Clinical trial NCT06970314: Comparative Study of LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
quality of life
spasticity
Lead sponsor: Universidad Católica de Ávila
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: quality of life scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Spasticity index
timeFrame: 12 weeks.
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad Pontificia de Salamanca
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.