCT06884956
High-tech Rehabilitation Impact on Muscle MRI
An observational study of Movement Disorders and Treatment, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The use of high-tech techniques is becoming increasingly popular in the rehabilitation field, where the use of exoskeletons, robots, virtual reality, etc. allow for customized rehabilitation protocols. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Movement Disorders, Treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2023to Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing high-tech rehabilitation treatment of the lower limb and control healthy subjects.
Who may be able to join
- patients undergoing high-tech rehabilitation treatment of the lower limb
- able to remain in a supine position for 30 minutes without moving
- able to follow instructions and communicate effectively with operators (e.g communicating fear and/or pain)
Who cannot join
- any contraindication to MRI examination
- presence of metal nails/protheses or objects near the thighs which will disrupt and/or induce distortion on the MR images
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of High-tech Rehabilitation Impact on Muscular Tissue Using MRI Derived Biomarkers
The use of high-tech techniques is becoming increasingly popular in the rehabilitation field, where the use of exoskeletons, robots, virtual reality, etc. allow for customized rehabilitation protocols. Moreover, their combination with virtual reality systems improves the patient's involvement increasing the effectiveness of the treatment, especially in the pediatric context.
Several literature studies confirmed the effectiveness of rehabilitation treatments in the pediatric field in terms of functional and physiologic scores (e.g. GMFM).
This study aims to use MRI to identify biomarkers for the morpho-functional characterization of skeletal muscle and for the evaluation of the effect of high-tech rehabilitation treatment on it.
Read the detailed description
The use of high-tech techniques is becoming increasingly popular in the rehabilitation field, where the use of exoskeletons, robots, virtual reality, etc. allow for very refined control of the rehabilitation process, making it more repeatable and, at the same time, more customization on the needs of the individual patient. Furthermore, the use of virtual reality and applications with video game-style scenarios increase the patient's involvement and active participation, one of the crucial factors for maximizing the effectiveness of rehabilitation treatment, especially in the pediatric field. Studies also conducted at our institute have widely demonstrated the effectiveness of rehabilitation treatments in the pediatric field. In a study conducted at the Bosisio Parini center on 23 patients with acquired brain injuries, rehabilitation treatment with RAGT (Robotic-Aided Gait Training) and physiotherapy led to a general improvement in walking patterns and functional activities. The rehabilitation protocol included an intensive 4-week program with 20 sessions of RAGT and 20 sessions of traditional physiotherapy. The improvement in functionality was evaluated through the administration of the Gross Motor Function Measures GMFM scale, scales D and E) and the "6 Minutes Walk test", while the gait pattern was evaluated through gait analysis, highlighting an improvement regarding cadence, speed and stride length. Another study also conducted at the Bosisio Parini center demonstrated the effectiveness of the RAGT treatment also in a population of patients suffering from infantile cerebral palsy. In this second study, the effect of the rehabilitation process on the plasticity of the central nervous system was also evaluated using Magnetic Resonance Imaging (MRI). The analysis of Diffusion Tensor Imaging (DTI) and brain volumetric data on a group of 16 patients reported no significant effects at the group level; however, by stratifying the patients on the basis of the degree of clinical improvement achieved it was possible to observe an increase in the Fractional Anisotropy (FA) value at the level of some brain bundles, including the corticospinal tracts. To date, few studies have been carried out to study the effect of high-tech rehabilitation treatments directly on the patient's muscle tissue and, consequently, to better identify the categories of patients who respond better to rehabilitation treatment with the same initial clinical condition. In this context, MRI is a very promising tool, as it allows a completely non-invasive in-vivo measurement of the state of muscle tissue, which can be repeated several times even in a short time without risks for the patient. In another study conducted at the Bosisio Parini centre, muscle MRI was used to characterize patients suffering from two different types of limb-girdle muscular dystrophy (2A, 2B). In a subsequent study, muscle MRI was used to study the effect of Duchenne muscular dystrophy on respiratory muscles. A multicenter study which also involved our institute demonstrated that the use of a standardized acquisition and processing protocol for muscle MRI leads both to a high degree of repeatability of the measurements calculated from the MRI images and to their temporal stability, a an indispensable feature for any longitudinal studies. In this sense, the collaboration between our institute and the Institute of Biomedical Technologies (ITB) of the CNR has led to the development of a multimodal muscle MR image registration algorithm to improve data analysis in longitudinal studies. This study therefore aims to use MRI to identify biomarkers for the morpho-functional characterization of skeletal muscle and for the evaluation of the effect of high-tech rehabilitation treatment on it. For this purpose, it is planned to recruit a heterogeneous population of patients undergoing high-tech rehabilitation treatment in a clinical setting who will be asked to undergo a multimodal muscle MRI before and after the rehabilitation process. These measures can provide a useful tool both to better characterize the chain of events that lead to an improvement in the patient's functionality and to identify which patients can benefit most from this treatment.
