Multiple SclerosisNCT06615947
Conventional Multidisciplinary Gait Rehabilitation VR Robotic Self-balancing Based Gait Rehabilitation
A study testing Robotic gait training and tRHB in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.
Trial summary
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic
- What is being tested?
- Robotic gait training and tRHB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male or female, between 18 and 75 years of age.
- Confirmed diagnosis of MS.
- EDSS from 6.0 to 7.0.
- Able to maintain the upright position on a daily basis.
- Stable course of disease-modifying therapy over the past 6 months.
- Clinical comorbidity asymptomatic (i.e., no underlying cardiovascular disease)
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- Height: between approximately 1.50 m. and 1.90 m.
- Willingness to visit the Multiple Sclerosis Center of Catalonia (Cemcat) for testing and training.
- Gait disorder conditioned by paresis or hemiparesis associated with ataxia or sensory problems.
- Patient having given written consent.
- Atalante is able to accommodate the following limb lengths:
- Thigh: 380-460mm.
- Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
- 457-607mm for patient with an ankle dorsiflexion ≥ 16°
- 457-577mm for patient with an ankle dorsiflexion between 13° et 16°
- 457-567mm for patient with an ankle dorsiflexion between 10° et 13°
- 457-557mm for patient with an ankle dorsiflexion between 0° and 10°
- Hip with less or equal to 460mm when seated.
- Maximum weight: 90 kg.
Who cannot join
- • Pregnancy.
- Starting or switching from fampridine (Fampyra®) in the last 4 weeks.
- Height and weight outside the secure standard of safe use, described in the safety guides.
- Contraindications for Atalante training (eg, bone instability, history of osteoporosis or osteoporotic fractures).
- Subjects under Corticosteroids treatment or relapse.
- Changes in disease-modifying and symptomatic therapy for MS during the study period.
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- Subjects with psychiatric or cognitive comorbidities that may interfere with the trial.
- Whose joint centers cannot be aligned Atalante's.
- Ranges of motion below:
- Knee: 5° extension, 110° flexion
- Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
- Hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10°
- medial rotation, 20° lateral rotation
- Severe spasticity (greater than Ashworth 3) or uncontrolled clonus.
- Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores.
- Active implantable medical device.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centre d'Esclerosi Mútiple de Catalunya (Cemcat) - Barcelona, Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
About this study
Official title: Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
Read the detailed description
Aims
Primary Aim:
To compare the effect of Robot-Assisted Gait Training (RAGT) using the Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Secondary Aims:
- To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB), for improving static balance, dynamic balance, mobility, and self-perception of gait impairment measured with:
- Static Balance by the Berg Balance Scale (BBS), considering a clinically relevant change for improvement in balance as measured by BBS was +3 points, meaning that individuals are likely to perceive that as a reproducible and clinically important change in their balance performance.
- Dynamic balance by the Timed Up and Go test (TUG)
- Mobility measured by modified Rivermead Mobility Index (mRMI)
- Self-perception of gait impairment by Multiple Sclerosis Walking Scale-12 (MSWS-12)
- Instrumented gait analysis by the G-walk device (assessing gait cycle duration, step length, propulsion index, support phase percentage D/I, oscillation phase percentage D/I, double/unique support phase percentage).
- To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB) on quality of life, emotional status and fatigue measured at pre and post-intervention with:
- Multiple Sclerosis Quality of Life-54 (MSQoL 54 Health Survey Spanish version)
- Hospital Anxiety and Depression Scale (HADs) considering a clinically relevant change of 1.7 points at HADs
- The Modified fatigue scale (MFIS)
- The patient' physical effort of each session by means of the scale of perception of the effort R.P.E of Borg at the end of each training.
- To evaluate the epigenetic blueprint of rehabilitation training by comparing the genome wide chromatin accessibility of peripheral blood mononuclear cells (PBMCs) before and after RAGT or cRHB, by Assay for Transposase-Accessible Chromatin sequencing (ATACseq).
- To test the hypothesis that genome wide chromatin accessibility compared to clinical measures can be useful for identifying molecular mechanisms underlying rehabilitation therapies.
- To compare the changes induced by RAGT versus cRHB on the overall chromatin accessibility, and specific genome regions and pathways.
