Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Telerehabilitation - VRRS Khymeia

• Registration Number: NCT05703906
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

Brief Summary

The main aim of this longitudinal, pilot study is to evaluate the feasibility of a multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using the Virtual Reality Rehabilitation System (VRRS, Khymeia) in patients with stroke. Furthermore, data on patients' needs and clinical data will be collected before and after treatment and then analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Single ischemic stroke documented by CT/ MRI;
• 2 to 18 months after the event.

Exclusion Criteria

• medical history or presence of cognitive decline (MoCA<17.54)
• recent fractures
• History of mental disorders (major depression, psychosis)
• History/presence of other neurological disorders that may interfere with outcome
• Presence of other internal pathologies that may interfere with outcome or treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	Telerehabilitation - VRRS Khymeia	All patients will receive a kit home-based consisting of a tablet home, an exercise equipment and access to a daily individualized training program based on their needs (i.e., motor, language and/or cognitive training programs). The exercise program and patients' sessions will be remotely supervised by therapists.

Primary Outcome Measures

Name	Time	Method
Feasibility of telerehabilitation system	6 weeks	Feasibility will be measured with the System Usability Questionnaire (SUS), a 10 item questionnaire with five response options: from Strongly agree to Strongly disagree.

Secondary Outcome Measures

Name	Time	Method
Change in motor functions	Baseline up to 6 weeks	Assessed with the Ashworth Spasticity Scale. The therapist evaluates the spasticity of the muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Change in caregiver burden	Baseline up to 6 weeks	Assessed with the Zarit Burden Interview (ZBI). It comprises 22 items with a score ranging from 0 ("never" to 4 ("nearly always"). Total scores are obrained by summing all items endorsed.
Change in cognitive functions	Baseline up to 6 weeks	Assessed with the verbal fluency test. Participants have to produce as many words as possible from a semantic and a phonemic category in 1 minute.
Change in Independence (Activities of Daily Living)	Baseline up to 6 weeks	Assessed with the Barthel Index (BI). It comprises 10 ADL/mobility activities, items are rated based on the amount of assistance required to complete each activity. Each item score ranges from 0 (dependent) to 10 (independent).
Satisfaction of the treatment	6 weeks	Client Satisfaction Questionnaire, it consists of a 6 item questionnaire with five response options: from 0 to 4, where 0 reflects a negative response and 4 reflects a positive response.
Change in measure of quality of life	Baseline up to 6 weeks	Quality of life will be measured by the EuroQol-5 dimensions (EQ-5D), a questionnaire measuring 5 dimensions described by 3 possible levels of problems (i.e., none, mild-to-moderate, severe). Respondent's answers are translated into a preference-based score, yielding an index score based on a scale from 0.000 (death) to 1.000 (perfect health). The 5 dimensions can be converted to a single utility value (EQ-Index score).
Change in linguistic functions	Baseline up to 6 weeks	Aachen Aphasie Test (AAT)
Change in behavior (depression)	Baseline up to 6 weeks	Assessed with the Beck Depression Inventory (BDI). Items are on a four-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0-63. Scores \>10 generally meet the threshold for a diagnosis of depression.

Trial Locations

Locations (1)

IRCCS San Camillo Hospital; 🇮🇹 Venice, Italy