- Conditions
- Movement Disorders, Treatment
- Keywords
- Muscle MRI, High tech motion rehabilitation
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients undergoing a motion rehabilitation treatment by using high tech devices, i.e. GRAIL and/or Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume
Muscular fibre volume derived from T1W MR images
Measured: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
Fat Fraction
Measure of fat infiltration in the muscular tissue derived from DIXON MR images and quantified in the different fiber bundles
Measured: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
GMFM
Gross Motor Function Scale
Measured: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The GMFM scales will be administered close to the MRI scan sessions.
Secondary outcomes (1)
Fractional Anisotropy
Measure of structural integrity derived from Diffusion Weighted MR images (DWI)
Measured: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start13 Jun 2023
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Peruzzo, IRCCS Eugenio Medea
- Investigators
- Denis Peruzzo, PhD, Principal investigator, Scientific Institute IRCCS Eugenio Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884956
- Sponsor's protocol ID
- RC1020
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mastropietro A, Peruzzo D, Taccogna MG, Sanna N, Casali N, Nossa R, Biffi E, Ambrosini E, Pedrocchi A, Rizzo G. Multiparametric MRI Assessment of Morpho-Functional Muscle Changes Following a 6-Month FES-Cycling Training Program: Pilot Study in People With a Complete Spinal Cord Injury. JMIR Rehabil Assist Technol. 2025 Jan 16;12:e64825. doi: 10.2196/64825.
PubMed 39819652Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cerebral Palsy or Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):106-112. doi: 10.1016/j.apmr.2019.08.479. Epub 2019 Sep 25.
PubMed 31562873Piccinini L, Cimolin V, Storm F, Di Girolamo G, Biffi E, Galli M, Condoluci C. Quantification of the effects of robotic-assisted gait training on upper and lower body strategy during gait in diplegic children with Cerebral Palsy using summary parameters. Comput Methods Biomech Biomed Engin. 2022 Feb;25(2):140-147. doi: 10.1080/10255842.2021.1938009. Epub 2021 Jun 14.
PubMed 34121521Biffi E, Beretta E, Storm FA, Corbetta C, Strazzer S, Pedrocchi A, Ambrosini E. The Effectiveness of Robot- vs. Virtual Reality-Based Gait Rehabilitation: A Propensity Score Matched Cohort. Life (Basel). 2021 Jun 11;11(6):548. doi: 10.3390/life11060548.
PubMed 34208009Castelli E, Beretta E, De Tanti A, Arduini F, Biffi E, Colazza A, Di Pede C, Guzzetta A, Lucarini L, Maghini I, Mandala M, Nespoli M, Pavarelli C, Policastro F, Polverelli M, Rossi A, Sgandurra G, Boldrini P, Bonaiuti D, Mazzoleni S, Posteraro F, Benanti P, Draicchio F, Falabella V, Galeri S, Gimigliano F, Grigioni M, Mazzon S, Molteni F, Morone G, Petrarca M, Picelli A, Senatore M, Turchetti G, Saviola D. Robot-assisted rehabilitation for children with neurological disabilities: Results of the Italian consensus conference CICERONE. NeuroRehabilitation. 2022;51(4):665-679. doi: 10.3233/NRE-220036.
