Stroke, Upper Extremity HemiparesisNCT02277028
Bilateral Priming for Upper Extremity Hemiparesis in Older Adults
A study testing priming and task specific training in people with Stroke, Upper Extremity Hemiparesis, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Upper Extremity Hemiparesis
- What is being tested?
- priming and task specific training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have survived a unilateral stroke at least six months prior to enrollment
- Fugl Meyer Upper Extremity Score between 22-38.
Who cannot join
- No individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Comparison of Two Types of Priming for Upper Extremity Hemiparesis
This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke.
Read the detailed description
Techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. The purpose of these techniques is to prime the cortex prior to training. The priming techniques previously described in the literature include medication (i.e. amphetamines), transcranial electric or magnetic stimulation, and manipulation of somatosensory input. Here, the investigators examine a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. In this project, the investigators intend to compare bilateral upper limb priming with task specfiic training to a health care education website program followed by the same task specific training as the experimental group.This active comparator (health care education) will receive stroke related health education via a website from the American Heart Association. Transcranial Magnetic Stimulation willl include measurement of transcallosal inhibition persistence from the affected hemisphere to the less affected hemisphere and vice versa ( less affected to affected). The investigators expect the bilateral priming group to have greater changes in transcranial magnetic stimulation measures and greater improvements in behavioral measures at all time points.
- Conditions
- Stroke, Upper Extremity Hemiparesis
- Being tested
- priming and task specific training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
priming and task specific trainingBehavioural
This task specific training protocol has been used in several clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Priming | Experimental | Bilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension.
There are 2 parts to this behavioral intervention. Bilateral priming and task specific training Dosage: 15 minutes of bilateral priming per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. The total of 30 hours of a combination of bilateral priming and task specific training can be completed within 6 weeks.
Dosage frequency 2 times per day. Dosage type: Research participant must perform activities with hands as directed by an occupational therapist Receives: Behavioral: priming and task specific training |
| Health Education | Active comparator | The group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as experimental.
There are 2 parts to this behavioral intervention. Computerized health education training and task specific training Dosage: 15 minutes of health education per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. A total of 30 hours of a combination of computerized stroke health education and task specific training can be completed within 6 weeks.
Dosage frequency 2 times per day. Dosage type: Research participant must perform computerized health education activities with hands as well as task specific training directed by an occupational therapist Receives: Behavioral: priming and task specific training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)
The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance.
Measured: value at 6 weeks minus value at baseline
Secondary outcomes (1)
Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function
Change score between 2-time points (6 weeks follow up - baseline) Change score scale: minimum is 0 and maximum is 66. Higher scores indicate better outcomes.
Measured: value at 6 weeks minus value at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start1 Apr 2014
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, Upper Extremity HemiparesisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary E Stoykov, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277028
- Sponsor's protocol ID
- AOTFIRG13STOYKOV
- Status last verified
- Jan 2023
- First submitted
- 24 Oct 2014
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
King EC, Doherty M, Corcos D, Stoykov ME. Examining recruitment feasibility and related outcomes in adults post-stroke. Pilot Feasibility Stud. 2020 Oct 24;6:160. doi: 10.1186/s40814-020-00696-w. eCollection 2020.
PubMed 33110623Stoykov ME, King E, David FJ, Vatinno A, Fogg L, Corcos DM. Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study. Restor Neurol Neurosci. 2020;38(1):11-22. doi: 10.3233/RNN-190943.
PubMed 31609714
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Types of Priming for Upper Extremity Hemiparesis
- ClinicalTrials.gov ID
- NCT02277028
- Acronym / sponsor ID
- AOTFIRG13STOYKOV
- Conditions
- Stroke, Upper Extremity Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke.
