HemiparesisNCT05560867
Neural Mechanisms of Motor Recovery With Technology Assisted Training
A study testing robot-assisted training in people with Hemiparesis and Stroke Sequelae, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hemiparesis, Stroke Sequelae
- What is being tested?
- robot-assisted training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2022to 1 May 2024
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 88 years
- Able to provide informed consent based on Evaluation to Sign Informed Consent.
- History of clinically defined, unilateral hemiparetic stroke, with radiologic exclusion of other possible diagnosis, causing weakness in 1 arm 6 months or more prior to enrollment.
- Fugl-Meyer upper extremity score <= 50 at time of enrollment
- Medically stable to participate in the study and have mobility, visual, and cognitive abilities sufficient to follow directions and engage in the gamified therapeutic tasks.
Who cannot join
- Undergoing any significant medical treatments requiring regular visits, treatments, or therapies at the time of enrollment or anytime during the study.
- Hair or scalp implant that would not allow near infrared spectroscopy probes to sit on scalp.
- Injection of botulinum toxin to the paretic arm within 3 months of enrollment or during the study or injection of daxibotulinumtoxinA within 6 months of enrollment or during the study
- Orthopedic, rheumatologic, or other medical disease that would make the procedures of participation dangerous, painful, or uncomfortable.
- Contraindications to MRI, including intracranial magnetic items, implanted pumps, pacemakers, or stimulators, or claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.
Read the detailed description
Study Description: This study will investigate the neural mechanisms of technology-assisted-training for post-stroke hemiparesis by using functional near-infrared-spectroscopy (fNIRS). Patients with hemiparesis affecting the arm will be brought in for 3 weeks of technology-assisted-training while having fNIRS recordings of their brain activity. Analysis of these brain activation patterns will help determine what areas of the brain are necessary to respond to this type of training.
Objectives: 1) to investigate brain network activity changes that occur during technology-assisted-training and 2) to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training.
Endpoints: The study will evaluate increases in cortical connectivity between bilateral primary motor areas, angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments. The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training.
Study Population: Patients of either gender with chronic (at least 6 months or more) hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties.
- Conditions
- Hemiparesis, Stroke Sequelae
- Being tested
- robot-assisted training
- Keywords
- stroke, robot-assisted rehabilitation, neural networks, fnirs, rehabilitation
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted trainingDevice
Also called IMT InMotion Wrist Robot, IMT InMotion2 Shoulder-Elbow Robot, IMT InMotion2 Planar Robot
These training platforms use gamified training tasks to improve motor control in the hemiparetic arm
| Study group | Role | What they receive |
|---|---|---|
| Patient Robot-Assisted Training Group | Other | Patients will undergo robot-assisted physical therapy three times a week, for a total of 9 sessions, while functional near-infrared spectroscopy data is collected. Receives: Device: robot-assisted training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cortical connectivity measures as assessed using MRI
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum. MRI sequences include T1 MPRAGE, BOLD (T2*), FLAIR T2, ASL, and DTI.
Measured: Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)
Changes in cortical connectivity measures as assessed using fNIRS
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.
Measured: Baseline fNIRS collected at the time of study enrollment, with repeated fNIRS measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Secondary outcomes (9)
Changes in arm kinematics (position)
Arm kinematics measures of position collected by the rehabilitation training technology devices
Measured: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in arm kinematics (velocity)
Arm kinematics measures of velocity collected by the rehabilitation training technology devices
Measured: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in arm kinematics (acceleration)
Arm kinematics measures of acceleration collected by the rehabilitation training technology devices
Measured: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")
Standardized bedside test examining the degree of motor impairment for the arm/hand. Scores range from 0 - 66 with higher scores representing better recovery.
Measured: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in Action Research Arm Test
Standardized bedside test examining behavioral tasks for the arm/hand. Scores range from 0-57 points, with a maximum score of 57 points indicating better performance.
Measured: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
Changes in Wolf Motor Function Test ("WMFT")
Standardized bedside test examining behavioral tasks for the arm/hand. Score Ranges Minimum 0 to Maximum 75; Lower scores are indicative of lower functioning levels.
Measured: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
Changes in Shoulder Abduction Finger Extension ("SAFE") score
Standardized bedside test examining strength of the arm/hand. Scores range from 0-10 with higher scores representing better strength.
Measured: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in NIH Stroke Scale Score ("NIHSS")
Standardized bedside test to assess stroke symptoms. Scores range from 0 - 42, where higher scores indicate greater symptom severity.
Measured: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in Stroke Impact Scale ("SIS")
Standardized questionnaire examining patient perceptions of how stroke impacts their function and quality of life. Scores range from 0 to 100 with higher scores indicating a higher quality of life.
Measured: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start14 Dec 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Why it stopped: Technical issues with study robotics preventing completion of the research intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robynne Braun, MD, PhD, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560867
- Sponsor's protocol ID
- HP-00093740
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
- ClinicalTrials.gov ID
- NCT05560867
- Acronym / sponsor ID
- HP-00093740
- Conditions
- Hemiparesis, Stroke Sequelae
- Keywords
- stroke, robot-assisted rehabilitation, neural networks, fnirs, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical issues with study robotics preventing completion of the research intervention
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 29 Sep 2022 (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.
Stroke is a leading cause of disability that often impairs arm function and activities of daily living. The costs of rehabilitation are significant and practical constraints often limit therapy to the first few months after stroke. However many studies have shown that patients in the later stages post-stroke can still continue to benefit from rehabilitation. Technology-assisted therapy may offer a means to efficiently provide ongoing therapies to patients in the later stages (>6 months) post-stroke. This study will determine which patients are best able to benefit from this therapy approach, and will also expand our knowledge of which brain structures need to be intact for patients to benefit from technology-assisted training. The results of this study will help to improve rehabilitation and quality of life for disabled Americans.
Detailed description
Study Description: This study will investigate the neural mechanisms of technology-assisted-training for post-stroke hemiparesis by using functional near-infrared-spectroscopy (fNIRS). Patients with hemiparesis affecting the arm will be brought in for 3 weeks of technology-assisted-training while having fNIRS recordings of their brain activity. Analysis of these brain activation patterns will help determine what areas of the brain are necessary to respond to this type of training.
Objectives: 1) to investigate brain network activity changes that occur during technology-assisted-training and 2) to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training.
Endpoints: The study will evaluate increases in cortical connectivity between bilateral primary motor areas, angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments. The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training.
Study Population: Patients of either gender with chronic (at least 6 months or more) hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Robot-Assisted Training Group | Other | Device: robot-assisted trainingPatients will undergo robot-assisted physical therapy three times a week, for a total of 9 sessions, while functional near-infrared spectroscopy data is collected. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 88 years
- Able to provide informed consent based on Evaluation to Sign Informed Consent.
- History of clinically defined, unilateral hemiparetic stroke, with radiologic exclusion of other possible diagnosis, causing weakness in 1 arm 6 months or more prior to enrollment.
- Fugl-Meyer upper extremity score <= 50 at time of enrollment
- Medically stable to participate in the study and have mobility, visual, and cognitive abilities sufficient to follow directions and engage in the gamified therapeutic tasks.
Key exclusion criteria (5 listed)
- Undergoing any significant medical treatments requiring regular visits, treatments, or therapies at the time of enrollment or anytime during the study.
- Hair or scalp implant that would not allow near infrared spectroscopy probes to sit on scalp.
- Injection of botulinum toxin to the paretic arm within 3 months of enrollment or during the study or injection of daxibotulinumtoxinA within 6 months of enrollment or during the study
- Orthopedic, rheumatologic, or other medical disease that would make the procedures of participation dangerous, painful, or uncomfortable.
- Contraindications to MRI, including intracranial magnetic items, implanted pumps, pacemakers, or stimulators, or claustrophobia.
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 |
|---|---|---|
| robot-assisted trainingAlso: IMT InMotion Wrist Robot, IMT InMotion2 Shoulder-Elbow Robot, IMT InMotion2 Planar RobotThese training platforms use gamified training tasks to improve motor control in the hemiparetic arm | Device | Patient Robot-Assisted Training Group |
Primary outcome
Changes in cortical connectivity measures as assessed using MRI
Time frame: Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum. MRI sequences include T1 MPRAGE, BOLD (T2*), FLAIR T2, ASL, and DTI.
Changes in cortical connectivity measures as assessed using fNIRS
Time frame: Baseline fNIRS collected at the time of study enrollment, with repeated fNIRS measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.
9 secondary outcomes
Changes in arm kinematics (position)
Time frame: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in arm kinematics (velocity)
Time frame: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in arm kinematics (acceleration)
Time frame: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")
Time frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in Action Research Arm Test
Time frame: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
Changes in Wolf Motor Function Test ("WMFT")
Time frame: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
Changes in Shoulder Abduction Finger Extension ("SAFE") score
Time frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in NIH Stroke Scale Score ("NIHSS")
Time frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
Changes in Stroke Impact Scale ("SIS")
Time frame: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment)
Results and safety
The study was stopped early (reason given: Technical issues with study robotics preventing completion of the research intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted training in people with Hemiparesis and Stroke Sequelae, run by University of Maryland, Baltimore 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 5 inclusion and 5 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 26 Aug 2024. 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: Technical issues with study robotics preventing completion of the research intervention). 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?
Changes in cortical connectivity measures as assessed using MRI (time frame: Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)). 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 26 Aug 2024.