NCT03484182

Brief Summary

This is an online study that involves assessment and training of arm function at home. Stroke is the leading cause of disability worldwide. Of the annual incidence of stroke (\~750,000) in the USA about 60% fail to recover arm and hand use contributing to reduced quality of life for survivors and caregivers. How can therapists facilitate the rehabilitation of individuals with arm movement deficits and increase their quality of life over a long time period? It is known that principles of treatment including repetition, feedback, challenge and progression are important for producing recovery. The ability for patients to train at home and manage their own rehabilitation duration, intensity and progression, via effective self-management strategies, is vital. What is needed is an effective, easy to use, low cost system that self-motivates patients to intensively practice their therapy exercises at home while maintaining elements of repetition, feedback, challenge and progression. In this proposal the investigators intend to adapt just such a "web-based system" originally designed in the UK. The first version of the system has shown preliminary efficacy and feasibility in a small pilot study in UK. The investigators will adapt the system for use in the USA, with the assistance of consultants from the UK. The purpose of this study is to investigate the efficacy and feasibility of using a free, easy to use, interactive web-based upper extremity stroke rehab program on individuals with stroke who have been discharged from outpatient rehabilitation. The goal is to compare the home use of the web-based stroke rehab program with that of written exercises in a randomized controlled trial. The aims/objectives are to (1) adapt the existing system for use in America including adding bilateral activities and then to assess (2) motor function immediately before and after six weeks intervention and after 12 weeks follow up in order to support the efficacy of using this web-based intervention; (3) behavioral changes in motivation and self-efficacy at the same time points to understand the relationship between behavioral and motor function changes; (4) perceptions of patients and caregivers of the web-based program to understand feasibility and barriers to home use; and (5) perceptions of therapists to understand feasibility and barriers to clinic use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2019

Longer than P75 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

First Submitted

Initial submission to the registry

February 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

February 15, 2018

Last Update Submit

September 23, 2024

Conditions

Stroke

Keywords

Upper extremityStrokeWeb-based programHome exercise training

Outcome Measures

Primary Outcomes (1)

  • Wolf Motor Function Test Short Battery

    Upper extremity function measure- 6 timed tasks - Up to 2 mins per task permitted. Shorter time indicates better outcome

    Change after 6 weeks training and 4.5 months after training

Secondary Outcomes (5)

  • Fugl Meyer Upper Extremity Motor Performance

    Measured at baseline, after 6 weeks, and after 12 weeks of training

  • Stroke Self-Efficacy Questionnaire

    Measured at baseline, after 6 weeks, and after 12 weeks of training

  • Stroke Rehabilitation Motivation Scale

    Measured at baseline, after 6 weeks, and after 12 weeks of training

  • Amount of Practice

    Measured throughout training

  • Motor Activity Log

    Measured at baseline, after 6 weeks, and after 12 weeks of training

Other Outcomes (1)

  • Qualitative comments on impressions of exercise from those in Experimental Group

    Measured after 6 weeks of training

Study Arms (2)

Standard Home Exercise Program

ACTIVE COMPARATOR
Behavioral: Standard Home Exercise Program

Web-based Home Exercise Program

EXPERIMENTAL
Behavioral: Web-based Home Exercise Program

Interventions

Web-based Home Exercise ProgramBEHAVIORAL

Home exercises that are guided by a web-based program

Web-based Home Exercise Program
Standard Home Exercise ProgramBEHAVIORAL

Standard paper-based home exercise program

Standard Home Exercise Program

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals over 30 years who have Ischemic or Hemorrhagic stroke:
  • Discharged from outpatient rehabilitation
  • Impaired upper limb function: Participants must have recognizable (observable) dysfunction. They should also have the ability to move their hand forward by at least 3 inches without trunk compensation and demonstrating anti-gravity movement.
  • Must have a computer or tablet with internet access and also capability of video recording the study participant.
  • Able to provide informed consent.
  • Participants needs to have enough cognitive and communication function to understand instructions from the web-based program.

You may not qualify if:

  • Co-morbidities such as neurological, orthopaedic and cardiovascular complications that compromise safety and participation
  • Severe cognitive and communication problems indicated by failure to respond to two-step commands: Participants must be able to interact with the web-based intervention.
  • Indications of a cerebellar stroke as detected by the screening of impaired upper limb function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

niversity of Maryland Rehabilitation and Orthopedics Institute

Baltimore, Maryland, 21207, United States

Location

Related Publications (1)

  • Westlake KP, McCombe Waller S, Magder L, Akinsolotu R, Udo J, Burridge J, Whitall J. Rehabilitation Your Way: A Randomized Trial Comparing 2 Home-Based and Self-Managed Programs After Stroke. J Am Heart Assoc. 2025 Oct 7;14(19):e041433. doi: 10.1161/JAHA.125.041433. Epub 2025 Sep 25.

    PMID: 40996050DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kelly A Westlake, PhD, PT

    University of Maryland

    PRINCIPAL INVESTIGATOR

  • Jill Whitall, PhD

    University of Maryland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 30, 2018

Study Start

September 1, 2019

Primary Completion

June 22, 2022

Study Completion

September 23, 2024

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)