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

NCT06392802 | Recruiting

• 1 other identifier: RehabAtHome_Osona
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Motor Disorders; Physical Disability

Keywords

post-stroke; telerehabilitation; non-immersive virtual reality

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  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

  During the 12-week treatment for the intervention group.

• Time spent for the rehabilitation sessions

  During the 12-week treatment for the intervention group.

• ECVI-38

  Within one week before and within one week after the 12-week treatment

• UCLA Self-Rating Depression Scale

  Within one week before and within one week after the 12-week treatment

Study Arms (2)

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).

Device: Rehabilitation treatment using Muvity

Interventions

Rehabilitation treatment using Muvity DEVICE

The users have the support of the telerehabilitation system Muvity

Muvity - Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Male, female, non-binary
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Politècnica de Catalunya: lead
• Consorci Hospitalari de Vic: collaborator
• Institut Català de la Salut: collaborator
• EAP Vic (CAP Remei): collaborator
• Associació Disminuïts Físics d'Osona: collaborator

Study Sites (2)

Associació Disminuïts Físics d'Osona

Vic, Barcelona, 08500, Spain

RECRUITING

Universitat Politècnica de Catalunya

Barcelona, 08019, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Motor Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• Gil Serrancolí, PhD

  Universitat Politècnica de Catalunya

  PRINCIPAL INVESTIGATOR

• Cris Molas, Msc

  Associació Disminuïts Físics d'Osona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gil Serrancolí, PhD

CONTACT

+34620372629; gil.serrancoli@upc.edu

Cris Molas, Msc

CONTACT

muvity.rehab@adfo.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Both groups are assessed by a blinded physiotherapist, before and after the treatments. This does not know in which group the participant is involved.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: April 30, 2024
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)