Virtually Assisted Home Rehabilitation After Acute Stroke-2

NCT05737524 | Completed

• 1 other identifier: HSC-MS-22-1005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

telerehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (33)

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

  Baseline, end of intervention (about 5 weeks after baseline)

• Change in quality of life as assessed by the Short Form (SF-12)health questionnaire

  Baseline, end of intervention (about 5 weeks after baseline)

• Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)

  Baseline, end of intervention (about 5 weeks after baseline)

• Change in depression as assessed by the Patient Health Questionnaire (PHQ8)

  Baseline, end of intervention (about 5 weeks after baseline)

• Change in disability as assessed by the Modified Rankin Scale (mRS)

  Baseline, end of intervention (about 5 weeks after baseline)

Study Arms (1)

Telerehabilitation (VAST 2)

EXPERIMENTAL

Other: Telerehabilitation (VAST 2)

Interventions

Telerehabilitation (VAST 2) OTHER

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.

Telerehabilitation (VAST 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Lone Star Stroke Consortium: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sean Savitz, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 21, 2023
• Study Start: March 9, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)