StrokePhase 1DOSENCT01749358

Dose Optimization for Stroke Evaluation

A Phase 1 study testing Accelerated Skill Acquisition Program (ASAP) and Active Monitoring in people with Stroke and Cerebrovascular Disorders, run by University of Southern California 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

Who is it for?: Ages 21 years and older
Conditions the study is for: Stroke, Cerebrovascular Disorders, Brain Ischemia
What is being tested?: Accelerated Skill Acquisition Program (ASAP) and Active Monitoring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Aug 2016
Phase: Phase 1
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ischemic or hemorrhagic stroke that occured at least 6 months ago.
At least 21 years of age
Persistent arm and hand weakness, with some ability to release a grasp
Able to provide consent to participate
No history of a medical condition that limited arm or hand use prior to the stroke
Medically stable
Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus.
Able to communicate in English or Spanish.

Who cannot join

Severe upper extremity sensory impairment
Neglect
Current major depressive disorder
Severe arthritis or orthopedic problems that limit arm or hand movement
Pain that interferes with daily activities
Currently enrolled in other rehabilitation or drug intervention studies

Show all 9Show fewer

Living too far from the training site to participate reliably
Receiving oral or injected anti-spasticity medications during study treatment.
Pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Southern California-Health Sciences Campus
Los Angeles, California, 90089

Other trials in United States

About this study

Official title: Optimizing the Dose of Rehabilitation After Stroke.

This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.

Conditions: Stroke, Cerebrovascular Disorders, Brain Ischemia, Infarction
Being tested: Accelerated Skill Acquisition Program (ASAP), Active Monitoring
Keywords: stroke, hemiparesis, physical therapy, occupational therapy, neurorehabilitation, patient focused, motor learning, motor control, skill acquisition, skill training, motor recovery, task oriented training, task specific training, arm function, hand function, upper extremity, arm therapy, physical rehabilitation, arm rehabilitation, motor function
Medical subject headings: Stroke, Cerebrovascular Disorders, Brain Ischemia, Infarction, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Accelerated Skill Acquisition Program (ASAP)Behavioural
A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
Active MonitoringBehavioural
This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.

Study groups in NCT01749358
Study group	Role	What they receive
High Therapy Dose	Experimental	Sixty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist). Receives: Behavioral: Accelerated Skill Acquisition Program (ASAP)
Moderate Therapy Dose	Experimental	Thirty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist). Receives: Behavioral: Accelerated Skill Acquisition Program (ASAP)
Low Therapy Dose	Experimental	Fifteen total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist). Receives: Behavioral: Accelerated Skill Acquisition Program (ASAP)
Active Monitoring	Other	This is an observation only group. Receives: Behavioral: Active Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

Bilateral Arm Reaching Test (BART)
BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed two times per month for the four months following randomization, and one time a month for 6 months during the follow-up period to assess changes in upper extremity use relative to dosage of therapy.
Measured: Change from Baseline to up to 4 months post-randomization
Wolf Motor Function Test (WMFT)
Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.
Measured: Change from Baseline to up to 4 months post-randomization
Motor Activity Log (MAL)
Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.
Measured: Change from Baseline to up to 4 months post-randomization
Bilateral Arm Reaching Test (BART)
BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed 2 times at Baseline, pre- and post- intervention and 1 time a month for 6 months during follow-up to assess changes in upper extremity use relative to dosage of therapy.
Measured: Change from Baseline to up to 10 months post-randomization
Wolf Motor Function Test (WMFT)
Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.
Measured: Change from Baseline to up to 10 months post-randomization
Motor Activity Log (MAL)
Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.
Measured: Change from Baseline to up to 10 months post-randomization

Secondary outcomes (4)

Stroke Impact Scale (SIS)
A self-report measure to assess the ways in which an individual's health and life are impacted after a stroke. SIS will be used to assess changes in participant self-report of the impact of the stroke on health and life relative to dosage of physical therapy.
Measured: Change from Baseline to up to 4 months post-randomization
Upper Extremity Fugl-Meyer (UEFM)
A test of motor function and sensation for the arm that is most affected by the stroke. UEFM will assess change in motor function relative to dose of physical therapy.
Measured: Change from Baseline to up to 4 months post-randomization
Stroke Impact Scale (SIS)
A self-report measure to assess the ways in which an individual's health and life are impacted after a stroke. SIS will be used to assess changes in participant self-report of the impact of the stroke on health and life relative to dosage of physical therapy.
Measured: Change from Baseline to up to 10 months post-randomization
Upper Extremity Fugl-Meyer (UEFM)
A test of motor function and sensation for the arm that is most affected by the stroke. UEFM will assess change in motor function relative to dose of physical therapy.
Measured: Change from Baseline to up to 10 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Aug 2016

First posted13 Dec 2012 (estimated)
Study startMar 2012
Primary completionAug 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01749358
Sponsor's protocol ID: R01HD065438
Other IDs: R01HD065438
Acronym: DOSE
Status last verified: Oct 2016
First submitted: 25 Jun 2012
Last updated: 6 Apr 2017
Results posted: No
Data monitoring committee: No

