- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07230470
Comparative Study of LoKomat® Exoskeleton VS C-Mill® Treadmill for Gait Recovery in Rehabilitation.
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jorge V Velázquez Saornil, PhD.
- Phone Number: 655909940
- Email: jvelazquezsa@upsa.es
Study Locations
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Salamanca, Spain, 37002
- Recruiting
- Universidad Pontificia de Salamanca
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Contact:
- Jorge Velázquez Saornil, PhD.
- Phone Number: 923277000
- Email: jvelazquezsa@upsa.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of stroke (haemorrhagic and/or ischaemic) by a specialist physician. .
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lokomat
To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs. stroke with the Lokomat® tool. |
To compare the effectiveness of gait rehabilitation work in adult stroke patients using the Lokomat® tool vs. stroke with the C-Mill® tool |
|
Active Comparator: C-Mill
Exoelectric walking aid for patients who have suffered a stroke
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Exoelectric walking aid for patients who have suffered a stroke
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life scale
Time Frame: 12 weeks
|
QoL39 scale.
0 minimum - 100 maximum (higher scores mean a better outcome).
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12 weeks
|
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Spasticity index
Time Frame: 12 weeks
|
Tardieu scale 0 min - 5 max (higher scores mean a worse outcome).
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscle Spasticity
- Stroke
Other Study ID Numbers
- 06/05/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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