Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 1/13/2019 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
| Contact: | Kristine A Lima, BS |
| Email: | kristine.lima@uphs.upenn.edu |
| Phone: | 215-893-2679 |
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.
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.
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:
1) 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:
1) 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.
3) Post-Study Assessment: After their last session, a certified therapist will evaluate the
participants' affected arm and assess their ability to use it.
Part A: Participation in this part of the study will include the following steps:
1) 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:
1) 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.
3) Post-Study Assessment: After their last session, a certified therapist will evaluate the
participants' affected arm and assess their ability to use it.
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Click here to add this to my saved trials
