StrokeNCT07230470
Comparative Study of LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation.
A study testing Lokomat® and C-Mill in people with Stroke, run by Universidad Pontificia de Salamanca at 1 site in Spain.
Trial summary
The use of robotic technology for the treatment of gait in neurological pathologies has provided different results in scientific evidence. In patients with some types of acquired brain damage, such as stroke, the use of Lokomat® therapy can bring improvements in aspects such as gait speed and balance, among other… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Lokomat® and C-Mill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke (haemorrhagic and/or ischaemic) by a specialist physician. .
- Subjects who are cognitively capable and who sign the informed consent form.
Who cannot join
- Severe cognitive impairment (Mini-Mental State Examination < 24.), or impairment that prevents correct understanding of the correct understanding of the messages and explanatory orders of the treatment and its conditions.
- Diagnosis of concomitant neurological diseases and craniocerebral trauma. cranioencephalic trauma.
- Other diseases that interfere with the gait process (e.g. disabling arthritis or arthrosis, other neurological diseases, other neurological diseases).
- disabling arthritis or osteoarthritis, other concomitant neurological diseases, etc.).
- Contraindications of the robotic tools themselves.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Pontificia de Salamanca
Salamanca, 37002
Jorge Velázquez Saornil, PhD., 923277000, jvelazquezsa@upsa.es
About this study
Official title: Comparative Study of Working With the LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation and Improvement of Quality of Life in Adult Stroke Patients. Randomised Clinical Trial.
The use of robotic technology for the treatment of gait in neurological pathologies has provided different results in scientific evidence. In patients with some types of acquired brain damage, such as stroke, the use of Lokomat® therapy can bring improvements in aspects such as gait speed and balance, among other parameters and report greater functional recovery in subacute patients with greater deterioration. Similarly, the use of another technological element such as the C-Mill® reports improvements in various aspects of ambulation and balance in gait treatments for stroke patients. Likewise, the impact on the person's recovery is not only beneficial for gait rehabilitation, but also improves the perception of well-being, which can be positive in the process of readaptation to daily life.
The effect of both treatments for gait rehabilitation in adults with stroke and their impact on quality of life in the neurorehabilitation clinic will be studied.
adults with stroke and their impact on quality of life at the Lescer neurorehabilitation clinic Lescer, Madrid (Spain). Participants will be assessed at baseline, 4 weeks, 8 weeks and 12 weeks.
- Conditions
- Stroke
- Being tested
- Lokomat®, C-Mill
- Keywords
- Stroke, Quality of life, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat®Device
To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs.
stroke with the C-Mill® tool
C-MillDevice
Exoelectric walking aid for patients who have suffered a stroke
| Study group | Role | What they receive |
|---|---|---|
| Lokomat | Experimental | To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs.
stroke with the Lokomat® tool. Receives: Device: Lokomat® |
| C-Mill | Active comparator | Exoelectric walking aid for patients who have suffered a stroke Receives: Device: C-Mill |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life scale
QoL39 scale. 0 minimum - 100 maximum (higher scores mean a better outcome).
Measured: 12 weeks
Spasticity index
Tardieu scale 0 min - 5 max (higher scores mean a worse outcome).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start9 Dec 2025
- Primary completion25 Feb 2026
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia de Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Velazquez, Universidad Pontificia de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230470
- Sponsor's protocol ID
- 06/05/2025
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lefeber N, De Keersmaecker E, Henderix S, Michielsen M, Kerckhofs E, Swinnen E. Physiological Responses and Perceived Exertion During Robot-Assisted and Body Weight-Supported Gait After Stroke. Neurorehabil Neural Repair. 2018 Dec;32(12):1043-1054. doi: 10.1177/1545968318810810. Epub 2018 Nov 12.
PubMed 30417724Celedova L, Krsiak M, Janku I. Immunomodulator adamantylamide dipeptide antagonizes benzodiazepine-induced rota-rod deficit in mice. Act Nerv Super (Praha). 1989 Dec;31(4):291-3. No abstract available.
PubMed 2638119Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. NeuroRehabilitation. 2019;44(1):37-41. doi: 10.3233/NRE-182467.
PubMed 30741699Callaly EL, Ni Chroinin D, Hannon N, Sheehan O, Marnane M, Merwick A, Kelly LA, Horgan G, Williams E, Harris D, Williams D, Moore A, Dolan E, Murphy S, Kelly PJ, Duggan J, Kyne L. Falls and fractures 2 years after acute stroke: the North Dublin Population Stroke Study. Age Ageing. 2015 Sep;44(5):882-6. doi: 10.1093/ageing/afv093. Epub 2015 Aug 12.
