Muscle SpasticityNCT00893776
Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis
A study testing Task Training in people with Muscle Spasticity, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
A small, pilot study consisting of twelve participants with subacute (6-12 months post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The twelve participants will randomly be selected to participate in either unilateral (one-handed) task training (6 participants) or bilateral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- Task Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- >6 months post stroke
- diagnosis of first stroke
- medically stable
- ability to follow multipart verbal directions
- score of >26 on Mini-Mental Status Exam
Show all 12Show fewer
- achieve 10 degrees elbow flexion
- 1/4 range volitional finger flexion when hand positioned in wrist and finger extension
- capable of standing for >2 minutes without an assistive ambulatory device
- maintain independence in self-care or have a caretaker to provide assistance
- no concurrent skilled therapy treatment
- not participating in any experimental rehabilitation or drug studies.
Who cannot join
- more than one stroke/multiple strokes
- receptive aphasia
- medically documented dementia
- score less than 26 on Mini Mental Status Exam
- contractures or joint deformities in the affected hand or wrist that impede the ability to use the device
- inability to transfer 12 balls crate right and 12 balls crate left, while using the Saeboflex device on the affected arm, by the end of a 5-day training session.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri, Lewis and Clark Hall
Columbia, Missouri, 65211
About this study
Official title: The Effectiveness of Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis in Individuals With Subacute and Chronic Stroke.
A small, pilot study consisting of twelve participants with subacute (6-12 months post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The twelve participants will randomly be selected to participate in either unilateral (one-handed) task training (6 participants) or bilateral (two-handed) task training (6 participants) with the SaeboFlex orthosis. Each group will undergo six assessments to establish pre-testing baseline and qualification, followed by a training session, four-week combined home and clinic program, and post-testing to determine changes in affected arm use and function. The hypothesis is that two-handed training will before effective than one-handed training.
Read the detailed description
The SaeboFlex device is a mechanical orthosis that promotes grasp and release and functional movement of an upper limb that has impaired movement due to a stroke. Many researchers have found that incorporating both the affected and unaffected limb together during exercises (bilateral task training) results in increased functional use of the affected limb as compared to only performing exercises with the affected limb. Therefore, we want to determine if bilateral task training is more effective than unilateral task training with the use of the SaeboFlex device in subacute and chronic stroke rehabilitation. For the unilateral training group, exercises will be completed with only the affected hand using the Saebo device. For the bilateral group, the Saebo will be on the affected hand, no device on the unaffected hand, and both arms will do the exact same movements/exercises at the same time. The participants will be videotaped and photographed moving balls without the device, with the device at the start of the study, with the device midway through the study, and at the end of the study. This will be done for the purpose of providing participant feedback regarding their progress and for report of outcomes upon completion of the project. Faces will be omitted from all photographic media at the request of the participant, and the participant may decline photographic media at any time without having to withdraw from the study.
- Conditions
- Muscle Spasticity
- Being tested
- Task Training
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task TrainingOther
Task training is the movement of balls in an individually prescribed fashion using the SaeboFlex orthosis on the affected extremity.
| Study group | Role | What they receive |
|---|---|---|
| 1 Unilateral Group | Active comparator | This group will wear the SaeboFlex orthosis on their affected extremity and do exercises with that extremity only. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns) Receives: Other: Task Training |
| 2 Bilateral training | Experimental | Members of this group will wear the SaeboFlex orthosis on the affected extremity and do exercises with the affected extremity and the non-affected extremity at the same time. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns) Receives: Other: Task Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test (WMFT)
Measured: Before and immediately after intervention
Secondary outcomes (1)
Canadian Occupational Performance Measure
Measured: Before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Insufficient time for study extenuating personal circumstances of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulianne Krug, MA, OTR/L, Principal investigator, University of Missouri, Occupational Therapy and Occupational Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893776
- Sponsor's protocol ID
- 1134397
- Status last verified
- Oct 2017
- First submitted
- 4 May 2009
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Bilateral Versus Unilateral Task Retraining Using the SaeboFlex Orthosis in Individuals With Subacute and Chronic Stroke.
