Effectiveness of a Rehabilitation Exercise Plan at Home to Treat Post-stroke Patients in the Chronic Phase

NCT ID: NCT06392802

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-31

Brief 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. 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.

Conditions

Stroke; Motor Disorders; Physical Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Muvity - Intervention

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).

Group Type: EXPERIMENTAL

Rehabilitation treatment using Muvity

Intervention Type: DEVICE

The users have the support of the telerehabilitation system Muvity

Interventions

Rehabilitation treatment using Muvity

The users have the support of the telerehabilitation system Muvity

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Hospitalari de Vic

OTHER

Sponsor Role: collaborator

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

EAP Vic (CAP Remei)

UNKNOWN

Sponsor Role: collaborator

Associació Disminuïts Físics d'Osona

UNKNOWN

Sponsor Role: collaborator

Universitat Politècnica de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Gil Serrancolí

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gil Serrancolí, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Politècnica de Catalunya

Cris Molas, Msc

Role: PRINCIPAL_INVESTIGATOR

Associació Disminuïts Físics d'Osona

Locations

Associació Disminuïts Físics d'Osona

Vic, Barcelona, Spain

Site Status: RECRUITING

Universitat Politècnica de Catalunya

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Countries

Spain

Central Contacts

Gil Serrancolí, PhD

Role: CONTACT

gil.serrancoli@upc.edu

+34620372629

Cris Molas, Msc

Role: CONTACT

muvity.rehab@adfo.cat

Facility Contacts

Ariadna Pamplona, Msc

Role: primary

projectes@adfo.cat

+34682885675

Cris Molas, Msc

Role: backup

muvity.rehab@adfo.cat

Gil Serrancolí, PhD

Role: primary

gil.serrancoli@upc.edu

+34620372629

Other Identifiers

RehabAtHome_Osona

Identifier Type: -

Identifier Source: org_study_id