- Use the biological samples to provide additional functional and mechanistic information about the rehabilitation effects and subject health, disease or state.
Materials And methods
Design:
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)).
For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Additionally, peripheral blood (6ml) will be taken from all subjects at three timepoints: at baseline (T1), after the 8 weeks of rehabilitation treatment (T2) and, if possible, one year after T4. Biological samples will then be given a unique identifier and transferred to researchers for analysis.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
Enrollment and Screening Subjects will be evaluated for their eligibility from neurorehabilitation and neurology outpatient clinics at the Multiple Sclerosis Center of Catalonia (Cemcat).
Potential subjects will be referred to the study via Cemcat Physicians. A member of the research team will screen the referral and confirm they meet the necessary inclusion and exclusion criteria. Following confirmation of criteria, potential subjects will be contacted by phone to schedule an initial visit for consent and baseline assessment.
Additionally, peripheral blood (6ml) will also be taken from all subjects at baseline (T1).
Prior to all testing
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Being tested
- Robotic gait training, tRHB
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic gait trainingDevice
Also called Robotic, Atalante Gait Training
RAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'.
Progression will occur by increasing the number of steps in each session and decrease the level of assistance.
Participants will be secured with the appropriately sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5-minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
tRHBOther
Also called Physical therapy, gait training
Participants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly.
A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Gait Rehabilitation training (tRHB | Active comparator | Participants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly.
A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions. Receives: Other: tRHB |
| Robot Gait training (RAGT): | Experimental | RAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'.
Progression will occur by increasing the number of steps in each session and decrease the level of assistance.
Participants will be secured with the appropriately sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5-minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern. Receives: Device: Robotic gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed 10-meters walk test (10-MWT),
- To compare the effect of RAGT by use of Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start28 Feb 2023
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team. For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team. Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multiple Sclerosis Center of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin Roger Meza Murillo, Multiple Sclerosis Center of Catalonia
- Investigators
- Xavier Montalban, PHD, Study director, Multiple Sclerosis Center of CataloniaCarmen Tur Gomez, PHD, Study director, Multiple Sclerosis Center of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615947
- Sponsor's protocol ID
- PR(AG)05/2023
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare Conventional Multidisciplinary Gait Rehabilitation With the Atalante Self-balancing Walking System in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06615947
- Acronym / sponsor ID
- PR(AG)05/2023
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Multiple Sclerosis Center of CataloniaUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 27 Sep 2024 (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 trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
Detailed description
Aims
Primary Aim:
To compare the effect of Robot-Assisted Gait Training (RAGT) using the Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Secondary Aims:
- To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB), for improving static balance, dynamic balance, mobility, and self-perception of gait impairment measured with:
- Static Balance by the Berg Balance Scale (BBS), considering a clinically relevant change for improvement in balance as measured by BBS was +3 points, meaning that individuals are likely to perceive that as a reproducible and clinically important change in their balance performance.
- Dynamic balance by the Timed Up and Go test (TUG)
- Mobility measured by modified Rivermead Mobility Index (mRMI)
- Self-perception of gait impairment by Multiple Sclerosis Walking Scale-12 (MSWS-12)
- Instrumented gait analysis by the G-walk device (assessing gait cycle duration, step length, propulsion index, support phase percentage D/I, oscillation phase percentage D/I, double/unique support phase percentage).
- To compare the effect of RAGT using the Atalante self-balance exoskeleton with conventional Rehabilitation training (cRHB) on quality of life, emotional status and fatigue measured at pre and post-intervention with:
- Multiple Sclerosis Quality of Life-54 (MSQoL 54 Health Survey Spanish version)
- Hospital Anxiety and Depression Scale (HADs) considering a clinically relevant change of 1.7 points at HADs
- The Modified fatigue scale (MFIS)
- The patient' physical effort of each session by means of the scale of perception of the effort R.P.E of Borg at the end of each training.
- To evaluate the epigenetic blueprint of rehabilitation training by comparing the genome wide chromatin accessibility of peripheral blood mononuclear cells (PBMCs) before and after RAGT or cRHB, by Assay for Transposase-Accessible Chromatin sequencing (ATACseq).