PubMed 36530098Peri E, Turconi AC, Biffi E, Maghini C, Panzeri D, Morganti R, Pedrocchi A, Gagliardi C. Effects of dose and duration of Robot-Assisted Gait Training on walking ability of children affected by cerebral palsy. Technol Health Care. 2017 Aug 9;25(4):671-681. doi: 10.3233/THC-160668.
PubMed 28436398Arrigoni F, De Luca A, Velardo D, Magri F, Gandossini S, Russo A, Froeling M, Bertoldo A, Leemans A, Bresolin N, D'angelo G. Multiparametric quantitative MRI assessment of thigh muscles in limb-girdle muscular dystrophy 2A and 2B. Muscle Nerve. 2018 Oct;58(4):550-558. doi: 10.1002/mus.26189. Epub 2018 Aug 22.
PubMed 30028523Schlaffke L, Rehmann R, Rohm M, Otto LAM, de Luca A, Burakiewicz J, Baligand C, Monte J, den Harder C, Hooijmans MT, Nederveen A, Schlaeger S, Weidlich D, Karampinos DC, Stouge A, Vaeggemose M, D'Angelo MG, Arrigoni F, Kan HE, Froeling M. Multi-center evaluation of stability and reproducibility of quantitative MRI measures in healthy calf muscles. NMR Biomed. 2019 Sep;32(9):e4119. doi: 10.1002/nbm.4119. Epub 2019 Jul 17.
PubMed 31313867
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of High-tech Rehabilitation Impact on Muscular Tissue Using MRI Derived Biomarkers
- ClinicalTrials.gov ID
- NCT06884956
- Acronym / sponsor ID
- RC1020
- Conditions
- Movement Disorders, Treatment
- Keywords
- Muscle MRI, High tech motion rehabilitation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Mar 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.
The use of high-tech techniques is becoming increasingly popular in the rehabilitation field, where the use of exoskeletons, robots, virtual reality, etc. allow for customized rehabilitation protocols. Moreover, their combination with virtual reality systems improves the patient's involvement increasing the effectiveness of the treatment, especially in the pediatric context.
Several literature studies confirmed the effectiveness of rehabilitation treatments in the pediatric field in terms of functional and physiologic scores (e.g. GMFM).
This study aims to use MRI to identify biomarkers for the morpho-functional characterization of skeletal muscle and for the evaluation of the effect of high-tech rehabilitation treatment on it.
Detailed description
The use of high-tech techniques is becoming increasingly popular in the rehabilitation field, where the use of exoskeletons, robots, virtual reality, etc. allow for very refined control of the rehabilitation process, making it more repeatable and, at the same time, more customization on the needs of the individual patient. Furthermore, the use of virtual reality and applications with video game-style scenarios increase the patient's involvement and active participation, one of the crucial factors for maximizing the effectiveness of rehabilitation treatment, especially in the pediatric field. Studies also conducted at our institute have widely demonstrated the effectiveness of rehabilitation treatments in the pediatric field. In a study conducted at the Bosisio Parini center on 23 patients with acquired brain injuries, rehabilitation treatment with RAGT (Robotic-Aided Gait Training) and physiotherapy led to a general improvement in walking patterns and functional activities. The rehabilitation protocol included an intensive 4-week program with 20 sessions of RAGT and 20 sessions of traditional physiotherapy. The improvement in functionality was evaluated through the administration of the Gross Motor Function Measures GMFM scale, scales D and E) and the "6 Minutes Walk test", while the gait pattern was evaluated through gait analysis, highlighting an improvement regarding cadence, speed and stride length. Another study also conducted at the Bosisio Parini center demonstrated the effectiveness of the RAGT treatment also in a population of patients suffering from infantile cerebral palsy. In this second study, the effect of the rehabilitation process on the plasticity of the central nervous system was also evaluated using Magnetic Resonance Imaging (MRI). The analysis of Diffusion Tensor Imaging (DTI) and brain volumetric data on a group of 16 patients reported no significant effects at the group level; however, by