StrokeNCT06392802
Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase
A study testing Rehabilitation treatment using Muvity in people with Stroke and Motor Disorders, run by Universitat Politècnica de Catalunya at 2 sites in Spain.
Trial summary
Background: Stroke is the second leading cause of death worldwide and the primary medical cause of disability. It is estimated that 45% of affected individuals will continue to have moderate or severe functional disabilities throughout their lives. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Motor Disorders, Physical Disability
- What is being tested?
- Rehabilitation treatment using Muvity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2023to 30 Apr 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: between 18 and 85 years old.
- Stroke duration of more than six months + Discharge from post-stroke rehabilitation.
- Moderate physical disability: scoring between 1-3 on the Modified Rankin Scale.
- Standing: able to stand safely for 2 minutes without support (maximum score -4- on item 2 of the Berg Scale).
- Vision: capable of correctly visualizing a screen at a distance of 2 meters.
- Cognitive status: No cognitive impairment or mild cognitive impairment (Mini-Mental State Examination score ≥ 24). Ability to understand and follow verbal instructions in Catalan or Spanish.
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- Technological skills: capable of basic use of a mobile phone and computer (keyboard, mouse, screen).
- Glenohumeral joint mobility: minimum of 30º flexion, abduction, horizontal abduction; and 15º internal and external rotation.
- Elbow joint mobility: minimum of 45º flexion.
Who cannot join
- Engaging in intense physical therapies.
- Severe aphasia: inability or difficulty communicating through speech.
- Cognitive impairments affecting short and mid-term memory.
- Vision: having visual deficits in either eye that may impair screen visualization.
- Vision: experiencing hemispatial neglect, meaning difficulty processing stimuli on the side opposite to the injury.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universitat Politècnica de Catalunya
Barcelona, Barcelona, 08019
Associació Disminuïts Físics d'Osona
Vic, Barcelona, 08500
About this study
Background: Stroke is the second leading cause of death worldwide and the primary medical cause of disability. It is estimated that 45% of affected individuals will continue to have moderate or severe functional disabilities throughout their lives. According to the American Stroke Association, telerehabilitation has the potential to provide timely and efficient care to stroke survivors, improving patients' functional outcomes while reducing long-term disability and associated costs.
Hypothesis: Through the developed application (Muvity), the study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals in the post-stroke sequelae phase.
Read more
Objectives: To evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation for patients who have experienced a stroke more than 6 months ago.
Methodology: Prospective longitudinal study with single blinding. The control group undergoes a conventional intervention, while the experimental group undergoes an innovative intervention (n=25).
Variables: The collected variables and measurement tools include upper extremity functionality (Fugl-Meyer scale), balance (Berg), functional independence (Barthel), pain (Brief Pain Inventory), post-stroke quality of life (ECVI-38), emotional health (UCLA Self-Rating Depression Scale), treatment expectations (Expectation for Treatment Scale), treatment adherence (through an APP), and satisfaction (Telehealth Usability Questionnaire).
Statistical Analysis: Data will be analyzed per protocol (PP); the normality distribution of the data will be assessed, and results will be analyzed using parametric or non-parametric techniques depending on normality. A bivariate analysis will compare results between the control and intervention groups, considering a statistically significant result when p < 0.05.
Expected Results: Similar results are expected between groups or slightly favorable outcomes in the experimental group for the different variables.
Applicability and Relevance: The application would facilitate access to motor rehabilitation treatments in an enjoyable and engaging manner, promoting physical activity and contributing to a healthy lifestyle. Upon obtaining the results of this study, a trial implementation of the application in five socio-sanitary or associative centers is planned to verify its final applicability.
Read the detailed description
As described in the "Catalan Consensus on Evaluation and Treatment of Post-Stroke Patients," in the chronic phase when the effects of stroke have stabilized, patients should continue to have access to rehabilitation services to address their long-term needs. However, the decision to refer patients to rehabilitation services often relies heavily on patient and family demand, lacking clear criteria to ensure coordination between Primary Care services and specialized ones. Considering this gap in action, along with the estimated high costs associated with caring for stroke survivors, non-immersive virtual reality telerehabilitation is proposed as a beneficial tool for both patients and healthcare professionals and managers.
The study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals experiencing post-stroke sequelae.
