StrokeNCT01574599
Use of Repetitive Facilitative Exercise Program in Established Stroke
A study testing Occupational therapy- Repetitive Facilitative Exercise in people with Stroke, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Occupational therapy- Repetitive Facilitative Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
- The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
- Capable of effectively participating in the study
Who cannot join
- Upper extremity contracture/pain that interfere with study technique
- Pre-existing upper extremity neurologic or orthopedic disorders
- Unstable medical condition
- BMI > 35
- Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
- Language or cognitive/perceptual deficits or scheduling problems that would limit participation
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment
The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.
- Conditions
- Stroke
- Being tested
- Occupational therapy- Repetitive Facilitative Exercise
- Keywords
- Stroke, weakness, rehabilitation, chronic stroke
- Medical subject headings
- Stroke, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapy- Repetitive Facilitative ExerciseOther
Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Facilitative Exercise | Experimental | Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks. Receives: Other: Occupational therapy- Repetitive Facilitative Exercise |
| Conventional Therapy Program | No intervention | Typical therapy excluding robotics, RFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Arm score
Measured: baseline, immediate post-intervention and 3 month post-intervention
Secondary outcomes (6)
Motor Activity Log
Measured: baseline, immediate post-intervention and 3 month post-intervention
9-Hole Peg Test
Measured: baseline, immediate post-intervention and 3 month post-intervention
Box and Block test
Measured: baseline, immediate post-intervention and 3 month post-intervention
Grasp strength
Measured: baseline, immediate post-intervention and 3 month post-intervention
Active Range of motion of shoulder flexion, wrist extension, and index finger extension
Measured: baseline, immediate post-intervention and 3 month post-intervention
Overall patient satisfaction
Measured: baseline, immediate post-intervention and 3 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: poor subject recruitment
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 Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Billie A. Schultz, Mayo Clinic
- Investigators
- Billie Schultz, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574599
- Sponsor's protocol ID
- 11-005596
- Status last verified
- Mar 2017
- First submitted
- 6 Apr 2012
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Evaluation of a Repetitive Facilitative Exercise Program for Adults With an Established Stroke and Upper Extremity Impairment
- ClinicalTrials.gov ID
- NCT01574599
- Acronym / sponsor ID
- 11-005596
- Conditions
- Stroke
- Keywords
- Stroke, weakness, rehabilitation, chronic stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor subject recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Apr 2012 (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.
The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive Facilitative Exercise | Experimental | Other: Occupational therapy- Repetitive Facilitative ExerciseOccupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks. |
| Conventional Therapy Program | No intervention | –Typical therapy excluding robotics, RFE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years
- Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
- The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
- Capable of effectively participating in the study
Key exclusion criteria (7 listed)
- Upper extremity contracture/pain that interfere with study technique
- Pre-existing upper extremity neurologic or orthopedic disorders
- Unstable medical condition
- BMI > 35
- Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
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 |
|---|---|---|
| Occupational therapy- Repetitive Facilitative ExerciseOccupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks. | Other | Repetitive Facilitative Exercise |
Primary outcome
Fugl-Meyer Arm score
Time frame: baseline, immediate post-intervention and 3 month post-intervention
6 secondary outcomes
Motor Activity Log
Time frame: baseline, immediate post-intervention and 3 month post-intervention
9-Hole Peg Test
Time frame: baseline, immediate post-intervention and 3 month post-intervention
Box and Block test
Time frame: baseline, immediate post-intervention and 3 month post-intervention
Grasp strength
Time frame: baseline, immediate post-intervention and 3 month post-intervention
Active Range of motion of shoulder flexion, wrist extension, and index finger extension
Time frame: baseline, immediate post-intervention and 3 month post-intervention
Overall patient satisfaction
Time frame: baseline, immediate post-intervention and 3 month post-intervention
Results and safety
The study was stopped early (reason given: poor subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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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.
Billie Schultz, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy- Repetitive Facilitative Exercise in people with Stroke, run by Mayo Clinic 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 7 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 22 Mar 2017. 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 was stopped early (reason given: poor subject recruitment). 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?
Fugl-Meyer Arm score (time frame: baseline, immediate post-intervention and 3 month post-intervention). 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 22 Mar 2017.