Detailed description
Techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. The purpose of these techniques is to prime the cortex prior to training. The priming techniques previously described in the literature include medication (i.e. amphetamines), transcranial electric or magnetic stimulation, and manipulation of somatosensory input. Here, the investigators examine a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. In this project, the investigators intend to compare bilateral upper limb priming with task specfiic training to a health care education website program followed by the same task specific training as the experimental group.This active comparator (health care education) will receive stroke related health education via a website from the American Heart Association. Transcranial Magnetic Stimulation willl include measurement of transcallosal inhibition persistence from the affected hemisphere to the less affected hemisphere and vice versa ( less affected to affected). The investigators expect the bilateral priming group to have greater changes in transcranial magnetic stimulation measures and greater improvements in behavioral measures at all time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Priming | Experimental | Behavioral: priming and task specific trainingBilateral priming a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. There are 2 parts to this behavioral intervention. Bilateral priming and task specific training Dosage: 15 minutes of bilateral priming per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. The total of 30 hours of a combination of bilateral priming and task specific training can be completed within 6 weeks. Dosage frequency 2 times per day. Dosage type: Research participant must perform activities with hands as directed by an occupational therapist |
| Health Education | Active comparator | Behavioral: priming and task specific trainingThe group with no priming will receive stroke related health education via a website from the American Heart Association (15 minutes). They will use their affected hand (as they are able) This will be followed by 45 minutes of the same task specific arm training protocol described in the bilateral priming group. This group will follow the same schedule as experimental. There are 2 parts to this behavioral intervention. Computerized health education training and task specific training Dosage: 15 minutes of health education per day 3/days per week for 5/wks. Also 45 minutes of task specific training is delivered 3/days per week for 5/wks. A total of 30 hours of a combination of computerized stroke health education and task specific training can be completed within 6 weeks. Dosage frequency 2 times per day. Dosage type: Research participant must perform computerized health education activities with hands as well as task specific training directed by an occupational therapist |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have survived a unilateral stroke at least six months prior to enrollment
- Fugl Meyer Upper Extremity Score between 22-38.
Key exclusion criteria (1 listed)
- No individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches
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 |
|---|---|---|
| priming and task specific trainingThis task specific training protocol has been used in several clinical trials. | Behavioural | Bilateral Priming, Health Education |
Primary outcome
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints)
Time frame: value at 6 weeks minus value at baseline
The change score (Follow-up - Baseline) for the Chedoke Arm and Hand Activity Index 9 is reported. The change score scale ranges 0(min) to 63 (max). Higher scores indicate greater ability. Follow-up is at 6 weeks post treatment cessation. The scale measure bilateral activity performance.
1 secondary outcome
Change Score (Value at Follow-up - Value at Baseline) Fugl Meyer Upper Extremity Test of Function
Time frame: value at 6 weeks minus value at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33110623King EC, Doherty M, Corcos D, Stoykov ME. Examining recruitment feasibility and related outcomes in adults post-stroke. Pilot Feasibility Stud. 2020 Oct 24;6:160. doi: 10.1186/s40814-020-00696-w. eCollection 2020.
- Derived from this study: PubMed 31609714Stoykov ME, King E, David FJ, Vatinno A, Fogg L, Corcos DM. Bilateral motor priming for post stroke upper extremity hemiparesis: A randomized pilot study. Restor Neurol Neurosci. 2020;38(1):11-22. doi: 10.3233/RNN-190943.
- Individual participant dataSharing planned: No
Related trials for Stroke, Upper Extremity Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
Recruiting
ESTIM-UL: FES for Upper Limb Recovery After Stroke
Stroke, Post-Stroke Spasticity
Recruiting
Personalized Transcranial Direct Current Stimulation in Stroke Recovery
Stroke, Chronic Stroke
Recruiting
Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization
Stroke, Arm Weakness as a Consequence of Stroke
Active, not recruiting
rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke
Stroke, Hemiplegia
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.
Mary E Stoykov, PhD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing priming and task specific training in people with Stroke, Upper Extremity Hemiparesis, run by Rush University Medical Center 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 27 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Score of Chedoke Arm and Hand Activity Index Nine (CAHAI 9) Baseline to Follow-up (2 Timepoints) (time frame: value at 6 weeks minus value at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277028, which also lists 2 linked publications.
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 27 Oct 2023.