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

NCT07230470 | Recruiting

• 1 other identifier: 06/05/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Stroke; Quality of life; Spasticity

Outcome Measures

Primary Outcomes (2)

• quality of life scale

  QoL39 scale. 0 minimum - 100 maximum (higher scores mean a better outcome).

  12 weeks

• Spasticity index

  Tardieu scale 0 min - 5 max (higher scores mean a worse outcome).

  12 weeks

Study Arms (2)

Lokomat

EXPERIMENTAL

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

Device: Lokomat®

C-Mill

ACTIVE COMPARATOR

Exoelectric walking aid for patients who have suffered a stroke

Device: C-Mill

Interventions

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

Lokomat

C-Mill DEVICE

Exoelectric walking aid for patients who have suffered a stroke

C-Mill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia de Salamanca: lead

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, 37002, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 30417724 RESULT

• Celedova 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.

  PMID: 2638119 RESULT

• 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.

  PMID: 30741699 RESULT

• 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.

  PMID: 26271048 RESULT

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jorge V Velázquez Saornil, PhD.

CONTACT

655909940; jvelazquezsa@upsa.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Physiotherapy

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 9, 2025
• Primary Completion: February 25, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

ES (1)