Virtually Assisted Home Rehabilitation After Acute Stroke-2

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Telerehabilitation (VAST 2)

• Registration Number: NCT05737524
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to assess feasibility of a virtual rehabilitation program in stroke patients and to assess treatment effects, patient goal attainment with self-guided rehabilitation activities, barriers to and facilitators of telerehab, hospital readmission events, and social determinants of health

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Study Start: 2023-03-09
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Informed consent provided by the subject or legally authorized representative.
• Diagnosed with hemorrhagic or ischemic stroke
• Pre-stroke mRS is 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
• Mild-moderate impairments in motor or cognitive function

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telerehabilitation (VAST 2)	Telerehabilitation (VAST 2)	-

Primary Outcome Measures

Name	Time	Method
The experience of the participant measured by the participant experience surveys	end of study (about 10 weeks after baseline)
Number of participants that completed all scheduled visits.	end of study (about 10 weeks after baseline)

Secondary Outcome Measures

Name	Time	Method
Socio Economic Status (SES) of patients as assessed by the patient demographics	Baseline
Housing condition of patients as assessed by the patient demographics	Baseline
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.	week 5
Change in quality of life as assessed by the Short Form (SF-12)health questionnaire	Baseline, end of intervention (about 5 weeks after baseline)	This is a health related quality of life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Number of stroke patients who exhibited any issues when they use the telehealth platform	end of intervention (about 5 weeks after baseline)
Use of computer equipment by caregivers as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones
Use of computer equipment by stroke patients as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones
Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)	Baseline, end of intervention (about 5 weeks after baseline)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Change in disability as assessed by the Modified Rankin Scale (mRS)	Baseline, end of intervention (about 5 weeks after baseline)	This scale is scored from 0(no symptoms at all) to 6 (dead), with a higher score being the worst outcome
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	week 10	This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment
Number of patients living in underserved areas	Baseline
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.	week 5
Type of technology used by stroke patients as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.
Type of internet access used by stroke patients as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband
Type of technology used by caregivers as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.
Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)	Baseline, end of intervention (about 5 weeks after baseline)	This is a A 59 item questionnaire whereby subjects identify the impact of treatment on strength, hand function, mobility, activities of daily living, memory, communication, emotion, and handicap. Item responses are scored on a 5-point Likert-style scale. A score of 1 = an inability to complete the item and a score of 5 = no difficulty experienced at all. A standardized score ranging from 0 to 100 is calculated for all domains, with higher scores indicating a higher quality of life
Change in depression as assessed by the Patient Health Questionnaire (PHQ8)	Baseline, end of intervention (about 5 weeks after baseline)	This is an 8 item questionnaire and each is scored from 0-24 a higher number indicating more depression
Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped
Type of internet access used by caregivers as assessed by a questionnaire	end of intervention (about 5 weeks after baseline)	Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband
Number of caregivers who exhibited any issues when they use the telehealth platform	end of intervention (about 5 weeks after baseline)
Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events	end of intervention (about 5 weeks after baseline)
Number of patients living in under resourced neighborhoods	Baseline

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States