PubMed 26271048
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Working With the LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation and Improvement of Quality of Life in Adult Stroke Patients. Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT07230470
- Acronym / sponsor ID
- 06/05/2025
- Conditions
- Stroke
- Keywords
- Stroke, Quality of life, Spasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Pontificia de SalamancaUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 17 Nov 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 robotic technology for the treatment of gait in neurological pathologies has provided different results in scientific evidence. In patients with some types of acquired brain damage, such as stroke, the use of Lokomat® therapy can bring improvements in aspects such as gait speed and balance, among other parameters and report greater functional recovery in subacute patients with greater deterioration. Similarly, the use of another technological element such as the C-Mill® reports improvements in various aspects of ambulation and balance in gait treatments for stroke patients. Likewise, the impact on the person's recovery is not only beneficial for gait rehabilitation, but also improves the perception of well-being, which can be positive in the process of readaptation to daily life.
The effect of both treatments for gait rehabilitation in adults with stroke and their impact on quality of life in the neurorehabilitation clinic will be studied.
adults with stroke and their impact on quality of life at the Lescer neurorehabilitation clinic Lescer, Madrid (Spain). Participants will be assessed at baseline, 4 weeks, 8 weeks and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lokomat | Experimental | Device: Lokomat®To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs. stroke with the Lokomat® tool. |
| C-Mill | Active comparator | Device: C-MillExoelectric walking aid for patients who have suffered a stroke |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of stroke (haemorrhagic and/or ischaemic) by a specialist physician. .
- Subjects who are cognitively capable and who sign the informed consent form.
Key exclusion criteria (5 listed)
- Severe cognitive impairment (Mini-Mental State Examination < 24.), or impairment that prevents correct understanding of the correct understanding of the messages and explanatory orders of the treatment and its conditions.
- Diagnosis of concomitant neurological diseases and craniocerebral trauma. cranioencephalic trauma.
- Other diseases that interfere with the gait process (e.g. disabling arthritis or arthrosis, other neurological diseases, other neurological diseases).
- disabling arthritis or osteoarthritis, other concomitant neurological diseases, etc.).
- Contraindications of the robotic tools themselves.
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 |
|---|---|---|
| Lokomat®To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs. stroke with the C-Mill® tool | Device | Lokomat |
| C-MillExoelectric walking aid for patients who have suffered a stroke | Device | C-Mill |
Primary outcome
quality of life scale
Time frame: 12 weeks
QoL39 scale. 0 minimum - 100 maximum (higher scores mean a better outcome).
Spasticity index
Time frame: 12 weeks
Tardieu scale 0 min - 5 max (higher scores mean a worse outcome).
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 4 May 2026.
- Results publication: PubMed 30417724Lefeber N, De Keersmaecker E, Henderix S, Michielsen M, Kerckhofs E, Swinnen E. Physiological Responses and Perceived Exertion During Robot-Assisted and Body Weight-Supported Gait After Stroke. Neurorehabil Neural Repair. 2018 Dec;32(12):1043-1054. doi: 10.1177/1545968318810810. Epub 2018 Nov 12.
- Results publication: PubMed 2638119Celedova L, Krsiak M, Janku I. Immunomodulator adamantylamide dipeptide antagonizes benzodiazepine-induced rota-rod deficit in mice. Act Nerv Super (Praha). 1989 Dec;31(4):291-3. No abstract available.
- Results publication: PubMed 30741699Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. NeuroRehabilitation. 2019;44(1):37-41. doi: 10.3233/NRE-182467.
- Results publication: PubMed 26271048Callaly EL, Ni Chroinin D, Hannon N, Sheehan O, Marnane M, Merwick A, Kelly LA, Horgan G, Williams E, Harris D, Williams D, Moore A, Dolan E, Murphy S, Kelly PJ, Duggan J, Kyne L. Falls and fractures 2 years after acute stroke: the North Dublin Population Stroke Study. Age Ageing. 2015 Sep;44(5):882-6. doi: 10.1093/ageing/afv093. Epub 2015 Aug 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat® and C-Mill in people with Stroke, run by Universidad Pontificia de Salamanca 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 2 inclusion and 5 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 4 May 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?
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 Jorge V Velázquez Saornil, PhD. (655909940, jvelazquezsa@upsa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life scale (time frame: 12 weeks). The study lists 2 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 NCT07230470, which also lists 4 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 4 May 2026.