NCT05659784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

December 12, 2022

Last Update Submit

February 22, 2024

Conditions

Stroke

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (1)

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

    end of study(12 weeks form baseline)

Secondary Outcomes (8)

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

    Baseline, end of study (about 13-14 weeks after baseline)

  • Patient-Specific Functional Scale

    Baseline, end of study (about 13-14 weeks after baseline)

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

    Baseline, end of study (about 13-14 weeks after baseline)

  • 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)

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

    Baseline, end of study (about 13-14 weeks after baseline)

  • +3 more secondary outcomes

Study Arms (1)

Telerehabilitation

EXPERIMENTAL
Other: Telerehabilitation

Interventions

TelerehabilitationOTHER

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

Telerehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Stevens EA, Muraly N, Da Silva CP, Richards L, Sosa A, Smith H, Richard AS, Manji S, Russell ME, Savitz SI. Virtually assisted home rehabilitation after acute stroke (VAST-rehab): A descriptive pilot study for young and underserved stroke survivors. Digit Health. 2025 Mar 17;11:20552076251324443. doi: 10.1177/20552076251324443. eCollection 2025 Jan-Dec.

    PMID: 40103648DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth 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

December 12, 2022

First Posted

December 21, 2022

Study Start

April 20, 2020

Primary Completion

May 8, 2023

Study Completion

May 8, 2023

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)