- To test the hypothesis that genome wide chromatin accessibility compared to clinical measures can be useful for identifying molecular mechanisms underlying rehabilitation therapies.
- To compare the changes induced by RAGT versus cRHB on the overall chromatin accessibility, and specific genome regions and pathways.
- Use the biological samples to provide additional functional and mechanistic information about the rehabilitation effects and subject health, disease or state.
Materials And methods
Design:
This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)).
For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team.
For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team.
Additionally, peripheral blood (6ml) will be taken from all subjects at three timepoints: at baseline (T1), after the 8 weeks of rehabilitation treatment (T2) and, if possible, one year after T4. Biological samples will then be given a unique identifier and transferred to researchers for analysis.
Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
Enrollment and Screening Subjects will be evaluated for their eligibility from neurorehabilitation and neurology outpatient clinics at the Multiple Sclerosis Center of Catalonia (Cemcat).
Potential subjects will be referred to the study via Cemcat Physicians. A member of the research team will screen the referral and confirm they meet the necessary inclusion and exclusion criteria. Following confirmation of criteria, potential subjects will be contacted by phone to schedule an initial visit for consent and baseline assessment.
Additionally, peripheral blood (6ml) will also be taken from all subjects at baseline (T1).
Prior to all testing
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a prospective, randomized, rater-blinded study (cRHB (N=30) vs RAGT (N=30)). For the control group, this protocol includes 24 one-hour sessions of cRHB training during 8 weeks three times per week, under the supervision of a qualified rehab team. For the intervention group (RAGT) this protocol includes 24 one-hour sessions of RAGT during 8 weeks three times per week, under the supervision of a qualified rehab team. Informed consent will be obtained from patients prior to inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki.
| Arm | Type | Receives |
|---|---|---|
| Traditional Gait Rehabilitation training (tRHB | Active comparator | Other: tRHBParticipants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions. |
| Robot Gait training (RAGT): | Experimental | Device: Robotic gait trainingRAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'. Progression will occur by increasing the number of steps in each session and decrease the level of assistance. Participants will be secured with the appropriately sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5-minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- • Male or female, between 18 and 75 years of age.
- Thigh: 380-460mm.
- Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):
- Hip with less or equal to 460mm when seated.
- Maximum weight: 90 kg.
Key exclusion criteria (16 listed)
- • Pregnancy.
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 |
|---|---|---|
| Robotic gait trainingAlso: Robotic, Atalante Gait TrainingRAGT group, will be trained 3-times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. Training intensity will be monitored and standardized using the Borg Rating of Perceived Exertion scale, and will progress from 'fairly light' to 'somewhat hard'. Progression will occur by increasing the number of steps in each session and decrease the level of assistance. Participants will be secured with the appropriately sized harness and attached to an overhead body-weight support system. Each session will begin with a 3-5-minute warm-up in the continuous passive mode (cadence ~40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern. | Device | Robot Gait training (RAGT): |
| tRHBAlso: Physical therapy, gait trainingParticipants randomize to receive a tRHB, will be trained 3 times per week, with an intensity of 40 to 60 minutes, and duration over 8-weeks. Progression will occur by increasing the session intensity weekly. A standardized protocol based on the usual clinical practice of physiotherapy in people with multiple sclerosis will be follow, according to patient characteristics, to design the sessions based on the patient objectives to be achieved, choosing the type of specific exercises to be performed based on the patient's condition and with the possibility of adapting them to their evolution during the twenty-four sessions. | Other | Traditional Gait Rehabilitation training (tRHB |
Primary outcome
Timed 10-meters walk test (10-MWT),
Time frame: 2 months
- To compare the effect of RAGT by use of Atalante self-balance exoskeleton with conventional rehabilitation training (cRHB) for improving Walking speed measured by the Timed 10-meters walk test (10-MWT), considering a clinically relevant change an improvement of 20% of the velocity (m/s) with respect to the baseline assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- 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. This study is not recruiting at the moment.
Xavier Montalban, PHD study director
Multiple Sclerosis Center of Catalonia
Carmen Tur Gomez, PHD study director
Multiple Sclerosis Center of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic gait training and tRHB in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.
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 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 10-meters walk test (10-MWT), (time frame: 2 months). 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 22 Apr 2026.