StrokeBiADLERNCT02882646
Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy
A study testing Bi-ADLER in people with Stroke and Cerebral Palsy, run by University of Pennsylvania at 1 site in United States.
Trial summary
In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the frequent strategy used over bilateral ones. However, the clinical need for bilateral training is supported by evidence that shows that unilateral training of the impaired limb does not automatically restore bimanual… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebral Palsy
- What is being tested?
- Bi-ADLER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2021
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A:
- Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
- Healthy persons over the age of 18 with no upper limb impairment.
- Part B:
- Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
Who cannot join
- The Montreal Cognitive Assessment (MoCA) to each study participant. After the administration of the MoCA, the PI and research team member will use their to expertise and discretion to determine whether the participant scored well enough on particular components of the MOCA that are of particular concern to this study, e.g. visuospatial acuity and concentration.
- Participants must be able to sit upright for 2 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study.
- Participants enrolled in Part B cannot currently be receiving rehabilitation.
- Participants cannot have received Botox injections within the past 3 months.
- Participants cannot be suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity or any other neuromuscular disease.
- If a participant is experiencing greater than mild pain, and/or the PI determines that the participant should no longer continue working with the novel therapy devices, the study will be stopped.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146
About this study
In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the frequent strategy used over bilateral ones. However, the clinical need for bilateral training is supported by evidence that shows that unilateral training of the impaired limb does not automatically restore bimanual coordination and function. Increased focused is needed on developing more robot-assisted therapy that can train the impaired arm bilaterally and unilaterally. Controlling these robots is often difficult and requires a better understanding of the coupling effects of the left and right hand before and after a stroke. There is a need to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual movements as well as symmetry as well as asymmetry in context of human bimanual actions along with the intermanual division of labor in various ADL tasks. This study focuses on bilateral training and the use of bio-inspired control algorithms to understand impairment and recovery on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will be evaluated by a member of the research team and asked to perform a battery of tasks to test the viability and usability of a bilateral robot system called BiADLER, which allows patients to complete daily tasks with varying levels of assistance to adapt task performance to each individual subject's performance. Subjects will to provide feedback to the researchers on their observations and thoughts about the therapy devices.
Read the detailed description
Subjects may be video-taped or photographed in any of the following sessions.
Part A: Participation in this part of the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: A member of the research team will evaluate the subjects' affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block, and grip strength using a dynamometer, etc.
2b) Break: Subjects will be given a 15 minute break.
2c) Subjects will be asked to use the Bilateral Activities of Daily Living Exercise Robot (Bi-ADLER) for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (drawing ovals, standard ADL tasks like pouring, reaching, drinking etc). A total of three trials (each 1 min or less) will be done for each evaluation task and a 5 min break will be given after two tasks. His/her kinematic data while performing the corresponding evaluation task will be compared against the healthy baseline to predict their level of impairment. During this portion of the experiment, the controller will provide no assistance to the patient. This will take a total of about 25-30 mins. After the the controller will be engaged and assistance will be provided to patients for performing the same battery of tasks completed in the first half of this session. This will take another 25-30 mins.
Part B: For subjects invited to participate in Part B of the study - only low to mid functioning Cerebral Palsy (CP) and stroke survivors are eligible -participation in this part of the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: If subjects are only participating in Part B of the study, at their first visit, a member of the research team will evaluate their affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block and grip strength using a dynamometer, etc. If a study subject participated in Part A, they will not be reevaluated by a therapist as long as evaluation was done within a month of Part B.
2b) Break: Subjects will be given a 15 minute break. 2c) Bi-ADLER training with the robot for 50-60 minutes. In this part of the protocol, the subject will come to the lab for about 10-12 sessions. In each session, the subject performs different activities of daily Living tasks (like pouring, drinking etc) on the Bi-ADLER for about 50-60 mins with a 5 min break every15 mins. This part is contingent on the subject having completed Part A of the protocol. During the final session (between 10th - 12th session), the same battery of tasks as in Part A will be performed by the subject. There will also be a clinical evaluation at the end of that session to evaluate clinical scores.
- Post-Study Assessment: After their last session, a certified therapist will evaluate the participants' affected arm and assess their ability to use it.
