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

University of Jaén

Status: Active, not recruiting

Conditions: ACV

Treatments: Other: Lokomat intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06840366

*University of Jaén.

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Control Group

No Intervention group

Description:

This group will receive the conventional treatment used in post-stroke rehabilitation. Conventional treatment will consist of a set of physiotherapy techniques including mobility exercises, muscle strengthening, balance stimulation and training of daily living activities, with the aim of improving motor function and mobility. In addition, standard interventions for the management of spasticity and pain will be integrated, according to the needs of each patient.

Lokomat Group

Experimental group

Description:

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.

Treatment:

Other: Lokomat intervention