Virtually Assisted Home Rehabilitation After Acute Stroke-2

Stroke Clinical Trial

— (VAST-rehab2)  

Official title:

Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737524
• Other study ID #: HSC-MS-22-1005
• Status: Completed
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: January 26, 2024

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Telerehabilitation (VAST 2)
The telehealth platform will be available by a web secure link accessible on a home computer or loaded on user friendly tablets that are customized for the patient's impairments. Telerehabilitation services will include 2 out of 3 disciplines: Occupational Therapy, Speech Therapy, Physical Therapy. All therapy interventions will be delivered by licensed therapists and will be based on patients' specific impairments and goals. Therapy intervention will be provided 3x/wk. for each of 2 disciplines. The intervention will be going on for 4 weeks which will total to 24 sessions. Self-management support with trained health coach will be integrated into 1 therapy session each week. An additional individual 30 minute session will occur with the health coach each week.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Lone Star Stroke Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The experience of the participant measured by the participant experience surveys		end of study (about 10 weeks after baseline)
Primary	Number of participants that completed all scheduled visits.		end of study (about 10 weeks after baseline)
Secondary	Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)	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	Baseline, end of intervention (about 5 weeks after baseline)
Secondary	Change in quality of life as assessed by the Short Form (SF-12)health questionnaire	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	Baseline, end of intervention (about 5 weeks after baseline)
Secondary	Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.	Baseline, end of intervention (about 5 weeks after baseline)
Secondary	Change in depression as assessed by the Patient Health Questionnaire (PHQ8)	This is an 8 item questionnaire and each is scored from 0-24 a higher number indicating more depression	Baseline, end of intervention (about 5 weeks after baseline)
Secondary	Change in disability as assessed by the Modified Rankin Scale (mRS)	This scale is scored from 0(no symptoms at all) to 6 (dead), with a higher score being the worst outcome	Baseline, end of intervention (about 5 weeks after baseline)
Secondary	Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	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	week 2
Secondary	Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	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	week 3
Secondary	Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	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	week 4
Secondary	Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	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	week 5
Secondary	Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	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	week 10
Secondary	Type of technology used by stroke patients as assessed by a questionnaire	Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.	end of intervention (about 5 weeks after baseline)
Secondary	Type of internet access used by stroke patients as assessed by a questionnaire	Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband	end of intervention (about 5 weeks after baseline)
Secondary	Use of computer equipment by stroke patients as assessed by a questionnaire	Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones	end of intervention (about 5 weeks after baseline)
Secondary	Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire	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	end of intervention (about 5 weeks after baseline)
Secondary	Number of stroke patients who exhibited any issues when they use the telehealth platform		end of intervention (about 5 weeks after baseline)
Secondary	Type of technology used by caregivers as assessed by a questionnaire	Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.	end of intervention (about 5 weeks after baseline)
Secondary	Type of internet access used by caregivers as assessed by a questionnaire	Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband	end of intervention (about 5 weeks after baseline)
Secondary	Use of computer equipment by caregivers as assessed by a questionnaire	Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones	end of intervention (about 5 weeks after baseline)
Secondary	Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire	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	end of intervention (about 5 weeks after baseline)
Secondary	Number of caregivers who exhibited any issues when they use the telehealth platform		end of intervention (about 5 weeks after baseline)
Secondary	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)
Secondary	Number of patients living in underserved areas		Baseline
Secondary	Number of patients living in under resourced neighborhoods		Baseline
Secondary	Socio Economic Status (SES) of patients as assessed by the patient demographics		Baseline
Secondary	Housing condition of patients as assessed by the patient demographics		Baseline
Secondary	Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 2
Secondary	Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 3
Secondary	Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 4
Secondary	Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 5
Secondary	Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 2
Secondary	Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 3
Secondary	Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 4
Secondary	Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 5