Publications

Schweighofer N, Ye D, Luo H, D'Argenio DZ, Winstein C. Long-term forecasting of a motor outcome following rehabilitation in chronic stroke via a hierarchical bayesian dynamic model. J Neuroeng Rehabil. 2023 Jun 29;20(1):83. doi: 10.1186/s12984-023-01202-y.
PubMed 37386512
Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
PubMed 31164067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing the Dose of Rehabilitation After Stroke.
ClinicalTrials.gov ID: NCT01749358
Acronym / sponsor ID: DOSE / R01HD065438
Conditions: Stroke, Cerebrovascular Disorders, Brain Ischemia, Infarction
Keywords: stroke, hemiparesis, physical therapy, occupational therapy, neurorehabilitation, patient focused, motor learning, motor control
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Mar 2012
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 13 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
High Therapy Dose	Experimental	Behavioral: Accelerated Skill Acquisition Program (ASAP)Sixty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
Moderate Therapy Dose	Experimental	Behavioral: Accelerated Skill Acquisition Program (ASAP)Thirty total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
Low Therapy Dose	Experimental	Behavioral: Accelerated Skill Acquisition Program (ASAP)Fifteen total hours of ASAP therapy--challenging, intensive and meaningful practice of tasks of your choice in a collaborative partnership with your personal trainer (therapist).
Active Monitoring	Other	Behavioral: Active MonitoringThis is an observation only group.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Ischemic or hemorrhagic stroke that occured at least 6 months ago.
At least 21 years of age
Persistent arm and hand weakness, with some ability to release a grasp
Able to provide consent to participate
No history of a medical condition that limited arm or hand use prior to the stroke

Key exclusion criteria (9 listed)

Severe upper extremity sensory impairment
Neglect
Current major depressive disorder
Severe arthritis or orthopedic problems that limit arm or hand movement
Pain that interferes with daily activities

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
Accelerated Skill Acquisition Program (ASAP)A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.	Behavioural	High Therapy Dose, Low Therapy Dose, Moderate Therapy Dose
Active MonitoringThis is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.	Behavioural	Active Monitoring

Primary outcome

Bilateral Arm Reaching Test (BART)
Time frame: Change from Baseline to up to 4 months post-randomization
BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed two times per month for the four months following randomization, and one time a month for 6 months during the follow-up period to assess changes in upper extremity use relative to dosage of therapy.
Wolf Motor Function Test (WMFT)
Time frame: Change from Baseline to up to 4 months post-randomization
Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.
Motor Activity Log (MAL)
Time frame: Change from Baseline to up to 4 months post-randomization
Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.
Bilateral Arm Reaching Test (BART)
Time frame: Change from Baseline to up to 10 months post-randomization
BART is a laboratory-based timed-reaching task for people with stroke that was developed to evaluate upper extremity use in free-choice and forced-use scenarios. BART will be performed 2 times at Baseline, pre- and post- intervention and 1 time a month for 6 months during follow-up to assess changes in upper extremity use relative to dosage of therapy.
Wolf Motor Function Test (WMFT)
Time frame: Change from Baseline to up to 10 months post-randomization
Tests arm function based on time to complete 15 tasks performed with each arm. WMFT will be used to assess change in arm function relative to dose of physical therapy.
Motor Activity Log (MAL)
Time frame: Change from Baseline to up to 10 months post-randomization
Semi-structured interview in which participants are asked to rate the quality of movement (QOM) of their more affected arm for 28 activities of daily living. MAL is used to assess changes in participant perspective of arm use in daily life relative to dose of physical therapy.

4 secondary outcomes

Stroke Impact Scale (SIS)
Time frame: Change from Baseline to up to 4 months post-randomization
Upper Extremity Fugl-Meyer (UEFM)
Time frame: Change from Baseline to up to 4 months post-randomization
Stroke Impact Scale (SIS)
Time frame: Change from Baseline to up to 10 months post-randomization
Upper Extremity Fugl-Meyer (UEFM)
Time frame: Change from Baseline to up to 10 months post-randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Derived from this study: PubMed 37386512Schweighofer N, Ye D, Luo H, D'Argenio DZ, Winstein C. Long-term forecasting of a motor outcome following rehabilitation in chronic stroke via a hierarchical bayesian dynamic model. J Neuroeng Rehabil. 2023 Jun 29;20(1):83. doi: 10.1186/s12984-023-01202-y.
Derived from this study: PubMed 31164067Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.

Related trials for Stroke

RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion

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.

Carolee Winstein, PhD, PT, FAPTA principal investigator

University of Southern California

Nicolas Schweighofer, PhD principal investigator

University of Southern California

Clarisa Martinez, PT, DPT study director

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 9 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 6 Apr 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

What does the primary outcome measure?

Bilateral Arm Reaching Test (BART) (time frame: Change from Baseline to up to 4 months post-randomization). The study lists 6 primary outcomes in all. 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 NCT01749358, 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 6 Apr 2017.