Cerebral Palsy, Peripheral Neuropathy, Spinal Cord Injuries, Stroke
Conditions
Keywords
stroke, amputees, spinal cord injuries, cerebral palsy, robotics, rehabilitation
Brief summary
This study is being performed to assess how certain chronic disabilities - stroke, upper extremity (UE) amputation, spinal cord injuries (SCI), cerebral palsy (CP) - differ from healthy subjects in their ability to perform ADLs. By studying the kinematics of the respective cohort of study participants as they are assessed performing common activities of daily living (ADLS), the investigators research team aims to better understand how impaired neural pathways, and pathways that have been impaired at various points along the pathway, deleteriously affect ADLs in patients with differing long-term disabilities.
Detailed description
Cross-sectional study comparing bilateral ADL activities for stroke survivors, SCI paraplegics, UE amputees, adults with CP, and healthy controls. The study participants will perform 4 ADL tasks with the BiAS passive robots. From these tasks, the BiAS robots will provide information regarding position, velocity, distance, displacement, etc. This, along with video information provided by the 3D Kinect and EEG neuroheadset, will be used as the basis of the investigators data and aid in informing members of the research team on how the respective impairments affected upper limb kinematics on ADL tasks. Participation in the study will include the following steps: 1. Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present. 2. Pre-Assessments: A member of the research team will evaluate the subjects' upper extremity and assess their ability to use it. Subjects will be evaluated using a battery of assessments such as, but not limited to, the Box and Block, Pin and Prick, and grip strength using a dynamometer. 3. Break: Subjects will be given a 15 minute break. 4. BiAS passive robot system: Subjects will be introduced to the device and each wrist will be placed on to the end of each robot. As common therapy tasks are performed by the subject, the BiAS devices will collect the data along with the video from 3D Kinect, ECG gelled electrodes, and the EEG neuroheadset. After each of the 4 ADL activities, subjects will be asked about their level of exercise and discomfort, if any. After subjects finish all exercises with the BiAS, they will be thanked for their participation in the study. 5. Video and photos may be collected to determine subject quality of ADL movement.
Interventions
DEVICEBilateral assessment robots (BiAS)
The BiAS are two passive desktop robots that will be used in this study to measure right and left arm kinematics for 4 different groups of patients.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Study will include subjects 18 years of age or older from any of the below groups: * Stroke survivors, 3 months post event * Upper extremity amputees, 3 months post event * Cervical SCI (C-5 to C-7), 3 months post event * Cerebral palsy participants * Healthy participants
Exclusion criteria
* The inability to perform at least some aspects of ADL tasks such as drinking, pouring, pinching, and grasping. * Severe spasticity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interlimb Coordination: Movement Overlap (MO) | approximately 3 hours | Kinematic Variables of Movement Overlap. Movement Overlap (MO): MO is defined as the time when both hands were in motion as a percentage of total Task Completion Time. |
| Movement Time | approximately 3 hours | Time to completion (TCT) was defined for unimanual tasks and bimanual tasks - left arm and right arm; Two tasks were completed Drink and Pour. Shorter times means better performance. |
| Interlimb Coordination: Phase Difference (PD) | approximately 3 hours | Kinematic Variables of Phase Difference (PD). PD describes the lag between the two limbs as a measure of the synchronization of the two arms: dominant (less-impaired) phase less non-dominant (impaired) phase. Phase was calculated from the arctangent of the ratio of velocity to displacement. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichelle J Johnson, PhD
University of Pennsylvania
Participant flow
Pre-assignment details
Eighteen subjects participated in this study: five healthy subjects, four stroke subjects, two amputee subjects, and seven CP subject. Subjects were screened based on self-reports to ensure that they had functional ability in both hands. Furthermore, ischemic stroke survivors with a Fugl-Meyer score of no lower than 34 and amputee subjects with transradial amputation were included. The Institutional Review Board at the University of Pennsylvania approved this study
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 13 |
| other Total, other adverse events | 0 / 5 | 0 / 13 |
| serious Total, serious adverse events | 0 / 5 | 0 / 13 |
Outcome results
None listed