- ClinicalTrials.gov ID
- NCT00893776
- Acronym / sponsor ID
- 1134397
- Conditions
- Muscle Spasticity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient time for study extenuating personal circumstances of PI
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 May 2009 (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.
A small, pilot study consisting of twelve participants with subacute (6-12 months post-stroke)and chronic stroke (1year+ post-stroke)living in and around Columbia area. The twelve participants will randomly be selected to participate in either unilateral (one-handed) task training (6 participants) or bilateral (two-handed) task training (6 participants) with the SaeboFlex orthosis. Each group will undergo six assessments to establish pre-testing baseline and qualification, followed by a training session, four-week combined home and clinic program, and post-testing to determine changes in affected arm use and function. The hypothesis is that two-handed training will before effective than one-handed training.
Detailed description
The SaeboFlex device is a mechanical orthosis that promotes grasp and release and functional movement of an upper limb that has impaired movement due to a stroke. Many researchers have found that incorporating both the affected and unaffected limb together during exercises (bilateral task training) results in increased functional use of the affected limb as compared to only performing exercises with the affected limb. Therefore, we want to determine if bilateral task training is more effective than unilateral task training with the use of the SaeboFlex device in subacute and chronic stroke rehabilitation. For the unilateral training group, exercises will be completed with only the affected hand using the Saebo device. For the bilateral group, the Saebo will be on the affected hand, no device on the unaffected hand, and both arms will do the exact same movements/exercises at the same time. The participants will be videotaped and photographed moving balls without the device, with the device at the start of the study, with the device midway through the study, and at the end of the study. This will be done for the purpose of providing participant feedback regarding their progress and for report of outcomes upon completion of the project. Faces will be omitted from all photographic media at the request of the participant, and the participant may decline photographic media at any time without having to withdraw from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Unilateral Group | Active comparator | Other: Task TrainingThis group will wear the SaeboFlex orthosis on their affected extremity and do exercises with that extremity only. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns) |
| 2 Bilateral training | Experimental | Other: Task TrainingMembers of this group will wear the SaeboFlex orthosis on the affected extremity and do exercises with the affected extremity and the non-affected extremity at the same time. SaeboFlex exercises include moving the ball in high repetition of grasp and release while wearing the SaeboFlex orthosis to various positions individualized to each participant based on movement deficits, as well as Task Training (using the affected arm during specific functional activities to use newly acquired movement patterns) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- at least 18 years of age
- >6 months post stroke
- diagnosis of first stroke
- medically stable
- ability to follow multipart verbal directions
Key exclusion criteria (6 listed)
- more than one stroke/multiple strokes
- receptive aphasia
- medically documented dementia
- score less than 26 on Mini Mental Status Exam
- contractures or joint deformities in the affected hand or wrist that impede the ability to use the device
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 |
|---|---|---|
| Task TrainingTask training is the movement of balls in an individually prescribed fashion using the SaeboFlex orthosis on the affected extremity. | Other | 1 Unilateral Group, 2 Bilateral training |
Primary outcome
Wolf Motor Function Test (WMFT)
Time frame: Before and immediately after intervention
1 secondary outcome
Canadian Occupational Performance Measure
Time frame: Before and immediately after intervention
Results and safety
The study was stopped early (reason given: Insufficient time for study extenuating personal circumstances of PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- This is the device we are using for the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Giulianne Krug, MA, OTR/L principal investigator
University of Missouri, Occupational Therapy and Occupational Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task Training in people with Muscle Spasticity, run by University of Missouri-Columbia 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 12 inclusion and 6 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 26 Oct 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: Insufficient time for study extenuating personal circumstances of PI). 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?
Wolf Motor Function Test (WMFT) (time frame: Before and immediately after 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 26 Oct 2017.