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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.

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

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.

United States1 site
  • VAMC, Palo Alto

    Palo Alto, California

Other trials in United States

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.

  1. First posted16 Mar 2001 (estimated)
  2. Study startJul 1999
  3. Study completionJun 2003

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 2
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Enrolment
30 participants
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

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.

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