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Clinical Trials/NCT05703906
NCT05703906
Completed
N/A

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

IRCCS San Camillo, Venezia, Italy1 site in 1 country84 target enrollmentMarch 16, 2018
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
IRCCS San Camillo, Venezia, Italy
Enrollment
84
Locations
1
Primary Endpoint
Feasibility of telerehabilitation system
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 16, 2018
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
IRCCS San Camillo, Venezia, Italy
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility of telerehabilitation system

Time Frame: 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 Outcomes

  • Change in motor functions(Baseline up to 6 weeks)
  • Change in caregiver burden(Baseline up to 6 weeks)
  • Change in cognitive functions(Baseline up to 6 weeks)
  • Change in Independence (Activities of Daily Living)(Baseline up to 6 weeks)
  • Satisfaction of the treatment(6 weeks)
  • Change in measure of quality of life(Baseline up to 6 weeks)
  • Change in linguistic functions(Baseline up to 6 weeks)
  • Change in behavior (depression)(Baseline up to 6 weeks)

Study Sites (1)

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