Stroke With HemiparesisNCT01977027
Strategies for Recovery of Dexterity Post Stroke
A study testing Alternate Hand Training or Affected Hand Training in people with Stroke With Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial summary
Motor learning can be affected by the sensory difficulties that may be experienced as a result of a stroke. This study will help us better understand what kinds of sensory information can help with the re-learning of grasping with the affected hand despite the sensory difficulties produced by the stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke With Hemiparesis
- What is being tested?
- Alternate Hand Training or Affected Hand Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 10 May 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to read/write in English
- Age > 18 yrs
- Radiologically verified stroke > 4 months old (3T structural MRI)
- Moderate arm motor impairment (Fugl-Meyer Scale < 60/66)
- Ability to reach, grasp and lift the test objects with the affected side as assessed by the PI
- Willingness to complete all clinical assessments and MRI, and comply with training protocols
- Ability to give informed consent and HIPPA certificationsPlease list all exclusion criteria for study:
Who cannot join
- Sensorimotor impairments in the unaffected hand
- Severe visual or sensory impairment, including neglect on the affected side
- Significant cognitive dysfunction (score < 24 on Folstein's Mini Mental Status Examination)
- Severe or unstable spasticity on treatment with Botulinum toxin or intrathecal baclofen
- Depression (Geriatric Depression Scale score <11)
- Major disability (modified Rankin Scale > 4)
- Previous neurological illness, complicated medical condition, or significant injury to either upper extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Motor learning can be affected by the sensory difficulties that may be experienced as a result of a stroke. This study will help us better understand what kinds of sensory information can help with the re-learning of grasping with the affected hand despite the sensory difficulties produced by the stroke.
Read the detailed description
The purpose of this study is to develop, refine and test the 'alternate hand training strategy' to facilitate adaptation, repetition and relearning to restore hand function after stroke. The three aims are: to restore adaptation (Aim 1), facilitate grasp efficiency and normal directional biases during repetition (Aim 2), and enhance the rate of learning to improve hand function and quality of life post stroke (Aim 3).
Hypotheses: We hypothesize that alternate hand training will increase the rate of learning and lead to greater improvement in hand function. The results will inform dosing of therapy for optimal relearning.
- Conditions
- Stroke With Hemiparesis
- Being tested
- Alternate Hand Training or Affected Hand Training
- Keywords
- Rehabilitation, Fingers, Grasp, Strength, Hand Function, Motor Function, Post Stroke, Brain Infraction, Biomechanis, Neuronal Plasticity, Weight-Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Hand Training or Affected Hand TrainingOther
Participants will receive a training intervention with either the Alternate Hand Training Strategy, or Affected Hand Training alone.
| Study group | Role | What they receive |
|---|---|---|
| Stroke & age-matched Controls | Other | Alternate Hand Training or Affected Hand Training:
40 patients with stroke and 40 control subjects will participate over 7 visits. After completion of informed consent, subjects will undergo clinical assessments (Visit 1) which will involve testing for kinesthetic, visual, tactile and motor impairments and upper limb function. Visit 2, subjects will undergo no contrast MRI to identify lesion location. Healthy controls will not be imaged.
Visits 3-7 will involve psychophysical experiments to test adaptation with short-term Alternate Hand Training and Affected Hand Training. During 5 visits the subjects will grasp and lift an instrumented grip device of different weights, textures and shapes while data is being collected via surface electrodes from, upper arm and back muscles. Receives: Other: Alternate Hand Training or Affected Hand Training |
| Phase 2 - Stroke ONLY | Other | Alternate Hand Training or Affected Hand Training:
Subjects will be randomized into two groups one receiving Alternate Hand Training and the other receiving Affected Hand Training. The groups will be matched by age, gender, handedness, side of lesion, extent of motor impairment and lesion location. They will complete 17 Study visits.
Visits 1 and 2 will involve clinical assessments and MRI. Visit 3. Pre-intervention assessments involving grasping and lifting objects of different weights, textures and shapes while fingertip forces, finger and arm movements. Muscle activity and performance is measured.
Visits 4-15. Subjects will participate in 12 training visits for 1 hour a day, twice a week for 6 weeks.
Visits 16-17. Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments (in 2 visits) immediately after 6-weeks of training, and another 6 weeks later. Receives: Other: Alternate Hand Training or Affected Hand Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Phase 1: Adaptation of fingertip forces and movements during grasping.
5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.
Measured: 6 weeks
For Phase 2: Change in Hand function
Subjects will be randomized to Alternate Hand Training or Affected Hand Training arms and receive training twice a week for 6 weeks.
Measured: 6 weeks
Secondary outcomes (1)
Phase 2 - Maintenance of hand function
Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments 6-weeks after the end of training.
