Clinical trial NCT05659784: Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)
Official title: Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the feasibility of a virtual education and virtual visit program in engaging patients with rehabilitation at home after stroke.


Eligibility criteria: Inclusion Criteria:

* Informed consent provided by the subject or legally authorized representative.
* Occurrence of a hemorrhagic or ischemic stroke
* pre-stroke mRS less than 3
* Qualifying Stroke Event must be confirmed by CT or MRI
* Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
* Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
* Able to access the internet via a personal device

Exclusion Criteria:

* . History of neurological or other disease resulting in significant functional impairment (e.g.Parkinson's disease, motor neuron disease, moderate dementia, arthritis,contractures or fixed anatomical abnormality).
* Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
* Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.

Primary outcomes:
measure: Feasibility as assessed by number of participants that completed all scheduled visits.
timeFrame: end of study(12 weeks form baseline)
Secondary outcomes:
measure: Change in Functional independence as assessed by the Functional Independence Measure (FIM)
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Patient-Specific Functional Scale
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Change in quality of life as assessed by the EuroQol-5-5level scale (EQ-5D-5L)
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Change in performance in activities of daily living as assessed by the Barthel Index
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
measure: Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)
timeFrame: Baseline, end of study (about 13-14 weeks after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sean Savitz, MD
role: PRINCIPAL_INVESTIGATOR
References: