Stroke, AcuteNCT05106595
Bimanual Arm Training in Acute Stroke
An observational study of Stroke, Acute and Upper Extremity Paresis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Recent studies have shown that completing bilateral simultaneous movements during upper extremity practice may result in facilitation of coactivation and interhemispheric activation of both the ipsilesional and contralesional brain areas, with one limb entraining the other and enabling the limbs to function as a unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Upper Extremity Paresis
- What is being tested?
- Bimanual Arm Trainer
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2022to 14 Nov 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with acute or sub-acute stroke, with upper extremity paresis, admitted to an Acute Inpatient Rehab (IRF/AIR) unit.
Who may be able to join
- Diagnosis of acute stroke.
- Score of <17 on admission ARAT.
- Participation ≥ 3 BAT training sessions.
Who cannot join
- Impaired cognition impacting ability to participate in virtual reality system
- Pain resulting in poor tolerance of range of motion.
- Impaired sitting balance or poor tolerance of sitting in upright posture in chair without armrests.
- Spasticity in the affected upper extremity Modified Ashworth Scale (MAS) of 3 or greater.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Specialty Hospital
Baltimore, Maryland, 21224
About this study
Official title: Use of a Bimanual Arm Training Device in Acute Inpatient Stroke Rehabilitation, a Pre-post Cohort Study
Recent studies have shown that completing bilateral simultaneous movements during upper extremity practice may result in facilitation of coactivation and interhemispheric activation of both the ipsilesional and contralesional brain areas, with one limb entraining the other and enabling the limbs to function as a unit. Other research has proposed that the use of virtual-reality (VR) activities during treatment sessions can improve upper extremity function following stroke as it is motivating, challenging, offers external feedback that may facilitate motor learning, and allows for the "high-intensity, repetitious practice necessary to drive recovery". Coupling bilateral simultaneous upper extremity movement and virtual-reality activities is the Bimanual Arm Trainer (BAT), a non-powered mechanical device by which the non-paretic upper extremity moves the paretic arm. The purpose of this study is to determine the effectiveness of the Bimanual Arm Trainer (BAT) compared to traditional occupational therapy treatment sessions as these relate to upper extremity functional return following stroke, as measured by scores on the Action Research Arm Test (ARAT) and Upper Extremity Fugl-Meyer Assessment (UE-FMA) measures. The investigators plan to use retrospective data for a pre-implementation group, comparing this data to prospectively collected post-implementation data. ARAT scores are routinely collected and will be used for comparison between groups. UE-FMA measures are commonly used in this area of research, and will be taken to provide additional context for the post-implementation group.
Read the detailed description
The medical charts of patients with a diagnosis of stroke will be reviewed retroactively to determine if there is a significant difference in improvement of upper extremity function (measured by ARAT and UE-FMA scores) following traditional occupational therapy services vs. use of the bimanual arm trainer. Medical charts of patients from November 2019 to November 2020 will be reviewed to obtain ARAT scores of patients who received traditional occupational therapy services. The Bimanual Arm Trainer was obtained in April 23, 2020; however, due to the pandemic, it was not able to be utilized until November 13, 2020. Patients from Review Board-approval onward will be assessed for ARAT and FMA-UE scores while using the device.
Duration: A minimum of 10 minutes for 3 separate sessions with Occupational Therapy for BAT participation. 15-30 minutes with Occupational Therapy (OT) within 3 days of admission and discharge for ARAT administration. The investigators anticipate that without mixed retrospective/prospective collection sample (post intervention application), the investigators will be able to reach the investigators' target participant number in 12 months after approval.
This study will not use a placebo or non-treatment group. The investigators will compare data retrospectively to patients who received standard care prior to the BAT being accessible within the investigators' rehabilitation department. Once the BAT was obtained and training occurred on the unit among staff members, the device was considered standard of care treatment to qualifying stroke patients; therefore, there is not a placebo group in the prospective portion of this study. Appropriate patient's will receive treatment sessions on the BAT regardless of participation in this study.
- Conditions
- Stroke, Acute, Upper Extremity Paresis
- Being tested
- Bimanual Arm Trainer
- Keywords
- rehabilitation, Occupational Therapists, Physical Therapists
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimanual Arm TrainerDevice
tabletop/desktop device that couples bilateral simultaneous upper extremity movement with virtual reality games or activities via computer monitor
| Study group | Role | What they receive |
|---|---|---|
| Traditional Occupational Therapy | participants receiving traditional occupational therapy treatments and interventions provided in the inpatient rehabilitation setting. This includes, but is not limited to , therapeutic activity, therapeutic exercise, neuromuscular re-education. This group is retrospectively collected, and will not include participants who had access to the BAT. | |
| Bimanual Arm Trainer | Participants who are prospectively enrolled, who are appropriate for BAT use. Participants will receive additional traditional occupational therapy interventions, as deemed appropriate by treating therapists. Receives: Device: Bimanual Arm Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Action Research Arm Test score
a standardized tool that assesses UE functional limitations based off of 19 action-based items. Scores range from a minimum of 0 to a maximum of 57 points, with higher scores reflecting greater upper extremity functioning.
Measured: Within 72 hours of admission and up to 72 hours of discharge for all participants
Secondary outcomes (1)
Change in Upper Extremity Fugl-Meyer Assessment score
The UE-FMA is a body-functional level assessment of upper arm movement and sensation. Scores range from a minimum of o to a maximum of 66 points, with higher scores reflecting greater control of movement.
Measured: Within 72 hours of admission and Up to 72 hours of discharge for all participants in the BAT group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 May 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Babunovic, DPT, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106595
- Sponsor's protocol ID
- IRB00303045
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Bimanual Arm Training Device in Acute Inpatient Stroke Rehabilitation, a Pre-post Cohort Study
- ClinicalTrials.gov ID
- NCT05106595
- Acronym / sponsor ID
- IRB00303045
- Conditions
- Stroke, Acute, Upper Extremity Paresis
- Keywords
- rehabilitation, Occupational Therapists, Physical Therapists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 4 Nov 2021 (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.
Recent studies have shown that completing bilateral simultaneous movements during upper extremity practice may result in facilitation of coactivation and interhemispheric activation of both the ipsilesional and contralesional brain areas, with one limb entraining the other and enabling the limbs to function as a unit. Other research has proposed that the use of virtual-reality (VR) activities during treatment sessions can improve upper extremity function following stroke as it is motivating, challenging, offers external feedback that may facilitate motor learning, and allows for the "high-intensity, repetitious practice necessary to drive recovery". Coupling bilateral simultaneous upper extremity movement and virtual-reality activities is the Bimanual Arm Trainer (BAT), a non-powered mechanical device by which the non-paretic upper extremity moves the paretic arm. The purpose of this study is to determine the effectiveness of the Bimanual Arm Trainer (BAT) compared to traditional occupational therapy treatment sessions as these relate to upper extremity functional return following stroke, as measured by scores on the Action Research Arm Test (ARAT) and Upper Extremity Fugl-Meyer Assessment (UE-FMA) measures. The investigators plan to use retrospective data for a pre-implementation group, comparing this data to prospectively collected post-implementation data. ARAT scores are routinely collected and will be used for comparison between groups. UE-FMA measures are commonly used in this area of research, and will be taken to provide additional context for the post-implementation group.
Detailed description
The medical charts of patients with a diagnosis of stroke will be reviewed retroactively to determine if there is a significant difference in improvement of upper extremity function (measured by ARAT and UE-FMA scores) following traditional occupational therapy services vs. use of the bimanual arm trainer. Medical charts of patients from November 2019 to November 2020 will be reviewed to obtain ARAT scores of patients who received traditional occupational therapy services. The Bimanual Arm Trainer was obtained in April 23, 2020; however, due to the pandemic, it was not able to be utilized until November 13, 2020. Patients from Review Board-approval onward will be assessed for ARAT and FMA-UE scores while using the device.
Duration: A minimum of 10 minutes for 3 separate sessions with Occupational Therapy for BAT participation. 15-30 minutes with Occupational Therapy (OT) within 3 days of admission and discharge for ARAT administration. The investigators anticipate that without mixed retrospective/prospective collection sample (post intervention application), the investigators will be able to reach the investigators' target participant number in 12 months after approval.
This study will not use a placebo or non-treatment group. The investigators will compare data retrospectively to patients who received standard care prior to the BAT being accessible within the investigators' rehabilitation department. Once the BAT was obtained and training occurred on the unit among staff members, the device was considered standard of care treatment to qualifying stroke patients; therefore, there is not a placebo group in the prospective portion of this study. Appropriate patient's will receive treatment sessions on the BAT regardless of participation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Occupational Therapy | – | –participants receiving traditional occupational therapy treatments and interventions provided in the inpatient rehabilitation setting. This includes, but is not limited to , therapeutic activity, therapeutic exercise, neuromuscular re-education. This group is retrospectively collected, and will not include participants who had access to the BAT. |
| Bimanual Arm Trainer | – | Device: Bimanual Arm TrainerParticipants who are prospectively enrolled, who are appropriate for BAT use. Participants will receive additional traditional occupational therapy interventions, as deemed appropriate by treating therapists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with acute or sub-acute stroke, with upper extremity paresis, admitted to an Acute Inpatient Rehab (IRF/AIR) unit.
Key inclusion criteria (3 listed)
- Diagnosis of acute stroke.
- Score of <17 on admission ARAT.
- Participation ≥ 3 BAT training sessions.
Key exclusion criteria (4 listed)
- Impaired cognition impacting ability to participate in virtual reality system
- Pain resulting in poor tolerance of range of motion.
- Impaired sitting balance or poor tolerance of sitting in upright posture in chair without armrests.
- Spasticity in the affected upper extremity Modified Ashworth Scale (MAS) of 3 or greater.
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 |
|---|---|---|
| Bimanual Arm Trainertabletop/desktop device that couples bilateral simultaneous upper extremity movement with virtual reality games or activities via computer monitor | Device | Bimanual Arm Trainer |
Primary outcome
Change in Action Research Arm Test score
Time frame: Within 72 hours of admission and up to 72 hours of discharge for all participants
a standardized tool that assesses UE functional limitations based off of 19 action-based items. Scores range from a minimum of 0 to a maximum of 57 points, with higher scores reflecting greater upper extremity functioning.
1 secondary outcome
Change in Upper Extremity Fugl-Meyer Assessment score
Time frame: Within 72 hours of admission and Up to 72 hours of discharge for all participants in the BAT group
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 18 Nov 2023.
- 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.
Matthew Babunovic, DPT principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Upper Extremity Paresis, run by Johns Hopkins University 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 3 inclusion and 4 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 18 Nov 2023. 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?
Change in Action Research Arm Test score (time frame: Within 72 hours of admission and up to 72 hours of discharge for all participants). 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 18 Nov 2023.