StrokePhase 2NCT00013494
Video-Based Functional Performance and Assessment Following Stroke
A Phase 2 study testing Stroke Rehabilitation in people with Stroke, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of physical function. This project will develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the study are: (1)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke Rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jun 2003
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Hemiplegic patients
Trial locations and contacts
1 site in 1 country.
About this study
For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of physical function.
This project will develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the study are: (1) Enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.
Read the detailed description
For people who have become hemiplegic as a result of a stroke, a critical safety-related retraining area for physical functions is wheelchair transfers. In addition, to incorporate the relatively unsupervised home care into the rehabilitation process, clinicians require a better means to assess functional gains and provide effective training tools. Our goal is to develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training) which relies on the manipulation of digitized videoclips. Our development objectives are (1) to enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) to train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. Our clinical objective is to implement a 2-year evaluation of the F-PAT design concept with 30 subjects, divided in 3 groups, who as patients undergo acute rehabilitation at the VA Comprehensive Rehabilitation Center and are discharged to their homes or a sub-acute facility. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.
The study will divide the subjects into three treatment groups to compare the effectiveness of accepted practice, generic videotape, and personalized videotape home-based instruction for clients and care providers. Comparison of outcomes will be done using videotape of task performance before release from the acute therapy program and at the follow-up evaluation one month later. The subjects will be evaluated by a blinded physiatrist viewing and rating digitized videoclips of task performance on the F-PAT web site. This study will determine if personalized videoclip-based instructional material is effective, and if videoclip comparisons by a clinician is an effective diagnosis and assessment instrument. If it is not possible for logistical reasons for a subject to return to the clinic for the follow-on evaluation, the F-PAT team will visit the subject's home and perform the videotaping on-site. The remainder of the evaluation with input from the physiatrist will occur subsequently at the clinic.
- Conditions
- Stroke
- Being tested
- Stroke Rehabilitation
- Keywords
- Hemiplegia, elderly, Video, F-PAT,Functional Performance, digitized videoclips
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke RehabilitationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study startJul 1999
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- John Fryer, Ph.D., Asst. Director, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development ServiceVictoria Mongiardo, Program Analyst, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013494
- Sponsor's protocol ID
- E2169T
- Status last verified
- Mar 2006
- First submitted
- 14 Mar 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Based Functional Performance and Assessment Following Stroke
- ClinicalTrials.gov ID
- NCT00013494
- Acronym / sponsor ID
- E2169T
- Conditions
- Stroke
- Keywords
- Hemiplegia, elderly, Video, F-PAT,Functional Performance, digitized videoclips
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 1999
- Study completion
- Jun 2003 (actual)
- First posted
- 16 Mar 2001 (estimated)
- 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.
For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of physical function.
This project will develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the study are: (1) Enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.
Detailed description
For people who have become hemiplegic as a result of a stroke, a critical safety-related retraining area for physical functions is wheelchair transfers. In addition, to incorporate the relatively unsupervised home care into the rehabilitation process, clinicians require a better means to assess functional gains and provide effective training tools. Our goal is to develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training) which relies on the manipulation of digitized videoclips. Our development objectives are (1) to enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) to train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. Our clinical objective is to implement a 2-year evaluation of the F-PAT design concept with 30 subjects, divided in 3 groups, who as patients undergo acute rehabilitation at the VA Comprehensive Rehabilitation Center and are discharged to their homes or a sub-acute facility. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.
The study will divide the subjects into three treatment groups to compare the effectiveness of accepted practice, generic videotape, and personalized videotape home-based instruction for clients and care providers. Comparison of outcomes will be done using videotape of task performance before release from the acute therapy program and at the follow-up evaluation one month later. The subjects will be evaluated by a blinded physiatrist viewing and rating digitized videoclips of task performance on the F-PAT web site. This study will determine if personalized videoclip-based instructional material is effective, and if videoclip comparisons by a clinician is an effective diagnosis and assessment instrument. If it is not possible for logistical reasons for a subject to return to the clinic for the follow-on evaluation, the F-PAT team will visit the subject's home and perform the videotaping on-site. The remainder of the evaluation with input from the physiatrist will occur subsequently at the clinic.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Stroke Rehabilitation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
Related trials for Stroke
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Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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.
John Fryer, Ph.D., Asst. Director
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Victoria Mongiardo, Program Analyst
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stroke Rehabilitation in people with Stroke, run by US Department of Veterans Affairs 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?
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 21 Jan 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 21 Jan 2009.