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

Not Applicable

Active, not recruiting

• Conditions: ACV

• Registration Number: NCT06840366
• Lead Sponsor: University of Jaén

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Study Start: 2025-03-13
• Primary Completion: 2025-03-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Study Completion: 2025-05-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PASS (Postural Assessment Scale for Stroke Patients)	Up to twelve weeks	To assess postural control in patients who have suffered a stroke. It consists of 12 items that measure the patient's ability to maintain balance in different postures. A high score indicates better postural balance and greater functional independence. The score is as follows: * 31-36: The patient has excellent postural control. 21-30: The patient has moderate postural control. Although he or she can perform several tasks, he or she still needs assistance in some situations.; * 11-20: The patient has significant deficits in postural control and needs considerable assistance to perform many tasks of daily living.; * 0-10: The patient has very poor postural control and is totally dependent on others to move or maintain his or her posture.
Ashworth (Modified Ashworth Scale - MAS)	Up to twelve weeks	It is used to measure muscle spasticity, which is an abnormal increase in muscle tone common in neurological disorders. It is scored on a scale of 0 to 4, where 0 indicates no spasticity and 4 represents severe stiffness. A high score indicates greater spasticity, which can make it difficult for the patient to move and function.
Timed Up and Go (TUG)	Up to twelve weeks	It assesses functional mobility and the risk of falls in older adults and patients with neurological conditions. It consists of measuring the time it takes the patient to get up from a chair, walk 3 meters, turn around, and return to sit down. A time greater than 13.5 seconds is associated with a higher risk of falls. It also assesses walking speed, used as an indicator of the patient's functionality and ability to move around. It is measured in meters per second (m/s) and may be affected in people with motor or neurological impairment. A speed of less than 0.8 m/s is associated with a higher risk of dependency and a lower ability to perform daily life activities.
DD/DI - WAIS IV (Forward/Reverse Digits - Wechsler Adult Intelligence Scale, IV Edition)	Up to twelve weeks	It assesses working memory, that is, the ability to retain and manipulate information temporarily. It consists of two tasks: i) Forward Digits (DD): the patient repeats a sequence of numbers in the same order in which they are presented; ii) Reverse Digits (DI): the patient repeats the numbers in reverse order. A low score indicates difficulties in working memory, which can affect planning, problem solving and attention.
The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Cubes Test	Up to twelve weeks	It assesses visuospatial skills and perceptual organization by reproducing patterns with colored cubes. It requires the integration of visual perception, motor coordination, and spatial reasoning. A low score indicates difficulties in perception, spatial construction, and planning, which may affect everyday tasks that require object manipulation and orientation in space. The scaled score ranges from 1 to 19 points.
TMT A / TMT B (Trail Making Test A and B)	Up to twelve weeks	It evaluates processing speed, selective attention and cognitive flexibility. It consists of two parts: i) TMT A: the patient connects numbers in sequential order (1-2-3...) as quickly as possible; ii) TMT B: the patient alternates between numbers and letters in sequential order (1-A-2-B-3-C...). A longer execution time indicates cognitive impairment, affecting executive functions and the ability to alternate between tasks.
SDMT Written/Verbal (Symbol Digit Modalities Test - Written/Verbal)	Up to twelve weeks	Measures cognitive processing speed and the ability to quickly associate symbols with numbers. The patient must match symbols with numbers following a given code, either in writing or verbally. A low score indicates cognitive slowing, which may reflect problems with attention, working memory, and speed in decision-making.
HADS (Hospital Anxiety and Depression Scale)	Up to twelve weeks	This scale is designed to assess anxiety (ANS) and depression (DEP) levels in hospitalized or outpatient patients. It consists of 14 items, divided into two subscales: i) Anxiety (HADS-A): measures anxiety symptoms, such as restlessness, excessive worry, and tension; ii) Depression (HADS-D): assesses depressive symptoms, such as anhedonia, fatigue, and low self-esteem. Each item is scored from 0 to 3, with a maximum of 21 points per subscale. A high score indicates greater anxiety and/or depression, being useful for the early detection of these disorders in patients with physical or neurological diseases, such as stroke.

Trial Locations

Locations (1)

Agustín Aibar Almazán; 🇪🇸 Jaén, Spain