stratifying the patients on the basis of the degree of clinical improvement achieved it was possible to observe an increase in the Fractional Anisotropy (FA) value at the level of some brain bundles, including the corticospinal tracts. To date, few studies have been carried out to study the effect of high-tech rehabilitation treatments directly on the patient's muscle tissue and, consequently, to better identify the categories of patients who respond better to rehabilitation treatment with the same initial clinical condition. In this context, MRI is a very promising tool, as it allows a completely non-invasive in-vivo measurement of the state of muscle tissue, which can be repeated several times even in a short time without risks for the patient. In another study conducted at the Bosisio Parini centre, muscle MRI was used to characterize patients suffering from two different types of limb-girdle muscular dystrophy (2A, 2B). In a subsequent study, muscle MRI was used to study the effect of Duchenne muscular dystrophy on respiratory muscles. A multicenter study which also involved our institute demonstrated that the use of a standardized acquisition and processing protocol for muscle MRI leads both to a high degree of repeatability of the measurements calculated from the MRI images and to their temporal stability, a an indispensable feature for any longitudinal studies. In this sense, the collaboration between our institute and the Institute of Biomedical Technologies (ITB) of the CNR has led to the development of a multimodal muscle MR image registration algorithm to improve data analysis in longitudinal studies. This study therefore aims to use MRI to identify biomarkers for the morpho-functional characterization of skeletal muscle and for the evaluation of the effect of high-tech rehabilitation treatment on it. For this purpose, it is planned to recruit a heterogeneous population of patients undergoing high-tech rehabilitation treatment in a clinical setting who will be asked to undergo a multimodal muscle MRI before and after the rehabilitation process. These measures can provide a useful tool both to better characterize the chain of events that lead to an improvement in the patient's functionality and to identify which patients can benefit most from this treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients undergoing a motion rehabilitation treatment by using high tech devices, i.e. GRAIL and/or Lokomat |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing high-tech rehabilitation treatment of the lower limb and control healthy subjects.
Key inclusion criteria (3 listed)
- patients undergoing high-tech rehabilitation treatment of the lower limb
- able to remain in a supine position for 30 minutes without moving
- able to follow instructions and communicate effectively with operators (e.g communicating fear and/or pain)
Key exclusion criteria (2 listed)
- any contraindication to MRI examination
- presence of metal nails/protheses or objects near the thighs which will disrupt and/or induce distortion on the MR images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume
Time frame: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
Muscular fibre volume derived from T1W MR images
Fat Fraction
Time frame: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
Measure of fat infiltration in the muscular tissue derived from DIXON MR images and quantified in the different fiber bundles
GMFM
Time frame: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The GMFM scales will be administered close to the MRI scan sessions.
Gross Motor Function Scale
1 secondary outcome
Fractional Anisotropy
Time frame: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
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 19 Mar 2025.
- Background: PubMed 39819652Mastropietro A, Peruzzo D, Taccogna MG, Sanna N, Casali N, Nossa R, Biffi E, Ambrosini E, Pedrocchi A, Rizzo G. Multiparametric MRI Assessment of Morpho-Functional Muscle Changes Following a 6-Month FES-Cycling Training Program: Pilot Study in People With a Complete Spinal Cord Injury. JMIR Rehabil Assist Technol. 2025 Jan 16;12:e64825. doi: 10.2196/64825.
