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CompletedNCT06840366Updated Aug 20, 2025

Motor Rehabilitation and Physical, Mental and Cognitive Health in Patients With Stroke

An interventional study of Lokomat intervention in ACV, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by University of Jaén · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study analyzes the effectiveness of a motor rehabilitation program in the functional recovery of stroke patients and its impact physiotherapy, occupational therapy, and neuropsychology are used to measure improvements in balance, mobility, independence in daily activities, and cognitive functions. The intervention involves the use of the Lokomat, a technologically advanced robot-assisted gait training device. Patients are supported in a harness on a treadmill while the robotic system guides their legs through a natural gait cycle. The results will help clarify the relationship between motor recovery and overall well-being, providing evidence to optimize therapeutic strategies for stroke patients.

02

Conditions studied

  • ACV
03

In context

Lead sponsor

University of Jaén is the lead sponsor of 79 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of ischemic or hemorrhagic stroke.
  • Age equal to or greater than 18 years.
  • Patients in the subacute or chronic phase of stroke (≥ 3 months since the event).
  • Ability to participate in a motor rehabilitation program.
  • Absence of advanced neurodegenerative diseases that may interfere with the evaluation of results.
  • Ability to understand and follow basic instructions of the rehabilitation program.
  • Informed consent signed by the patient or his/her legal representative.

Exclusion criteria

Exclusion Criteria:

  • People under 60 years of age.
  • Presence of serious comorbidities that prevent physical activity or rehabilitation (e.g. severe heart failure, advanced chronic obstructive pulmonary disease).
  • Patients with severe cognitive impairments that make it difficult to follow the program (e.g. advanced dementia).
  • Use of drugs that significantly affect motor and cognitive function, interfering with the evaluation of rehabilitation.
  • Presence of active infections or unstable medical conditions requiring hospitalization.
  • History of another neurological disorder that may affect functional recovery (e.g. Parkinson's disease, multiple sclerosis).
  • Participation in another rehabilitation program at the same time, which may interfere with the results of the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Lokomat Group

    The intervention group will be composed of patients who have suffered a stroke and have alterations in mobility, balance and gait. These patients will be selected according to inclusion criteria such as clinical stability and ability to participate in a rehabilitation program. The group will receive structured physiotherapy sessions with a progressive approach to improve postural control, muscle strength, coordination and functional independence.

    Other: Lokomat intervention

Interventions

  • OtherLokomat intervention

    The intervention will consist of an 8-week motor rehabilitation program, with 3 weekly sessions of 60 minutes each. In the first weeks, joint mobilization and postural control in a sitting position will be worked on, followed by muscle strengthening and balance re-education in a standing position. Subsequently, coordination exercises and assisted walking on different surfaces will be incorporated. In the final phase, independent walking and the integration of functional movements in daily life activities will be encouraged. The program will be adapted to the individual needs of each patient to optimize recovery and improve quality of life.

06

What researchers measure

Primary outcomes

  1. Balance

    The Berg Scale is a widely used tool for assessing static and dynamic balance in adults with neuromotor impairments. It consists of 14 items that assess various functional tasks, such as standing, transferring, trunk rotation, and turning gait. Each item is scored on an ordinal scale from 0 to 4, with 0 indicating the lowest functional capacity and 4 indicating independent and safe performance of the task, with a maximum total score of 56 points. Scores below 45 are associated with an increased risk of falls. This scale has demonstrated high interobserver reliability (ICC \> 0.95) and concurrent validity in stroke patients.

    Time frame: Up to twelve weeks

  2. Postural Control

    The Postural Assessment Scale for Stroke Patients (PASS) is specifically designed to assess postural control in stroke patients, both in the acute and chronic phases. It includes 12 items that assess postural maintenance and changes in different positions (recumbent, sitting, and standing). Each item is scored from 0 to 3, with a maximum total score of 36 points. The PASS is particularly sensitive for detecting small functional changes during the early stages of post-stroke recovery and has demonstrated good discriminative and predictive validity for the evolution of postural control and gait. Its use is recom-mended for monitoring clinical progress in the rehabilitation setting.

    Time frame: Up to twelve weeks

  3. Functional Independence

    The Barthel Index is a commonly used instrument for measuring functional inde-pendence in basic activities of daily living (BADL). It assesses a patient's ability to perform 10 activities, including feeding, dressing, toileting, mobility, and climbing and descending stairs, among others. Scoring varies by task, with a maximum of 100 points awarded, with higher scores indicating greater autonomy. The BI is sensitive to clinical changes after rehabilitation interventions and has high reliability (α \> 0.90). It is widely used in clinical research with neurological populations, including post-stroke patients.

    Time frame: Up to twelve weeks

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Study locations

1 site
  • Agustín Aibar Almazán
    Jaén, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06840366
Lead sponsor
University of Jaén
Responsible party
Agustín Aibar Almazán (Principal investigator, University of Jaén) — Principal investigator
First posted
Feb 21, 2025
Start date
Mar 13, 2025
Primary completion
Mar 20, 2025
Completion
May 17, 2025
Last update
Aug 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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