ACVNCT06840366
Motor Rehabilitation and Physical, Mental and Cognitive Health in Patients With Stroke
A study testing Lokomat intervention in people with ACV, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACV
- What is being tested?
- Lokomat intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2025to 17 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Motor Rehabilitation Program and Its Impact on Functional Recovery, Mental and Cognitive Health in Patients With Stroke
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.
- Conditions
- ACV
- Being tested
- Lokomat intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lokomat Group | Experimental | 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. Receives: Other: Lokomat intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to twelve weeks
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.
Measured: Up to twelve weeks
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.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start13 Mar 2025
- Primary completion20 Mar 2025
- Study completion17 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840366
- Sponsor's protocol ID
- *University of Jaén.
- Status last verified
- Aug 2025
- First submitted
- 17 Feb 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Motor Rehabilitation Program and Its Impact on Functional Recovery, Mental and Cognitive Health in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06840366
- Acronym / sponsor ID
- *University of Jaén.
- Conditions
- ACV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 17 May 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lokomat Group | Experimental | Other: Lokomat interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lokomat interventionThe 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. | Other | Lokomat Group |
Primary outcome
Balance
Time frame: Up to twelve weeks
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.
Postural Control
Time frame: Up to twelve weeks
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.
Functional Independence
Time frame: Up to twelve weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
Related trials for ACV
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
Not yet recruiting
Clinical Study to Assess the Safety and Efficacy of ACV Moringa Effervescent Tablet Intake on Weight Management in Overweight and Class I Obese Study Participants
Obese or Overweight Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat intervention in people with ACV, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Up to twelve weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.