StrokePhase 2PEDALNCT01391949
Pedaling Exercises for Disability and Activity Limitations
A Phase 2 study testing Detailed feedback and Basic feedback in people with Stroke, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Detailed feedback and Basic feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2015
- 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
Who may be able to join
- diagnosis of stroke
- no major contraindications to participating in light-to-moderate exertion
- able to follow and retain verbal directions to carry out simple lower extremity repetitive exercises
- planned discharge to home with family available to assist
Who cannot join
- pre-morbid limitations in walking related to another medical disease
- body mass index >30
- fractures or contractures that prevent use of an extremity for pedaling
- impairment in cognition that precludes a full understanding of the risks and benefits of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: UCFit Pedaling Exercises to Limit Disability in the Outpatient Setting
This purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting.
Read the detailed description
The UCFit (University of California's U Cycle to Fitness) device is a standard commercial arm and leg restorator modified to collect pedaling data and to transmit it wirelessly to a central database, allowing for remote exercise monitoring. In this study, patients with stroke will perform pedaling exercise on the UCFit device prior to and then for a period of twelve weeks after discharge to home from inpatient rehabilitation. Differing levels of feedback will be provided to study subjects and corresponding changes in the amount of pedaling and walking performed will be identified. The results of this study will offer insight into the activity levels of disabled persons in their home environments. Furthermore, it will help in the identification of strategies that can increase activity levels in the critical period after discharge to home.
- Conditions
- Stroke
- Being tested
- Detailed feedback, Basic feedback
- Keywords
- disability, walking, feedback, exercise
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed feedbackBehavioural
Once a week subjects will receive feedback about the total time spent cycling and walking in the previous week. Subjects in this intervention group will also receive feedback about average cycling speed, distance pedaled, average walking speed, and distance walked in the previous week.
Basic feedbackBehavioural
Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.
| Study group | Role | What they receive |
|---|---|---|
| Detailed feedback | Experimental | Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise. Receives: Behavioral: Detailed feedback |
| Basic feedback | Active comparator | Subjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise. Receives: Behavioral: Basic feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Fastest safe walking speed over 10 meters
Measured: three months
Secondary outcomes (1)
Distance walked in 3 minutes
Distance walked at fastest safe speed over 3 minutes
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce H. Dobkin, University of California, Los Angeles
- Investigators
- Andrew Dorsch, MD, Principal investigator, University of California, Los AngelesBruce Dobkin, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391949
- Sponsor's protocol ID
- 11-001404
- Acronym
- PEDAL
- Status last verified
- May 2022
- First submitted
- 11 Jul 2011
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCFit Pedaling Exercises to Limit Disability in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT01391949
- Acronym / sponsor ID
- PEDAL / 11-001404
- Conditions
- Stroke
- Keywords
- disability, walking, feedback, exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jul 2011 (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.
This purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting.
Detailed description
The UCFit (University of California's U Cycle to Fitness) device is a standard commercial arm and leg restorator modified to collect pedaling data and to transmit it wirelessly to a central database, allowing for remote exercise monitoring. In this study, patients with stroke will perform pedaling exercise on the UCFit device prior to and then for a period of twelve weeks after discharge to home from inpatient rehabilitation. Differing levels of feedback will be provided to study subjects and corresponding changes in the amount of pedaling and walking performed will be identified. The results of this study will offer insight into the activity levels of disabled persons in their home environments. Furthermore, it will help in the identification of strategies that can increase activity levels in the critical period after discharge to home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Detailed feedback | Experimental | Behavioral: Detailed feedbackSubjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise. |
| Basic feedback | Active comparator | Behavioral: Basic feedbackSubjects will pedal on the UCFit with a goal of 30 total minutes of daily exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of stroke
- no major contraindications to participating in light-to-moderate exertion
- able to follow and retain verbal directions to carry out simple lower extremity repetitive exercises
- planned discharge to home with family available to assist
Key exclusion criteria (4 listed)
- pre-morbid limitations in walking related to another medical disease
- body mass index >30
- fractures or contractures that prevent use of an extremity for pedaling
- impairment in cognition that precludes a full understanding of the risks and benefits of this study
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 |
|---|---|---|
| Detailed feedbackOnce a week subjects will receive feedback about the total time spent cycling and walking in the previous week. Subjects in this intervention group will also receive feedback about average cycling speed, distance pedaled, average walking speed, and distance walked in the previous week. | Behavioural | Detailed feedback |
| Basic feedbackOnce a week subjects will receive feedback about total time spent cycling and walking in the previous week. | Behavioural | Basic feedback |
Primary outcome
Walking speed
Time frame: three months
Fastest safe walking speed over 10 meters
1 secondary outcome
Distance walked in 3 minutes
Time frame: three months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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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.
Andrew Dorsch, MD principal investigator
University of California, Los Angeles
Bruce Dobkin, MD principal investigator
University of California, Los Angeles
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 Detailed feedback and Basic feedback in people with Stroke, run by University of California, Los Angeles 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 May 2022. 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 was stopped early. Results are not available in the source record.
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?
Walking speed (time frame: three months). It is what the study was designed to measure, not a finding.
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 24 May 2022; AzTrials last refreshed its copy on 3 Nov 2026.