- Background: PubMed 31562873Beretta E, Storm FA, Strazzer S, Frascarelli F, Petrarca M, Colazza A, Cordone G, Biffi E, Morganti R, Maghini C, Piccinini L, Reni G, Castelli E. Effect of Robot-Assisted Gait Training in a Large Population of Children With Motor Impairment Due to Cerebral Palsy or Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):106-112. doi: 10.1016/j.apmr.2019.08.479. Epub 2019 Sep 25.
- Background: PubMed 34121521Piccinini L, Cimolin V, Storm F, Di Girolamo G, Biffi E, Galli M, Condoluci C. Quantification of the effects of robotic-assisted gait training on upper and lower body strategy during gait in diplegic children with Cerebral Palsy using summary parameters. Comput Methods Biomech Biomed Engin. 2022 Feb;25(2):140-147. doi: 10.1080/10255842.2021.1938009. Epub 2021 Jun 14.
- Background: PubMed 34208009Biffi E, Beretta E, Storm FA, Corbetta C, Strazzer S, Pedrocchi A, Ambrosini E. The Effectiveness of Robot- vs. Virtual Reality-Based Gait Rehabilitation: A Propensity Score Matched Cohort. Life (Basel). 2021 Jun 11;11(6):548. doi: 10.3390/life11060548.
- Background: PubMed 36530098Castelli E, Beretta E, De Tanti A, Arduini F, Biffi E, Colazza A, Di Pede C, Guzzetta A, Lucarini L, Maghini I, Mandala M, Nespoli M, Pavarelli C, Policastro F, Polverelli M, Rossi A, Sgandurra G, Boldrini P, Bonaiuti D, Mazzoleni S, Posteraro F, Benanti P, Draicchio F, Falabella V, Galeri S, Gimigliano F, Grigioni M, Mazzon S, Molteni F, Morone G, Petrarca M, Picelli A, Senatore M, Turchetti G, Saviola D. Robot-assisted rehabilitation for children with neurological disabilities: Results of the Italian consensus conference CICERONE. NeuroRehabilitation. 2022;51(4):665-679. doi: 10.3233/NRE-220036.
- Background: PubMed 28436398Peri E, Turconi AC, Biffi E, Maghini C, Panzeri D, Morganti R, Pedrocchi A, Gagliardi C. Effects of dose and duration of Robot-Assisted Gait Training on walking ability of children affected by cerebral palsy. Technol Health Care. 2017 Aug 9;25(4):671-681. doi: 10.3233/THC-160668.
- Background: PubMed 30028523Arrigoni F, De Luca A, Velardo D, Magri F, Gandossini S, Russo A, Froeling M, Bertoldo A, Leemans A, Bresolin N, D'angelo G. Multiparametric quantitative MRI assessment of thigh muscles in limb-girdle muscular dystrophy 2A and 2B. Muscle Nerve. 2018 Oct;58(4):550-558. doi: 10.1002/mus.26189. Epub 2018 Aug 22.
- Background: PubMed 31313867Schlaffke L, Rehmann R, Rohm M, Otto LAM, de Luca A, Burakiewicz J, Baligand C, Monte J, den Harder C, Hooijmans MT, Nederveen A, Schlaeger S, Weidlich D, Karampinos DC, Stouge A, Vaeggemose M, D'Angelo MG, Arrigoni F, Kan HE, Froeling M. Multi-center evaluation of stability and reproducibility of quantitative MRI measures in healthy calf muscles. NMR Biomed. 2019 Sep;32(9):e4119. doi: 10.1002/nbm.4119. Epub 2019 Jul 17.
- Individual participant dataSharing planned: Undecided
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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.
Denis Peruzzo, PhD principal investigator
Scientific Institute IRCCS Eugenio Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Treatment, run by IRCCS Eugenio Medea at 1 site in Italy.
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 2 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: enrolling by invitation, as of the sponsor's last update on 19 Mar 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 Italy. 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?
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?
Volume (time frame: Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.). The study lists 3 primary outcomes in all. 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 NCT06884956, which also lists 8 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 19 Mar 2025.