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StrokeSTRONGNCT03484182

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

A study testing Web-based Home Exercise Program and Standard Home Exercise Program in people with Stroke, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Web-based Home Exercise Program and Standard Home Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
1 Sep 2019to 23 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • niversity of Maryland Rehabilitation and Orthopedics Institute

    Baltimore, Maryland, 21207

Other trials in United States

About this study

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

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.

Read the detailed description

Objective 1, Development of the expanded STROKE web program applicable to individuals with stroke in the USA.

This is a necessary objective to achieve before the investigators can start the trial; but it has no associated hypothesis. One rationale is to expand the target population in terms of impairment severity based both on feedback from therapists and on the need to add more bilateral activities that are important for everyday use. The second rationale is to check that material is readable and applicable to individuals with stroke in the USA.

Objective 2: To determine the immediate and durable motor function changes from a six-week web-based stroke rehab program vs. usual written exercise care in individuals discharged from outpatient therapy after a stroke.

H1: Six weeks of web-based stroke training compared to six weeks of a written home upper limb exercise program will result in clinically meaningful and statistically significant improvement in upper extremity function immediately after the intervention and 12 weeks later.

This primary hypothesis is justified based on the combination of two theoretical constructs as described earlier. First, there is evidence that web-based programs, based on Self Determination Theory principles, will show an increase in motivation to exercise vs. a control with no intervention in non-disabled individuals. Second, since the web-based program is also based on neuroplasticity and motor learning principles known to improve functional recovery, and not just physiological improvements, the participants should also improve their functional recovery rather than merely gain physical activity benefits while maintaining or even losing their functional level. Third, the pilot feasibility study supports this hypothesis for the immediate effect and, after the power analysis, for the follow up testing.

Objective 3: To determine the immediate and durable behavioral benefits of a six-week web-based stroke program vs. standard care in individuals discharged from outpatient therapy after a stroke.

H2: Six weeks of web-based stroke training compared to six weeks of a written home upper limb exercise program will result in statistically significant gains in motivation to exercise, self-efficacy and amount of practice time immediately after the intervention and 12 weeks later.

This secondary hypothesis explores whether the STRONG program will improve the patients motivation to exercise and their self-efficacy, while the written exercise program has the opposite effect, by the end of the intervention. There is evidence from the non-disabled population that behavioral improvements such as increasing exercise time will occur when individuals are intrinsically motivated but this has not been shown in the stroke population using a LifeGuide platform web-based system. Conceptually, the investigators predict that individuals with stroke will also become intrinsically motivated, because the program incorporates design details that enhance feelings of autonomy, competence and relatedness. Therefore, based on SDT, participants will not only have a better functional level but an increase in self-efficacy, motivation and independence. Specifically, during the 12 weeks after training, participants in the STRONG web program will demonstrate this by maintaining an increased amount of practice even though the investigators will have withdrawn our external support from the therapist (but not the participants ability to communicate with friends).

Embedded Qualitative Component. Qualitative work is based on inductive reasoning and is hypothesis generating rather than hypothesis testing. Therefore, the investigators do not offer specific hypotheses but outline some of the questions that will be asked to give meaning and a context to the use of the web-based program.

Objective 4: To determine the perceptions of patients/caregivers to the use of a web-based stroke training program.

Qualitative methods will be used to explore patient and caregiver experiences and perceptions of using the Web-based system as part of stroke recovery to answer questions such as - In what ways did the STRONG web program help or hinder their rehabilitation? What did participants like and dislike about it? How did participants use it and why? What difficulties did participants have with using it? How could it be better? What did participants perceive to be the 'added value' of using the STRONG web program over routine practice alone?

Objective 5: To determine the perceptions of therapists to the use of a web-based stroke training program.

Qualitative methods will be used to explore therapists' experiences and perceptions of the STRONG web program in order to answer questions such as - What are the most important/useful aspects of the STRONG web program. What are the most difficult/problematic aspects of the STRONG? When would therapists use it and why? Who is it most successful for and why? What does it add to routine practice? In what ways does it detract from or complicate routine practice?

Conditions
Stroke
Being tested
Web-based Home Exercise Program, Standard Home Exercise Program
Keywords
Upper extremity, Stroke, Web-based program, Home exercise training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-based Home Exercise ProgramBehavioural

    Home exercises that are guided by a web-based program

  • Standard Home Exercise ProgramBehavioural

    Standard paper-based home exercise program

Study groups in NCT03484182
Study groupRoleWhat they receive
Standard Home Exercise ProgramActive comparatorNot described
Receives: Behavioral: Standard Home Exercise Program
Web-based Home Exercise ProgramExperimentalNot described
Receives: Behavioral: Web-based Home Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change after 6 weeks training and 4.5 months after training

Secondary outcomes (5)
  1. Fugl Meyer Upper Extremity Motor Performance

    Upper extremity impairment measure- 0- 66 higher score indicates better outcome

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

  2. Stroke Self-Efficacy Questionnaire

    Questionnaire for self-efficacy 13 items rated on 0-10 Likert scale - higher score better

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

  3. Stroke Rehabilitation Motivation Scale

    Motivational Questionnaire - 28 item scale higher scores indicated higher levels of motivation - 7 sets of questions rated on a 5 point Likert scale with 1 completely disagree and 5 completely agree - range 7 - 35

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

  4. Amount of Practice

    time completing home exercises

    Measured: Measured throughout training

  5. Motor Activity Log

    Consisting of two questionnaires: Amount of use and quality of movement while doing functional tasks

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start1 Sep 2019
  3. Primary completion22 Jun 2022
  4. Study completion23 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484182
Sponsor's protocol ID
HP-00077863
Acronym
STRONG
Status last verified
Sep 2024
First submitted
15 Feb 2018
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40996050

Questions about this trial

What is this clinical trial studying?

A study testing Web-based Home Exercise Program and Standard Home Exercise Program in people with Stroke, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wolf Motor Function Test Short Battery (time frame: Change after 6 weeks training and 4.5 months after training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03484182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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STRONG Clinical Trial NCT03484182 | AzTrials