Clinical trial NCT06840366: Motor Rehabilitation and Physical, Mental and Cognitive Health in Patients With Stroke
Official title: Effectiveness of a Motor Rehabilitation Program and Its Impact on Functional Recovery, Mental and Cognitive Health in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACV
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: PASS (Postural Assessment Scale for Stroke Patients)
timeFrame: Up to twelve weeks
measure: Ashworth (Modified Ashworth Scale - MAS)
timeFrame: Up to twelve weeks
measure: Timed Up and Go (TUG)
timeFrame: Up to twelve weeks
measure: DD/DI - WAIS IV (Forward/Reverse Digits - Wechsler Adult Intelligence Scale, IV Edition)
timeFrame: Up to twelve weeks
measure: The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Cubes Test
timeFrame: Up to twelve weeks
measure: TMT A / TMT B (Trail Making Test A and B)
timeFrame: Up to twelve weeks
measure: SDMT Written/Verbal (Symbol Digit Modalities Test - Written/Verbal)
timeFrame: Up to twelve weeks
measure: HADS (Hospital Anxiety and Depression Scale)
timeFrame: Up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Agustín Aibar Almazán
Study officials:
References: