StrokeNCT07666165
Functional Neuroimaging and Motor Recovery After Stroke
A study testing Conventional Physical Therapy Intervention in people with Stroke, run by University of Delaware at 2 sites in United States.
Trial summary
The primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Conventional Physical Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2022to 22 Dec 2022
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age comprised between 35 and 85 years
- diagnosis of a single unilateral subcortical stroke event occurring more than 6 months prior to enrollment resulting in upper extremity paresis (weakness) of one arm,
- presence of residual upper extremity motor function, demonstrated by the ability to actively supinate (rotate hand toward "palm-up" direction) the paretic forearm to neutral and to voluntarily extend (bend wrist toward back of the hand) and radially deviate (bend wrist toward thumb side) the paretic wrist at least 5 degrees,
- adequate cognition to provide informed consent and fully follow instruction (MOCA score of at least 19),
- English-speaking
Who cannot join
- more than 1 stroke,
- clinical or radiological evidence of damage to the cerebellum or brainstem,
- contra-indications to MRI (i.e. pacemakers, cochlear implants, neurostimulators, metallic implants, pregnancy, claustrophobia, permanent metal braces, or other implanted devices not approved for 3T imaging - see CBBI MRI Safety Checklist for details),
- weight >400 pounds and/or unable or too uncomfortable to fit the torso into the MRI bore,
- musculoskeletal or other neurologic (non-stroke) conditions directly affecting the paretic wrist or hand function (such as tendinitis, arthritis, hand or wrist orthopaedic surgery in the last 6 months, diagnosis of carpal tunnel, multiple sclerosis, Parkinson's disease, etc.)
- inability to follow instructions on the motor task or understand protocol description (e.g. due to cognitive deficits)
- participation in additional Occupational or Physical Therapy in which they are doing hand/arm exercises while enrolled in this study
- received Botox injections in the past 3 months prior to or during participation in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Biomedical and Brain Imaging
Newark, Delaware, 19713
STAR Health Sciences Complex
Newark, Delaware, 19713
About this study
The primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke.
This study involves individuals with chronic motor impairment resulting from stroke. The procedures include one fMRI session (baseline), followed by twelve training visits (2 or 3 times per week over 4-5 weeks) focused on training motor function of the hand and wrist conducted with a physical therapist. During imaging, participants interact with an MRI-compatible joystick that will cue participants to move their wrist in a controlled way. Before and after the training program, subjects will undergo behavioral testing with a physical therapist to quantify changes in clinical measures of impairment.
- Conditions
- Stroke
- Being tested
- Conventional Physical Therapy Intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy InterventionBehavioural
The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy Intervention | Experimental | The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10. Receives: Behavioral: Conventional Physical Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity
The primary outcome is the goodness of fit (R^2) of a regression model relating brain connectivity measures (predictors) to gains in motor function after stroke (clinical measurement).
Predictors: resting-state functional connectivity measured using resting-state fMRI (rs-fMRI). Connectivity is quantified as Fisher-transformed correlation coefficients (z scores, unitless) of signal measured in pairs of regions (edges) within the cortico-thalamic-cerebellar network. Predictors include baseline (pre-task) connectivity and connectivity changes calculated as the difference between post-task and pre-task rs-fMRI measurements.
Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE.
Outcome: model goodness of fit (R^2, unitless). We use a custom LASSO-based variable selection method to construct the final model given multiple predictors and quantify the model fit via R^2.
Measured: Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.
Secondary outcomes (1)
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from corticospinal tract injury
The secondary outcome is the goodness of fit (R^2) of a linear regression model relating corticospinal tract injury (predictor) to gains in motor function after stroke (clinical measurement).
Predictor: percent corticospinal tract injury (%CST injury) quantified using a structural MRI brain scan (FLAIR). The FLAIR image shows the location and volume of lesioned tissue, and %CST injury is quantified as the percentage of CST axon bundles (derived from a previously published healthy template) that overlap with the lesion (predictor units: percent damaged axon bundles).
Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE.
Outcome: model goodness of fit (R^2, unitless). We use linear regression to relate %CST injury to the change in FM-UE and quantify the model's fit via R^2.
Measured: Structural brain scan (FLAIR) is acquired once during the MRI visit at Baseline. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start25 Jan 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666165
- Sponsor's protocol ID
- 1125467
- Other IDs
- 17SDG33690002
- Status last verified
- May 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging and Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT07666165
- Acronym / sponsor ID
- 1125467
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 24 Jun 2026 (actual)
- 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 primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke.
This study involves individuals with chronic motor impairment resulting from stroke. The procedures include one fMRI session (baseline), followed by twelve training visits (2 or 3 times per week over 4-5 weeks) focused on training motor function of the hand and wrist conducted with a physical therapist. During imaging, participants interact with an MRI-compatible joystick that will cue participants to move their wrist in a controlled way. Before and after the training program, subjects will undergo behavioral testing with a physical therapist to quantify changes in clinical measures of impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Intervention | Experimental | Behavioral: Conventional Physical Therapy InterventionThe training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age comprised between 35 and 85 years
- diagnosis of a single unilateral subcortical stroke event occurring more than 6 months prior to enrollment resulting in upper extremity paresis (weakness) of one arm,
- presence of residual upper extremity motor function, demonstrated by the ability to actively supinate (rotate hand toward "palm-up" direction) the paretic forearm to neutral and to voluntarily extend (bend wrist toward back of the hand) and radially deviate (bend wrist toward thumb side) the paretic wrist at least 5 degrees,
- adequate cognition to provide informed consent and fully follow instruction (MOCA score of at least 19),
- English-speaking
Key exclusion criteria (8 listed)
- more than 1 stroke,
- clinical or radiological evidence of damage to the cerebellum or brainstem,
- contra-indications to MRI (i.e. pacemakers, cochlear implants, neurostimulators, metallic implants, pregnancy, claustrophobia, permanent metal braces, or other implanted devices not approved for 3T imaging - see CBBI MRI Safety Checklist for details),
- weight >400 pounds and/or unable or too uncomfortable to fit the torso into the MRI bore,
- musculoskeletal or other neurologic (non-stroke) conditions directly affecting the paretic wrist or hand function (such as tendinitis, arthritis, hand or wrist orthopaedic surgery in the last 6 months, diagnosis of carpal tunnel, multiple sclerosis, Parkinson's disease, etc.)
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 |
|---|---|---|
| Conventional Physical Therapy InterventionThe training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10. | Behavioural | Conventional Physical Therapy Intervention |
Primary outcome
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity
Time frame: Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.
The primary outcome is the goodness of fit (R^2) of a regression model relating brain connectivity measures (predictors) to gains in motor function after stroke (clinical measurement). Predictors: resting-state functional connectivity measured using resting-state fMRI (rs-fMRI). Connectivity is quantified as Fisher-transformed correlation coefficients (z scores, unitless) of signal measured in pairs of regions (edges) within the cortico-thalamic-cerebellar network. Predictors include baseline (pre-task) connectivity and connectivity changes calculated as the difference between post-task and pre-task rs-fMRI measurements. Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE. Outcome: model goodness of fit (R^2, unitless). We use a custom LASSO-based variable selection method to construct the final model given multiple predictors and quantify the model fit via R^2.
1 secondary outcome
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from corticospinal tract injury
Time frame: Structural brain scan (FLAIR) is acquired once during the MRI visit at Baseline. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy Intervention in people with Stroke, run by University of Delaware at 2 sites 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 5 inclusion and 8 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity (time frame: Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.). 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 Jun 2026.