- Conditions
- Stroke, Cerebral Palsy
- Being tested
- Bi-ADLER
- Keywords
- stroke, cerebral palsy, rehabilitation, robotics, therapy, bilateral
- Medical subject headings
- Stroke, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-ADLERDevice
Subjects will be asked to use the Bi-ADLER for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (creating ovals, standard ADL tasks like pouring, reaching, drinking etc).
| Study group | Role | What they receive |
|---|---|---|
| Stroke/CP survivors & healthy subjects | Experimental | Part A: Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. Healthy persons over the age of 18 with no upper limb impairment.
Part B: Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. All will be asked to use the Bi-ADLER system. Receives: Device: Bi-ADLER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Control as assessed by Fugl-Meyer assessment
Fugl-Meyer assessment will be performed by a physical therapist and will assess motor control of the subject.
Measured: The Fugl-Meyer assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Motor Control as assessed by Box and Block
The Box and Block assessment will be performed by a member of the study team and will assess motor control by how many blocks that subject is able to move over a barrier.
Measured: The Box and Block assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Motor Control as assessed by Grip Strength
Grip strength will be measured by a dynamometer which clinically assesses motor control.
Measured: The Grip Strength assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Bimanual activity quality as assessed by Task Completion Time
Task Completion Time (TCT): TCT is defined as the time in seconds that it takes to complete the task from initial button press to the final button press.
Measured: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Bimanual activity quality as assessed by Euclidean Distance
Euclidean Distance : Relative distance (Euclidean) between the wrists positions of the left (non-dominant) and right (dominant) hands.
Measured: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Bimanual activity quality as assessed by Ovalization Index
Ovalization Index : An Ovalization Index (OI) is defined to quantify the occurrence of lateral deviation when continuously drawing a straight vertical line. The strength of any bimanual coupling/interference effect was signaled by an increased OI value in the Non-congruent condition compared to the Congruent condition.
Measured: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Secondary outcomes (3)
Phase Difference (PD)
PD describes the lag between the two limbs as a measure of the synchronization of the two arms. Thus, a positive PD signifies that the dominant arm was leading in the task.
Measured: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Movement Overlap (MO)
MO is defined as the time when both hands were in motion as a percentage of total TCT
Measured: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Mean Speed Smoothness
Smoothness was calculated by counting the number of peaks in the velocity profile. The greater the value, the poorer the quality of the movement.
Measured: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: Permanently suspended due to equipment issues
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 University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle J Johnson, PhD, Principal investigator, Penn Medicine Rittenhouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882646
- Sponsor's protocol ID
- 823898
- Acronym
- BiADLER
- Status last verified
- Oct 2024
- First submitted
- 22 Jul 2016
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy
- ClinicalTrials.gov ID
- NCT02882646
- Acronym / sponsor ID
- BiADLER / 823898
- Conditions
- Stroke, Cerebral Palsy
- Keywords
- stroke, cerebral palsy, rehabilitation, robotics, therapy, bilateral
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Permanently suspended due to equipment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 30 Aug 2016 (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.
In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the frequent strategy used over bilateral ones. However, the clinical need for bilateral training is supported by evidence that shows that unilateral training of the impaired limb does not automatically restore bimanual coordination and function. Increased focused is needed on developing more robot-assisted therapy that can train the impaired arm bilaterally and unilaterally. Controlling these robots is often difficult and requires a better understanding of the coupling effects of the left and right hand before and after a stroke. There is a need to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual movements as well as symmetry as well as asymmetry in context of human bimanual actions along with the intermanual division of labor in various ADL tasks. This study focuses on bilateral training and the use of bio-inspired control algorithms to understand impairment and recovery on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will be evaluated by a member of the research team and asked to perform a battery of tasks to test the viability and usability of a bilateral robot system called BiADLER, which allows patients to complete daily tasks with varying levels of assistance to adapt task performance to each individual subject's performance. Subjects will to provide feedback to the researchers on their observations and thoughts about the therapy devices.
Detailed description
Subjects may be video-taped or photographed in any of the following sessions.
Part A: Participation in this part of the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: A member of the research team will evaluate the subjects' affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block, and grip strength using a dynamometer, etc.
2b) Break: Subjects will be given a 15 minute break.
2c) Subjects will be asked to use the Bilateral Activities of Daily Living Exercise Robot (Bi-ADLER) for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (drawing ovals, standard ADL tasks like pouring, reaching, drinking etc). A total of three trials (each 1 min or less) will be done for each evaluation task and a 5 min break will be given after two tasks. His/her kinematic data while performing the corresponding evaluation task will be compared against the healthy baseline to predict their level of impairment. During this portion of the experiment, the controller will provide no assistance to the patient. This will take a total of about 25-30 mins. After the the controller will be engaged and assistance will be provided to patients for performing the same battery of tasks completed in the first half of this session. This will take another 25-30 mins.
