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NCT03484182Completed

Efficacy of an Interactive Web-Based Home Therapy Program After Stroke

Efficacy of an Interactive Web-Based Home Therapy Program in the Recovery of Arm and Hand Function Following Stroke: a Randomized Trial

Source: ClinicalTrials.gov · Last updated 25 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
58 (actual)
First submitted
15 Feb 2018
Start date
1 Sept 2019
Primary completion date
22 Jun 2022
Lead sponsor
University of Maryland, Baltimore
Diseases
Stroke
NCT number
NCT03484182

What you commit to

  • Study type: Interventional
  • Participants enrolled: 58
  • From 1 Sept 2019 to the primary completion date, 22 Jun 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Co-morbidities such as neurological, orthopaedic and cardiovascular complications that compromise safety and participation

Who the study is looking for

  • Inclusion:
    • 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.

Age in the registry: 30 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
niversity of Maryland Rehabilitation and Orthopedics Institute
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.