Ischemic StrokeNCT04910217

Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke

A study testing Conventional rehabilitation, Leg/lower body exerciser device intervention. and Lokomat intervention in people with Ischemic Stroke, run by University Hospital Ostrava at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Robot-assisted gait training (RAGT) represents a modern concept of neurorehabilitation in stroke patients. This single-center randomized parallel-group neurorehabilitation trial with blinded primary outcome assessment is aimed at patients after the first-ever ischaemic stroke in the anterior or posterior cerebral… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke
What is being tested?: Conventional rehabilitation, Leg/lower body exerciser device intervention. and Lokomat intervention
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteCzechia
Study dates: 1 May 2022to Dec 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

signed informed consent by the participant or legal representative
interval between stroke and first rehabilitation session < 6 weeks (study target within 2 weeks)
age > 18 years
early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1)
early FAC of 0 to 3 (pre-stroke FAC of 5)
standing ability with support up to 3 minutes and vertical tolerance > 15 minutes

Who cannot join

inability or refusal to sign an informed consent
history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury)
severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder
limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale
impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device
limitations given by the Lokomat exoskeleton device (weight > 135 kg, thigh-length 23-35 cm, shank length 35-47cm)
limitations given by the leg/lower body exerciser (weight > 180 kg, height < 120 cm or > 200 cm, (sub)acute lower limb fractures, deep vein thrombosis, skin disintegration)
any contraindication to perform brain MRI

Trial locations and contacts

1 site in 1 country.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

Czechia1 site, 1 recruiting

University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Ondrej Volny, MD,PhD,FESO
Recruiting

Other trials in Czechia

About this study

Read the detailed description

The main aim is to determine, whether the RAGT by using the Lokomat exoskeleton device (Hoccoma, Switzerland) plus the protocol-defined conventional rehabilitation versus conventional rehabilitation improves the gait of post-stroke patients after 6 months. Both groups are treated with the protocol-defined rehabilitation (ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min). The Lokowalkers group undergoes the RAGT using the Lokomat Pro Freed device for 20-50 minutes 5 times a week for a total of 15 times for 3 weeks (a total of 1800 minutes). The primary endpoint is the Functional Ambulation Category (FAC) after 3 months. Secondary endpoints include FAC (after 15th therapy), 10-meter walk test (10MWT) (after 15th therapy, after 3 months), Timed Up and Go Test (TUG) (after 15th therapy and after 3 months, 3-months modified Rankin Scale (mRS), and Berg Balance Scale (BBS, after 15th therapy, after 3 months).

Conditions: Ischemic Stroke
Being tested: Conventional rehabilitation, Leg/lower body exerciser device intervention., Lokomat intervention
Keywords: gait, stroke, robotic rehabilitation, exoskeleton, neurorehabilitation, Lokomat
Medical subject headings: Ischemic Stroke, Stroke

What participants receive

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

Conventional rehabilitationProcedure or surgery
Patients will undergo conventional rehabilitation
Leg/lower body exerciser device intervention.Procedure or surgery
Patients will undergo leg/lower body exerciser device therapy.
Lokomat interventionProcedure or surgery
Patients will undergo therapy with Lokomat Pro FreeD device intervention.

Study groups in NCT04910217
Study group	Role	What they receive
Lokomat intervention	Experimental	Patients randomized into the Lokomat arm will undergo therapy with Lokomat Pro FreeD for 20-50 minutes 5-times a week, a total of 15-times during the in-hospital stay in a total time of 1,800 minutes. Receives: Procedure: Conventional rehabilitation; Procedure: Lokomat intervention
Conventional rehabilitation	Experimental	Patients in this arm will undergo conventional rehabilitation ((ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min) Receives: Procedure: Conventional rehabilitation; Procedure: Leg/lower body exerciser device intervention.

What is being measured

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

Functional Ambulation Category (FAC) at 3 months
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.
Measured: 3 months

Secondary outcomes (9)

Functional Ambulation Category (FAC) (after 3 weeks)
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.
Measured: 3 weeks
10-meter walk test (10-MWT) (after 3 weeks and 3 months)
10-meter walk test will be performed after 3 weeks and 3 months
Measured: up to 3 months
Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)
Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months
Measured: up to 3 months
3-months modified Rankin Scale (mRS)
3-months modified Rankin Scale (mRS) assesses the functional independence and represents a standard outcome measure in post-stroke patients (range from 0 to 6).
Measured: up to 3 months
Berg Balance Scale (BBS, after 3 weeks, after 3 months)
Berg Balance Scale (BBS) objectifies balance functions in 14 tasks. It assesses the risk of possible falls: 0-20 high, 21-40 medium, 41-56 low risk of falling.
Measured: up to 3 months
Adverse effects
The number and character of adverse effects will be observed during the study.
Measured: up to 3 years
Early termination of the study
The number of patients terminating the study early will be observed during the study.
Measured: up to 3 years
Reason/s for the termination
The reason/s for the termination will be observed during the study.
Measured: up to 3 years
Study-related death or death unrelated to study
The number of study-related deaths or deaths unrelated to study will be observed during the study.
Measured: up to 3 years

Timeline

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

1 May 2022Dec 2025

First posted2 Jun 2021
Study start1 May 2022
Primary completionDec 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 (22)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies 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: Randomised
Intervention model: Parallel groups
Model description: Single-centre randomized parallel group neurorehabilitation trial
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04910217
Sponsor's protocol ID: FNO-Lokowalkers-2021
Status last verified: Sep 2023
First submitted: 20 May 2021
Last updated: 21 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
PubMed 17908575
Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1.
PubMed 21964750
Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PubMed 27145936
Maier M, Ballester BR, Verschure PFMJ. Principles of Neurorehabilitation After Stroke Based on Motor Learning and Brain Plasticity Mechanisms. Front Syst Neurosci. 2019 Dec 17;13:74. doi: 10.3389/fnsys.2019.00074. eCollection 2019.
PubMed 31920570
Morone G, Paolucci S, Cherubini A, De Angelis D, Venturiero V, Coiro P, Iosa M. Robot-assisted gait training for stroke patients: current state of the art and perspectives of robotics. Neuropsychiatr Dis Treat. 2017 May 15;13:1303-1311. doi: 10.2147/NDT.S114102. eCollection 2017.
PubMed 28553117
Moucheboeuf G, Griffier R, Gasq D, Glize B, Bouyer L, Dehail P, Cassoudesalle H. Effects of robotic gait training after stroke: A meta-analysis. Ann Phys Rehabil Med. 2020 Nov;63(6):518-534. doi: 10.1016/j.rehab.2020.02.008. Epub 2020 Mar 27.
PubMed 32229177
Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
PubMed 7811170
Bruni MF, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. What does best evidence tell us about robotic gait rehabilitation in stroke patients: A systematic review and meta-analysis. J Clin Neurosci. 2018 Feb;48:11-17. doi: 10.1016/j.jocn.2017.10.048. Epub 2017 Dec 6.
PubMed 29208476
Kim MS, Kim SH, Noh SE, Bang HJ, Lee KM. Robotic-Assisted Shoulder Rehabilitation Therapy Effectively Improved Poststroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1015-1022. doi: 10.1016/j.apmr.2019.02.003. Epub 2019 Mar 13.
PubMed 30878496
Mehrholz J, Thomas S, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD006185. doi: 10.1002/14651858.CD006185.pub5.
PubMed 33091160
Zaidi SF, Aghaebrahim A, Urra X, Jumaa MA, Jankowitz B, Hammer M, Nogueira R, Horowitz M, Reddy V, Jovin TG. Final infarct volume is a stronger predictor of outcome than recanalization in patients with proximal middle cerebral artery occlusion treated with endovascular therapy. Stroke. 2012 Dec;43(12):3238-44. doi: 10.1161/STROKEAHA.112.671594. Epub 2012 Nov 15.
PubMed 23160876
Bucker A, Boers AM, Bot JCJ, Berkhemer OA, Lingsma HF, Yoo AJ, van Zwam WH, van Oostenbrugge RJ, van der Lugt A, Dippel DWJ, Roos YBWEM, Majoie CBLM, Marquering HA; MR CLEAN Trial Investigators (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). Associations of Ischemic Lesion Volume With Functional Outcome in Patients With Acute Ischemic Stroke: 24-Hour Versus 1-Week Imaging. Stroke. 2017 May;48(5):1233-1240. doi: 10.1161/STROKEAHA.116.015156. Epub 2017 Mar 28.
PubMed 28351963
Aurich-Schuler T, Gut A, Labruyere R. The FreeD module for the Lokomat facilitates a physiological movement pattern in healthy people - a proof of concept study. J Neuroeng Rehabil. 2019 Feb 6;16(1):26. doi: 10.1186/s12984-019-0496-x.
PubMed 30728040
Bower K, Thilarajah S, Pua YH, Williams G, Tan D, Mentiplay B, Denehy L, Clark R. Dynamic balance and instrumented gait variables are independent predictors of falls following stroke. J Neuroeng Rehabil. 2019 Jan 7;16(1):3. doi: 10.1186/s12984-018-0478-4.
PubMed 30612584
Heinemann AW, Linacre JM, Wright BD, Hamilton BB, Granger C. Relationships between impairment and physical disability as measured by the functional independence measure. Arch Phys Med Rehabil. 1993 Jun;74(6):566-73. doi: 10.1016/0003-9993(93)90153-2.
PubMed 8503745