Part B: For subjects invited to participate in Part B of the study - only low to mid functioning Cerebral Palsy (CP) and stroke survivors are eligible -participation in this part of the study will include the following steps:
- Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: If subjects are only participating in Part B of the study, at their first visit, a member of the research team will evaluate their affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block and grip strength using a dynamometer, etc. If a study subject participated in Part A, they will not be reevaluated by a therapist as long as evaluation was done within a month of Part B.
2b) Break: Subjects will be given a 15 minute break. 2c) Bi-ADLER training with the robot for 50-60 minutes. In this part of the protocol, the subject will come to the lab for about 10-12 sessions. In each session, the subject performs different activities of daily Living tasks (like pouring, drinking etc) on the Bi-ADLER for about 50-60 mins with a 5 min break every15 mins. This part is contingent on the subject having completed Part A of the protocol. During the final session (between 10th - 12th session), the same battery of tasks as in Part A will be performed by the subject. There will also be a clinical evaluation at the end of that session to evaluate clinical scores.
- Post-Study Assessment: After their last session, a certified therapist will evaluate the participants' affected arm and assess their ability to use it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke/CP survivors & healthy subjects | Experimental | Device: Bi-ADLERPart A: Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. Healthy persons over the age of 18 with no upper limb impairment. Part B: Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. All will be asked to use the Bi-ADLER system. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
- Healthy persons over the age of 18 with no upper limb impairment.
- Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
Key exclusion criteria (6 listed)
- The Montreal Cognitive Assessment (MoCA) to each study participant. After the administration of the MoCA, the PI and research team member will use their to expertise and discretion to determine whether the participant scored well enough on particular components of the MOCA that are of particular concern to this study, e.g. visuospatial acuity and concentration.
- Participants must be able to sit upright for 2 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study.
- Participants enrolled in Part B cannot currently be receiving rehabilitation.
- Participants cannot have received Botox injections within the past 3 months.
- Participants cannot be suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity or any other neuromuscular 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 |
|---|---|---|
| Bi-ADLERSubjects will be asked to use the Bi-ADLER for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (creating ovals, standard ADL tasks like pouring, reaching, drinking etc). | Device | Stroke/CP survivors & healthy subjects |
Primary outcome
Motor Control as assessed by Fugl-Meyer assessment
Time frame: The Fugl-Meyer assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Fugl-Meyer assessment will be performed by a physical therapist and will assess motor control of the subject.
Motor Control as assessed by Box and Block
Time frame: The Box and Block assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
The Box and Block assessment will be performed by a member of the study team and will assess motor control by how many blocks that subject is able to move over a barrier.
Motor Control as assessed by Grip Strength
Time frame: The Grip Strength assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control
Grip strength will be measured by a dynamometer which clinically assesses motor control.
Bimanual activity quality as assessed by Task Completion Time
Time frame: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Task Completion Time (TCT): TCT is defined as the time in seconds that it takes to complete the task from initial button press to the final button press.
Bimanual activity quality as assessed by Euclidean Distance
Time frame: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Euclidean Distance : Relative distance (Euclidean) between the wrists positions of the left (non-dominant) and right (dominant) hands.
Bimanual activity quality as assessed by Ovalization Index
Time frame: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Ovalization Index : An Ovalization Index (OI) is defined to quantify the occurrence of lateral deviation when continuously drawing a straight vertical line. The strength of any bimanual coupling/interference effect was signaled by an increased OI value in the Non-congruent condition compared to the Congruent condition.
3 secondary outcomes
Phase Difference (PD)
Time frame: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Movement Overlap (MO)
Time frame: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Mean Speed Smoothness
Time frame: In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Michelle J Johnson, PhD principal investigator
Penn Medicine Rittenhouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-ADLER in people with Stroke and Cerebral Palsy, run by University of Pennsylvania 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 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: withdrawn, as of the sponsor's last update on 8 Oct 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 withdrawn before enrolling participants, so there are no results.
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?
Motor Control as assessed by Fugl-Meyer assessment (time frame: The Fugl-Meyer assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control). The study lists 6 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 8 Oct 2024.