Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab)

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Telerehabilitation

• Registration Number: NCT05659784
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-21
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	Telerehabilitation	-

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by number of participants that completed all scheduled visits.	end of study(12 weeks form baseline)

Secondary Outcome Measures

Name	Time	Method
Change in Functional independence as assessed by the Functional Independence Measure (FIM)	Baseline, end of study (about 13-14 weeks after baseline)	This is an 18 item questionnaire and each is scored from 1(complete dependence on helper) to 7(complete independence), a higher number indicating more independence
Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)	Baseline, end of study (about 13-14 weeks after baseline)	8 item questionnaire ,with a possible score of 1-5, a lower number indicating higher cognitive impairment
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)	Baseline, end of study (about 13-14 weeks after baseline)	This is a A 59 item questionnaire whereby subjects identify the impact of stroke 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 quality of life as assessed by the EuroQol-5-5level scale (EQ-5D-5L)	Baseline, end of study (about 13-14 weeks after baseline)	A self reporting, quality of life measurement that asks Subjects to rate their severity of problems related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 5 questions in the first section and each question is scored from 0-5,a higher number indicating a worse outcome .There is a visual scale at the end that is scored from 0(worst health) to 100(best health), higher number indicating better outcome .; .
Patient-Specific Functional Scale	Baseline, end of study (about 13-14 weeks after baseline)	This tool allows for Subjects to self report activities of daily living that have been affected by stroke and rate severity of impact on these activities. This is scored from 0(unable to perform activity) to 10(able to perform activity at the same level as before injury or problem)
Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)	Baseline, end of study (about 13-14 weeks after baseline)	the score for each ability is a number between 0(normal functioning) to 4(completely impaired). The score is calculated by adding the number for each element of the scale with a highest score of 42, a higher score meaning more impairment.
Change in degree of disability or dependence as measured by the Modified Rankin Score(mRS)	Baseline, end of study (about 13-14 weeks after baseline)	mRS is a 6 point disability scale with possible scores from 0(no disability) to 5(disability requiring constant care) a higher score indicating more disability
Change in performance in activities of daily living as assessed by the Barthel Index	Baseline, end of study (about 13-14 weeks after baseline)	This is a scoring technique that measures performance in ten activities of daily living including feeding, wheelchair to bed transfers, grooming ,chair to toilet transfers, walking, using stairs, dressing, and continence of bowels and bladder. This is a 10 item questionnaire and is scored from 0-100, a higher score indicating higher level of independence.

Trial Locations

Locations (1)

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