StrokeNCT01422005
Study of the Recovery of Muscle Function in the Arm/Hand After a Stroke
A study testing Simultaneous Bimanual training and Conventional Occupational Therapy in people with Stroke and Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to examine if practicing joint movements using specially designed devices can help in the recovery of muscle function in the arm/hand after a stroke. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Simultaneous Bimanual training and Conventional Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 12 Dec 2019
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to follow study instructions and likely to complete all required visits; ability to comply with the therapy protocol as assessed by the investigator; must be English speaking.
- Subjects must have had a unilateral stroke
Who cannot join
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Univeristy School of Medicine
New York, New York, 10016
About this study
Official title: Simultaneous Bimanual Training to Improve Motor Function Post-Stroke
The purpose of this study is to examine if practicing joint movements using specially designed devices can help in the recovery of muscle function in the arm/hand after a stroke. Subjects may qualify for participation in this study because they had a stroke and have had difficulty using their affected arm/hand ever since.
Read the detailed description
Stroke is a leading cause of long-term adult disability in the United States, and hemiparesis is the most common motor impairment that frequently leads to persistent deficits in hand function. The mechanisms of recovery of hand motor function after stroke are poorly understood, and the protocols used in clinical practice lack a solid scientific rationale. The long-term objective of this research is to understand the neural mechanisms underlying the recovery of voluntary motor functions in brain-injured patients in order to provide a more objective and scientific basis to rehabilitation protocols used in clinical practice.
These devices will be used to facilitate the training of either unimanual or bimanual movements that can be used both in the acute and chronic post-stroke period, even when there is little active movement in the affected upper extremity. The specially designed mechanical devices (BAT, PST and WIFIT), Psychophysical methods using an instrumented glove, and electromyographic recordings from upper extremity muscles to investigate the following specific aims in patients with post-stroke hemiparesis will lead to:
- greater extensor muscle activation and out of synergy movement compared with unimanual training facilitated by an external agent (e.g. another person).
- Bimanual training with the specially designed mechanical devices (BAT, PST and WIFIT) over 6 weeks will produce greater functional recovery in the affected upper extremity in patients with post-stroke hemiparesis, compared with conventional therapy.
- The gains in motor control and function will be greater in patients who begin bimanual training in the acute post-stroke phase (0-6) months, compared with those that begin in the chronic post-stroke phase (> 6 months).
- Conditions
- Stroke, Hemiparesis
- Being tested
- Simultaneous Bimanual training, Conventional Occupational Therapy
- Keywords
- Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Hand Function, Post Stroke, Neural mechanisms, Motor Control, Motor Function
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Bimanual trainingOther
Also called Device group, Control group
Patients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices.
Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy.
Conventional Occupational TherapyOther
Also called Control Group
Conventional Occupational Therapy will be given to patients in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Simultaneous Bimanual training: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices. Receives: Other: Simultaneous Bimanual training |
| Control Group | Active comparator | Conventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy. Receives: Other: Conventional Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of hand function
The outcome measures using the devices will include:
- hand function
- range of motion
- stiffness
- extent of impairment on the affected side
- temperature differences between the two sides of the body, and
- skin sensitivity to pressure.
Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.
Measured: Day 1
Secondary outcomes (1)
Measurement of Hand Function
The outcome measures using the devices will include:
- hand function
- range of motion
- stiffness
- extent of impairment on the affected side
- temperature differences between the two sides of the body, and
- skin sensitivity to pressure.
Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2011
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
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 NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- John R Rizzo, MD, Principal investigator, New York Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422005
- Sponsor's protocol ID
- 11-00118
- Other IDs
- R#: 11-00118
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2011
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Bimanual Training to Improve Motor Function Post-Stroke
- ClinicalTrials.gov ID
- NCT01422005
- Acronym / sponsor ID
- 11-00118
- Conditions
- Stroke, Hemiparesis
- Keywords
- Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Hand Function, Post Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jan 2011 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 23 Aug 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.
The purpose of this study is to examine if practicing joint movements using specially designed devices can help in the recovery of muscle function in the arm/hand after a stroke. Subjects may qualify for participation in this study because they had a stroke and have had difficulty using their affected arm/hand ever since.
Detailed description
Stroke is a leading cause of long-term adult disability in the United States, and hemiparesis is the most common motor impairment that frequently leads to persistent deficits in hand function. The mechanisms of recovery of hand motor function after stroke are poorly understood, and the protocols used in clinical practice lack a solid scientific rationale. The long-term objective of this research is to understand the neural mechanisms underlying the recovery of voluntary motor functions in brain-injured patients in order to provide a more objective and scientific basis to rehabilitation protocols used in clinical practice.
These devices will be used to facilitate the training of either unimanual or bimanual movements that can be used both in the acute and chronic post-stroke period, even when there is little active movement in the affected upper extremity. The specially designed mechanical devices (BAT, PST and WIFIT), Psychophysical methods using an instrumented glove, and electromyographic recordings from upper extremity muscles to investigate the following specific aims in patients with post-stroke hemiparesis will lead to:
- greater extensor muscle activation and out of synergy movement compared with unimanual training facilitated by an external agent (e.g. another person).
- Bimanual training with the specially designed mechanical devices (BAT, PST and WIFIT) over 6 weeks will produce greater functional recovery in the affected upper extremity in patients with post-stroke hemiparesis, compared with conventional therapy.
- The gains in motor control and function will be greater in patients who begin bimanual training in the acute post-stroke phase (0-6) months, compared with those that begin in the chronic post-stroke phase (> 6 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Simultaneous Bimanual trainingSimultaneous Bimanual training: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices. |
| Control Group | Active comparator | Other: Conventional Occupational TherapyConventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to follow study instructions and likely to complete all required visits; ability to comply with the therapy protocol as assessed by the investigator; must be English speaking.
- Subjects must have had a unilateral stroke
Key exclusion criteria (6 listed)
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
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 |
|---|---|---|
| Simultaneous Bimanual trainingAlso: Device group, Control groupPatients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices. Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy. | Other | Experimental group |
| Conventional Occupational TherapyAlso: Control GroupConventional Occupational Therapy will be given to patients in the control group. | Other | Control Group |
Primary outcome
Measurement of hand function
Time frame: Day 1
The outcome measures using the devices will include: * hand function * range of motion * stiffness * extent of impairment on the affected side * temperature differences between the two sides of the body, and * skin sensitivity to pressure. Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.
1 secondary outcome
Measurement of Hand Function
Time frame: Day 84
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 19 Aug 2020.
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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.
John R Rizzo, MD principal investigator
New York Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Bimanual training and Conventional Occupational Therapy in people with Stroke and Hemiparesis, run by NYU Langone Health 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 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: finished, as of the sponsor's last update on 19 Aug 2020. 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 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?
Measurement of hand function (time frame: Day 1). 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 19 Aug 2020.