Objectives (General and Specific)
The general objective of this study is to evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation targeting subjects who have suffered a stroke for more than six months, comparing the effectiveness of conventional therapy with gamified therapy (using the developed computational application).
The specific objectives of the study are as follows:
- Observe changes in joint range of motion (flexion, abduction, horizontal abduction of the shoulder, and elbow flexion) before and after the intervention.
- Assess if game performance (scores, time, etc.) changes between week 2 and week 12.
- Analyze the effects of the computational application on users' balance. Compare balance results between both groups.
- Measure the evolution of the pain variable before and after the intervention and compare it between the two groups.
- Explore potential changes in users' emotional health throughout the intervention.
- Determine the impact of the application on the user's quality of life (QoL).
- Verify if subjects' expectations are met through the application's use.
- Compare treatment adherence using the application versus conventional methodology.
- Determine if using the application leads to greater satisfaction in offering home rehabilitation guidance.
- Conditions
- Stroke, Motor Disorders, Physical Disability
- Being tested
- Rehabilitation treatment using Muvity
- Keywords
- post-stroke, telerehabilitation, non-immersive virtual reality
- Medical subject headings
- Stroke, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatment using MuvityDevice
The users have the support of the telerehabilitation system Muvity
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group follows a treatment similar to the one that a public hospital recommends. They receive a sheet of paper with the description of some exercises to do at home. These should be done in three 30-min-sessions per week, during 12 weeks. |
| Muvity - Intervention | Experimental | This group follows a treatment prescribed by a therapist using Muvity, a telerehabilitation system using a depth camera. The treatment consists of some exercises guided by a virtual avatar, and some exergames to play. The computer application monitors the ranges of motion of joint angles as well as time played and deviations from theoretical trajectories. These sessions are programmed to be done in three 30-min-sessions per week, during 12 weeks (same amount as the Control group). Receives: Device: Rehabilitation treatment using Muvity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer
Standard Fugl-Meyer score to assess motor functionality. Sections A (upper limbs, up to 36 points), D (coordination, up to 6 points), H (sensation, up to 6 points), I (joint movement (up to 16 points), and J (joint pain, up to 16 points). The total score could be up to 80 points (the higher score, the higher functionality).
Measured: Within one week before and within one week after the treatments for both groups.
Berg score
The Standard Berg Balance Scale is used to assess balance control. Scores range from 0 (equilibrium heavily affected) to 56 (excellent equilibrium capacity).
Measured: Within one week before and within one week after the treatments for both groups.
Brief Pain Inventory
Standard score to assess joint pain. It consists of 11 questions related to pain intensity. A score of 0 indicates pain absence, and 10 high pain intensity.
Measured: Within one week before and within one week after the treatments for both groups.
Ranges of motion
The ranges of motion of upper and lower limb joint angles are computed before and after the treatments for both control and intervention groups during the assessment face-to-face sessions. This information is also gathered for the intervention group during the 12-week treatment.
Measured: Within one week before and within one week after the treatment for both groups and during the 12-week treatment for the intervention group.
Secondary outcomes (4)
Ranges of motion
The ranges of motion of upper and lower limb joint angles are computed before and after the treatments for both control and intervention groups during the assessment face-to-face sessions. This information is also gathered for the intervention group during the 12-week treatment
Measured: During the 12-week treatment for the intervention group.
Time spent for the rehabilitation sessions
The time spent for the rehabilitation sessions is monitored for both groups (by a simple mobile app for the Control group and by Muvity for the intervention group)
Measured: During the 12-week treatment for the intervention group.
ECVI-38
Quality of life is monitored by the standard test ECVI-38. This stands for "Escala de calidad de vida para el ictus" (ECVI) in Spanish (Quality of Life Scale for Stroke), It ranges between 0 (no impairment) to 100 (maximum impairment).
Measured: Within one week before and within one week after the 12-week treatment
UCLA Self-Rating Depression Scale
Self-rating depression score. It ranges between 3 (low perception of loneliness) to 9 (high perception of loneliness).