Measured: 6 weeks after end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startAug 2013
- Primary completion10 May 2019
- Study completion10 May 2019
Why it stopped: PI left insitution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke With HemiparesisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- John R Rizzo, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977027
- Sponsor's protocol ID
- 12-03117
- Other IDs
- 1R01HD071978-01A1102617, 1R01HD071978-01
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2013
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Recovery of Dexterity Post Stroke
- ClinicalTrials.gov ID
- NCT01977027
- Acronym / sponsor ID
- 12-03117
- Conditions
- Stroke With Hemiparesis
- Keywords
- Rehabilitation, Fingers, Grasp, Strength, Hand Function, Motor Function, Post Stroke, Brain Infraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left insitution
- Enrolment
- 91 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2013
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 6 Nov 2013 (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.
Motor learning can be affected by the sensory difficulties that may be experienced as a result of a stroke. This study will help us better understand what kinds of sensory information can help with the re-learning of grasping with the affected hand despite the sensory difficulties produced by the stroke.
Detailed description
The purpose of this study is to develop, refine and test the 'alternate hand training strategy' to facilitate adaptation, repetition and relearning to restore hand function after stroke. The three aims are: to restore adaptation (Aim 1), facilitate grasp efficiency and normal directional biases during repetition (Aim 2), and enhance the rate of learning to improve hand function and quality of life post stroke (Aim 3).
Hypotheses: We hypothesize that alternate hand training will increase the rate of learning and lead to greater improvement in hand function. The results will inform dosing of therapy for optimal relearning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke & age-matched Controls | Other | Other: Alternate Hand Training or Affected Hand TrainingAlternate Hand Training or Affected Hand Training: 40 patients with stroke and 40 control subjects will participate over 7 visits. After completion of informed consent, subjects will undergo clinical assessments (Visit 1) which will involve testing for kinesthetic, visual, tactile and motor impairments and upper limb function. Visit 2, subjects will undergo no contrast MRI to identify lesion location. Healthy controls will not be imaged. Visits 3-7 will involve psychophysical experiments to test adaptation with short-term Alternate Hand Training and Affected Hand Training. During 5 visits the subjects will grasp and lift an instrumented grip device of different weights, textures and shapes while data is being collected via surface electrodes from, upper arm and back muscles. |
| Phase 2 - Stroke ONLY | Other | Other: Alternate Hand Training or Affected Hand TrainingAlternate Hand Training or Affected Hand Training: Subjects will be randomized into two groups one receiving Alternate Hand Training and the other receiving Affected Hand Training. The groups will be matched by age, gender, handedness, side of lesion, extent of motor impairment and lesion location. They will complete 17 Study visits. Visits 1 and 2 will involve clinical assessments and MRI. Visit 3. Pre-intervention assessments involving grasping and lifting objects of different weights, textures and shapes while fingertip forces, finger and arm movements. Muscle activity and performance is measured. Visits 4-15. Subjects will participate in 12 training visits for 1 hour a day, twice a week for 6 weeks. Visits 16-17. Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments (in 2 visits) immediately after 6-weeks of training, and another 6 weeks later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to read/write in English
- Age > 18 yrs
- Radiologically verified stroke > 4 months old (3T structural MRI)
- Moderate arm motor impairment (Fugl-Meyer Scale < 60/66)
- Ability to reach, grasp and lift the test objects with the affected side as assessed by the PI
Key exclusion criteria (7 listed)
- Sensorimotor impairments in the unaffected hand
- Severe visual or sensory impairment, including neglect on the affected side
- Significant cognitive dysfunction (score < 24 on Folstein's Mini Mental Status Examination)
- Severe or unstable spasticity on treatment with Botulinum toxin or intrathecal baclofen
- Depression (Geriatric Depression Scale score <11)
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 |
|---|---|---|
| Alternate Hand Training or Affected Hand TrainingParticipants will receive a training intervention with either the Alternate Hand Training Strategy, or Affected Hand Training alone. | Other | Phase 2 - Stroke ONLY, Stroke & age-matched Controls |
Primary outcome
For Phase 1: Adaptation of fingertip forces and movements during grasping.
Time frame: 6 weeks
5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.
For Phase 2: Change in Hand function
Time frame: 6 weeks
Subjects will be randomized to Alternate Hand Training or Affected Hand Training arms and receive training twice a week for 6 weeks.
1 secondary outcome
Phase 2 - Maintenance of hand function
Time frame: 6 weeks after end of training
Results and safety
The study was stopped early (reason given: PI left insitution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Hand Training or Affected Hand Training in people with Stroke With 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 7 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 24 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 was stopped early (reason given: PI left insitution). 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?
For Phase 1: Adaptation of fingertip forces and movements during grasping. (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 24 Aug 2020.