Virtually Assisted Home Rehabilitation After Acute STroke (VAST-rehab) - Clinical Trial for Stroke | NCT05659784

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Telerehabilitation

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telerehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Feasibility as assessed by number of participants that completed all scheduled visits.

Secondary Outcome Measures

Change in Functional independence as assessed by the Functional Independence Measure (FIM)

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

Patient-Specific Functional Scale

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 impact of stroke as assessed by the Stroke Impact Scale (SIS)

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)

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 . .

Change in cognitive impairment as assessed by the Short Montreal Cognitive Assessment(s-MoCA)

8 item questionnaire ,with a possible score of 1-5, a lower number indicating higher cognitive impairment

Change in performance in activities of daily living as assessed by the Barthel Index

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.

Change in symptoms related to stroke as assessed by the National Institute of Health Stroke Scale(NIHSS)

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)

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

Full Information

NCT ID

NCT05659784

First Posted

December 12, 2022

Last Updated

March 29, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05659784

Brief Title

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

Acronym

VAST-rehab

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telerehabilitation

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Telerehabilitation

Intervention Description

Education based telerehab with rehabilitation therapists providing education on home exercises and stroke specific information

Primary Outcome Measure Information:

Title

Feasibility as assessed by number of participants that completed all scheduled visits.

Time Frame

end of study(12 weeks form baseline)

Secondary Outcome Measure Information:

Title

Change in Functional independence as assessed by the Functional Independence Measure (FIM)

Description

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

Time Frame