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

Stroke Clinical Trial

— TELEICTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05703906
• Other study ID #: 2017.16
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Telerehabilitation - VRRS Khymeia
Participants will receive an individualized, multidomain exercise program set up by the therapist, based on their needs. The intervention applied will consist of 20 sessions of motor, language and/or cognitive training distributed in five sessions for week, each lasting 1 hour. Remotely, the therapist will supervise the participant's exercise program.

Locations

Country	Name	City	State
Italy	IRCCS San Camillo Hospital	Venice

Sponsors (6)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy	Fondazione Don Carlo Gnocchi Onlus, IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), IRCCS Fondazione Istituto Neurologico Casimiro Mondino, Pavia (IT), IRCCS San Raffaele Roma, Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Cacciante L, Kiper P, Garzon M, Baldan F, Federico S, Turolla A, Agostini M. Telerehabilitation for people with aphasia: A systematic review and meta-analysis. J Commun Disord. 2021 Jul-Aug;92:106111. doi: 10.1016/j.jcomdis.2021.106111. Epub 2021 May 13. — View Citation

Cacciante L, Pieta CD, Rutkowski S, Cieslik B, Szczepanska-Gieracha J, Agostini M, Kiper P. Cognitive telerehabilitation in neurological patients: systematic review and meta-analysis. Neurol Sci. 2022 Feb;43(2):847-862. doi: 10.1007/s10072-021-05770-6. Epub 2021 Nov 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of telerehabilitation system	Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).	6 weeks
Primary	Feasibility of telerehabilitation system	Feasibility will be measured with the Technology Acceptance Model (TAM), a specific questionnaire used to quantify the likelihood of technology acceptance, consisting of 12 items, six assessing perceived usefulness and six assessing perceived ease of use.	6 weeks
Primary	Feasibility of telerehabilitation system	Feasibility will be measured with the System Usability Questionnaire (SUS), a 10 item questionnaire with five response options: from Strongly agree to Strongly disagree.	6 weeks
Secondary	Change in measure of quality of life	Quality of life will be measured by the Short-Form-36 Health Survey (SF-36), a questionnaire comprising 36 questions that cover 8 domains of health. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each domain. Each domain can be used independently.	Baseline up to 6 weeks
Secondary	Change in measure of quality of life	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).	Baseline up to 6 weeks
Secondary	Change in motor functions	Change in motor functions will be assessed with the Fugl-Meyer Assessment (FMA), a stroke-specific scale which assesses the motor functioning in patients with post-stroke. There are 3 values for each of the 5 domain: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The 5 domains assessed include: motor function (upper limb maximum score = 66; lower limb maximum score = 34), sensory function (maximum score = 24), balance (maximum score = 14), joint range of motion (maximum score = 44), joint pain (maximum score = 44), for an overall maximum score of 226 points.	Baseline up to 6 weeks
Secondary	Change in motor functions	Assessed with the Nine hole pegboard test (NHPT), to measure finger dexterity. It is administered by asking the participant to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Scores are based on the time taken to complete the activity, recorded in seconds.	Baseline up to 6 weeks
Secondary	Change in motor functions	Assessed with the Box and block test (BBT). The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.	Baseline up to 6 weeks
Secondary	Change in motor functions	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).	Baseline up to 6 weeks
Secondary	Change in linguistic functions	Aachen Aphasie Test (AAT)	Baseline up to 6 weeks
Secondary	Change in cognitive functions	Assessed with the Montreal Cognitive Assessment (MoCA), a cognitive screening tool comprising 16 items and 11 categories to assess multiple cognitive domains. The total possible score is 30, corresponding to a good performance.	Baseline up to 6 weeks
Secondary	Change in cognitive functions	Assessed with the Bells test, a cancellation test that allows for a quantitative and qualitative assessment of visual neglect in the near extra personal space. The total number of cancelled bells is recorded as well as the time taken to complete. The maximum score is 35.	Baseline up to 6 weeks
Secondary	Change in cognitive functions	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.	Baseline up to 6 weeks
Secondary	Change in Independence (Activities of Daily Living)	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).	Baseline up to 6 weeks
Secondary	Change in behavior (depression)	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.	Baseline up to 6 weeks
Secondary	Change in caregiver burden	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.	Baseline up to 6 weeks
Secondary	Satisfaction of the treatment	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.	6 weeks