Want to know more?

Jiří Hynčica

0042059737 ext. 2587

jiri.hyncica@fno.cz

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke
ClinicalTrials.gov ID: NCT04910217
Acronym / sponsor ID: FNO-Lokowalkers-2021
Conditions: Ischemic Stroke
Keywords: gait, stroke, robotic rehabilitation, exoskeleton, neurorehabilitation, Lokomat
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: University Hospital OstravaUniversity, hospital or other
Collaborators: Masaryk University, VSB - Technical University of Ostrava
Study start: 1 May 2022 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 2 Jun 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Single-centre randomized parallel group neurorehabilitation trial

Arm	Type	Receives
Lokomat intervention	Experimental	Procedure: Conventional rehabilitation, Procedure: Lokomat interventionPatients randomized into the Lokomat arm will undergo therapy with Lokomat Pro FreeD for 20-50 minutes 5-times a week, a total of 15-times during the in-hospital stay in a total time of 1,800 minutes.
Conventional rehabilitation	Experimental	Procedure: Conventional rehabilitation, Procedure: Leg/lower body exerciser device intervention.Patients in this arm will undergo conventional rehabilitation ((ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

signed informed consent by the participant or legal representative
interval between stroke and first rehabilitation session < 6 weeks (study target within 2 weeks)
age > 18 years
early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1)
early FAC of 0 to 3 (pre-stroke FAC of 5)

Key exclusion criteria (8 listed)

inability or refusal to sign an informed consent
history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury)
severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder
limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale
impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device

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
Conventional rehabilitationPatients will undergo conventional rehabilitation	Procedure or surgery	Conventional rehabilitation, Lokomat intervention
Leg/lower body exerciser device intervention.Patients will undergo leg/lower body exerciser device therapy.	Procedure or surgery	Conventional rehabilitation
Lokomat interventionPatients will undergo therapy with Lokomat Pro FreeD device intervention.	Procedure or surgery	Lokomat intervention

Primary outcome

Functional Ambulation Category (FAC) at 3 months
Time frame: 3 months
Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.

