Comparative Study of LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation.

NCT ID: NCT06970314

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Lokomat

-To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs.

stroke with the Lokomat® tool.

Group Type EXPERIMENTAL

Lokomat

Intervention Type DEVICE

Exoelectric walking aid for patients who have suffered a stroke

C-Mill

-To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs.

stroke with the C-Mill® tool.

Group Type ACTIVE_COMPARATOR

C-Mill

Intervention Type DEVICE

Exoelectric walking aid for patients who have suffered a stroke

Interventions

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Lokomat

Exoelectric walking aid for patients who have suffered a stroke

Intervention Type DEVICE

C-Mill

Exoelectric walking aid for patients who have suffered a stroke

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of stroke (haemorrhagic and/or ischaemic) by a specialist physician. specialist.
* Subjects who are cognitively capable and who sign the informed consent form.

Exclusion Criteria

* 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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica de Ávila

OTHER

Sponsor Role lead

Responsible Party

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JORGE VELAZQUEZ SAORNIL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Pontificia de Salamanca

Salamanca, , Spain

Site Status

Countries

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Spain

Central Contacts

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JORGE SAORNIL, PhD.

Role: CONTACT

655909940

JORGE Velázquez Saornil

Role: CONTACT

655909940

Facility Contacts

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JORGE Velázquez Saornil, PhD.

Role: primary

655909940

JORGE Velázquez Saornil

Role: backup

References

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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.

Reference Type RESULT
PMID: 30417724 (View on PubMed)

Wallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.

Reference Type RESULT
PMID: 26381192 (View on PubMed)

Park 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.

Reference Type RESULT
PMID: 30741699 (View on PubMed)

Callaly 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.

Reference Type RESULT
PMID: 26271048 (View on PubMed)

Other Identifiers

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06/05/2025

Identifier Type: -

Identifier Source: org_study_id

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