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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Standard Home Exercise Program | Active comparator | Not described Receives: Behavioral: Standard Home Exercise Program |
| Web-based Home Exercise Program | Experimental | Not 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.
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)
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
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
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
Amount of Practice
time completing home exercises
Measured: Measured throughout training
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.
- First posted30 Mar 2018
- Study start1 Sep 2019
- Primary completion22 Jun 2022
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Principal investigator, Kelly Westlake, University of Maryland, Baltimore
- Investigators
- Kelly A Westlake, PhD, PT, Principal investigator, University of MarylandJill Whitall, PhD, Study director, University of Maryland
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Interactive Web-Based Home Therapy Program in the Recovery of Arm and Hand Function Following Stroke: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03484182
- Acronym / sponsor ID
- STRONG / HP-00077863
- Conditions
- Stroke
- Keywords
- Upper extremity, Stroke, Web-based program, Home exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Home Exercise Program | Active comparator | Behavioral: Standard Home Exercise Program |
| Web-based Home Exercise Program | Experimental | Behavioral: Web-based Home Exercise Program |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Home Exercise ProgramHome exercises that are guided by a web-based program | Behavioural | Web-based Home Exercise Program |
| Standard Home Exercise ProgramStandard paper-based home exercise program | Behavioural | Standard Home Exercise Program |
Primary outcome
Wolf Motor Function Test Short Battery
Time frame: Change after 6 weeks training and 4.5 months after training
Upper extremity function measure- 6 timed tasks - Up to 2 mins per task permitted. Shorter time indicates better outcome
5 secondary outcomes
Fugl Meyer Upper Extremity Motor Performance
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks of training
Stroke Self-Efficacy Questionnaire
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks of training
Stroke Rehabilitation Motivation Scale
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks of training
Amount of Practice
Time frame: Measured throughout training
Motor Activity Log
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 40996050Westlake 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly A Westlake, PhD, PT principal investigator
University of Maryland
Jill Whitall, PhD study director
University of Maryland
1 site in 1 country: see every site and its status.
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.