Measured: Within one week before and within one week after the 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Mar 2023
- Primary completion28 Feb 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of 25 subjects follow a motor rehabilitation treatment during 12 weeks. One group (Control group) uses the typical rehabilitation process (just doing exercises at home, written on a sheet of paper). The intervention group uses the telerehabilitation system Muvity during 12 weeks at home to perform motor exercises and play exergames.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Politècnica de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Hospitalari de Vic, Institut Català de la Salut, EAP Vic (CAP Remei), Associació Disminuïts Físics d'Osona
- Responsible party
- Principal investigator, Gil Serrancolí, Universitat Politècnica de Catalunya
- Investigators
- Gil Serrancolí, PhD, Principal investigator, Universitat Politècnica de CatalunyaCris Molas, Msc, Principal investigator, Associació Disminuïts Físics d'Osona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392802
- Sponsor's protocol ID
- RehabAtHome_Osona
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We aim to disseminate the aggregated results. The identification of each participant will not be possible for the researchers who will use these data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase
- ClinicalTrials.gov ID
- NCT06392802
- Acronym / sponsor ID
- RehabAtHome_Osona
- Conditions
- Stroke, Motor Disorders, Physical Disability
- Keywords
- post-stroke, telerehabilitation, non-immersive virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universitat Politècnica de CatalunyaUniversity, hospital or other
- Collaborators
- Consorci Hospitalari de Vic, Institut Català de la Salut, EAP Vic (CAP Remei), Associació Disminuïts Físics d'Osona
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 30 Apr 2024 (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.
Background: Stroke is the second leading cause of death worldwide and the primary medical cause of disability. It is estimated that 45% of affected individuals will continue to have moderate or severe functional disabilities throughout their lives. According to the American Stroke Association, telerehabilitation has the potential to provide timely and efficient care to stroke survivors, improving patients' functional outcomes while reducing long-term disability and associated costs.
Hypothesis: Through the developed application (Muvity), the study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals in the post-stroke sequelae phase.
Objectives: To evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation for patients who have experienced a stroke more than 6 months ago.
Methodology: Prospective longitudinal study with single blinding. The control group undergoes a conventional intervention, while the experimental group undergoes an innovative intervention (n=25).
Variables: The collected variables and measurement tools include upper extremity functionality (Fugl-Meyer scale), balance (Berg), functional independence (Barthel), pain (Brief Pain Inventory), post-stroke quality of life (ECVI-38), emotional health (UCLA Self-Rating Depression Scale), treatment expectations (Expectation for Treatment Scale), treatment adherence (through an APP), and satisfaction (Telehealth Usability Questionnaire).
Statistical Analysis: Data will be analyzed per protocol (PP); the normality distribution of the data will be assessed, and results will be analyzed using parametric or non-parametric techniques depending on normality. A bivariate analysis will compare results between the control and intervention groups, considering a statistically significant result when p < 0.05.
Expected Results: Similar results are expected between groups or slightly favorable outcomes in the experimental group for the different variables.
Applicability and Relevance: The application would facilitate access to motor rehabilitation treatments in an enjoyable and engaging manner, promoting physical activity and contributing to a healthy lifestyle. Upon obtaining the results of this study, a trial implementation of the application in five socio-sanitary or associative centers is planned to verify its final applicability.
Detailed description
As described in the "Catalan Consensus on Evaluation and Treatment of Post-Stroke Patients," in the chronic phase when the effects of stroke have stabilized, patients should continue to have access to rehabilitation services to address their long-term needs. However, the decision to refer patients to rehabilitation services often relies heavily on patient and family demand, lacking clear criteria to ensure coordination between Primary Care services and specialized ones. Considering this gap in action, along with the estimated high costs associated with caring for stroke survivors, non-immersive virtual reality telerehabilitation is proposed as a beneficial tool for both patients and healthcare professionals and managers.
The study aims to contribute to the validity of telerehabilitation and virtual reality as beneficial tools for rehabilitation, specifically for individuals experiencing post-stroke sequelae.
Objectives (General and Specific)
The general objective of this study is to evaluate the effectiveness of a non-immersive virtual reality program in telerehabilitation targeting subjects who have suffered a stroke for more than six months, comparing the effectiveness of conventional therapy with gamified therapy (using the developed computational application).
The specific objectives of the study are as follows:
- Observe changes in joint range of motion (flexion, abduction, horizontal abduction of the shoulder, and elbow flexion) before and after the intervention.
- Assess if game performance (scores, time, etc.) changes between week 2 and week 12.
- Analyze the effects of the computational application on users' balance. Compare balance results between both groups.
- Measure the evolution of the pain variable before and after the intervention and compare it between the two groups.