9 secondary outcomes

Functional Ambulation Category (FAC) (after 3 weeks)
Time frame: 3 weeks
10-meter walk test (10-MWT) (after 3 weeks and 3 months)
Time frame: up to 3 months
Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)
Time frame: up to 3 months
3-months modified Rankin Scale (mRS)
Time frame: up to 3 months
Berg Balance Scale (BBS, after 3 weeks, after 3 months)
Time frame: up to 3 months
Adverse effects
Time frame: up to 3 years
Early termination of the study
Time frame: up to 3 years
Reason/s for the termination
Time frame: up to 3 years
Study-related death or death unrelated to study
Time frame: up to 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Background: PubMed 17908575Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
Background: PubMed 21964750Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1.
Background: PubMed 27145936Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
Background: PubMed 31920570Maier M, Ballester BR, Verschure PFMJ. Principles of Neurorehabilitation After Stroke Based on Motor Learning and Brain Plasticity Mechanisms. Front Syst Neurosci. 2019 Dec 17;13:74. doi: 10.3389/fnsys.2019.00074. eCollection 2019.
Background: PubMed 28553117Morone G, Paolucci S, Cherubini A, De Angelis D, Venturiero V, Coiro P, Iosa M. Robot-assisted gait training for stroke patients: current state of the art and perspectives of robotics. Neuropsychiatr Dis Treat. 2017 May 15;13:1303-1311. doi: 10.2147/NDT.S114102. eCollection 2017.
Background: PubMed 32229177Moucheboeuf G, Griffier R, Gasq D, Glize B, Bouyer L, Dehail P, Cassoudesalle H. Effects of robotic gait training after stroke: A meta-analysis. Ann Phys Rehabil Med. 2020 Nov;63(6):518-534. doi: 10.1016/j.rehab.2020.02.008. Epub 2020 Mar 27.
Background: PubMed 7811170Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.
Background: PubMed 29208476Bruni MF, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. What does best evidence tell us about robotic gait rehabilitation in stroke patients: A systematic review and meta-analysis. J Clin Neurosci. 2018 Feb;48:11-17. doi: 10.1016/j.jocn.2017.10.048. Epub 2017 Dec 6.
Background: PubMed 30878496Kim MS, Kim SH, Noh SE, Bang HJ, Lee KM. Robotic-Assisted Shoulder Rehabilitation Therapy Effectively Improved Poststroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1015-1022. doi: 10.1016/j.apmr.2019.02.003. Epub 2019 Mar 13.
Background: PubMed 33091160Mehrholz J, Thomas S, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD006185. doi: 10.1002/14651858.CD006185.pub5.
Background: PubMed 23160876Zaidi SF, Aghaebrahim A, Urra X, Jumaa MA, Jankowitz B, Hammer M, Nogueira R, Horowitz M, Reddy V, Jovin TG. Final infarct volume is a stronger predictor of outcome than recanalization in patients with proximal middle cerebral artery occlusion treated with endovascular therapy. Stroke. 2012 Dec;43(12):3238-44. doi: 10.1161/STROKEAHA.112.671594. Epub 2012 Nov 15.
Background: PubMed 28351963Bucker A, Boers AM, Bot JCJ, Berkhemer OA, Lingsma HF, Yoo AJ, van Zwam WH, van Oostenbrugge RJ, van der Lugt A, Dippel DWJ, Roos YBWEM, Majoie CBLM, Marquering HA; MR CLEAN Trial Investigators (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). Associations of Ischemic Lesion Volume With Functional Outcome in Patients With Acute Ischemic Stroke: 24-Hour Versus 1-Week Imaging. Stroke. 2017 May;48(5):1233-1240. doi: 10.1161/STROKEAHA.116.015156. Epub 2017 Mar 28.
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.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

Ondřej Volný, MD,PhD,FESO principal investigator

University Hospital Ostrava

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 Czechia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Ambulation Category (FAC) at 3 months (time frame: 3 months). 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 NCT04910217, which also lists 22 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 21 Sep 2023.