Clinical trial NCT02778529: Arm Motor Control on Bi and Uni ADLs
Official title: Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Peripheral Neuropathy
Spinal Cord Injuries
Cerebral Palsy
Keywords: stroke
amputees
spinal cord injuries
cerebral palsy
robotics
rehabilitation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interlimb Coordination
timeFrame: up to 1 week
measure: Movement Time
timeFrame: up to 1 week
Secondary outcomes:
measure: Gross Finger Dexterity
timeFrame: up to 1 week
measure: Sensory Nerve Deficits
timeFrame: up to 1 week
measure: Grip strength
timeFrame: up to 1 week
measure: Movement Smoothness
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
Study officials:
affiliation: Penn Medicine Rittenhouse
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dimwamwa E, Johnson MJ. Kinematic analysis of unilateral and bilateral drinking task after brain and periphery injuries. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:4558-61. doi: 10.1109/EMBC.2015.7319408.
citation: Johnson MJ, Wang S, Bai P, Strachota E, Tchekanov G, Melbye J, McGuire J. Bilateral assessment of functional tasks for robot-assisted therapy applications. Med Biol Eng Comput. 2011 Oct;49(10):1157-71. doi: 10.1007/s11517-011-0817-0. Epub 2011 Sep 1.