- Explore potential changes in users' emotional health throughout the intervention.
- Determine the impact of the application on the user's quality of life (QoL).
- Verify if subjects' expectations are met through the application's use.
- Compare treatment adherence using the application versus conventional methodology.
- Determine if using the application leads to greater satisfaction in offering home rehabilitation guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Two groups of 25 subjects follow a motor rehabilitation treatment during 12 weeks. One group (Control group) uses the typical rehabilitation process (just doing exercises at home, written on a sheet of paper). The intervention group uses the telerehabilitation system Muvity during 12 weeks at home to perform motor exercises and play exergames.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group follows a treatment similar to the one that a public hospital recommends. They receive a sheet of paper with the description of some exercises to do at home. These should be done in three 30-min-sessions per week, during 12 weeks. |
| Muvity - Intervention | Experimental | Device: Rehabilitation treatment using MuvityThis group follows a treatment prescribed by a therapist using Muvity, a telerehabilitation system using a depth camera. The treatment consists of some exercises guided by a virtual avatar, and some exergames to play. The computer application monitors the ranges of motion of joint angles as well as time played and deviations from theoretical trajectories. These sessions are programmed to be done in three 30-min-sessions per week, during 12 weeks (same amount as the Control group). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: between 18 and 85 years old.
- Stroke duration of more than six months + Discharge from post-stroke rehabilitation.
- Moderate physical disability: scoring between 1-3 on the Modified Rankin Scale.
- Standing: able to stand safely for 2 minutes without support (maximum score -4- on item 2 of the Berg Scale).
- Vision: capable of correctly visualizing a screen at a distance of 2 meters.
Key exclusion criteria (5 listed)
- Engaging in intense physical therapies.
- Severe aphasia: inability or difficulty communicating through speech.
- Cognitive impairments affecting short and mid-term memory.
- Vision: having visual deficits in either eye that may impair screen visualization.
- Vision: experiencing hemispatial neglect, meaning difficulty processing stimuli on the side opposite to the injury.
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 |
|---|---|---|
| Rehabilitation treatment using MuvityThe users have the support of the telerehabilitation system Muvity | Device | Muvity - Intervention |
Primary outcome
Fugl-Meyer
Time frame: Within one week before and within one week after the treatments for both groups.
Standard Fugl-Meyer score to assess motor functionality. Sections A (upper limbs, up to 36 points), D (coordination, up to 6 points), H (sensation, up to 6 points), I (joint movement (up to 16 points), and J (joint pain, up to 16 points). The total score could be up to 80 points (the higher score, the higher functionality).
Berg score
Time frame: Within one week before and within one week after the treatments for both groups.
The Standard Berg Balance Scale is used to assess balance control. Scores range from 0 (equilibrium heavily affected) to 56 (excellent equilibrium capacity).
Brief Pain Inventory
Time frame: Within one week before and within one week after the treatments for both groups.
Standard score to assess joint pain. It consists of 11 questions related to pain intensity. A score of 0 indicates pain absence, and 10 high pain intensity.
Ranges of motion
Time frame: Within one week before and within one week after the treatment for both groups and during the 12-week treatment for the intervention group.
The ranges of motion of upper and lower limb joint angles are computed before and after the treatments for both control and intervention groups during the assessment face-to-face sessions. This information is also gathered for the intervention group during the 12-week treatment.
4 secondary outcomes
Ranges of motion
Time frame: During the 12-week treatment for the intervention group.
Time spent for the rehabilitation sessions
Time frame: During the 12-week treatment for the intervention group.
ECVI-38
Time frame: Within one week before and within one week after the 12-week treatment
UCLA Self-Rating Depression Scale
Time frame: Within one week before and within one week after the 12-week treatment
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 3 Sep 2026.
- Individual participant dataSharing planned: No. We aim to disseminate the aggregated results. The identification of each participant will not be possible for the researchers who will use these data.
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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.
Gil Serrancolí, PhD principal investigator
Universitat Politècnica de Catalunya
Cris Molas, Msc principal investigator
Associació Disminuïts Físics d'Osona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation treatment using Muvity in people with Stroke and Motor Disorders, run by Universitat Politècnica de Catalunya at 2 sites 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 9 inclusion and 5 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fugl-Meyer (time frame: Within one week before and within one week after the treatments for both groups.). The study lists 4 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 3 Sep 2026.