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Clinical Trials/NCT02778529
NCT02778529
Terminated
N/A

Insights Into Impaired Arm Motor Control on Bilateral and Unilateral Functional Activities After Injury: A Kinematic Study

University of Pennsylvania1 site in 1 country18 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Pennsylvania
Enrollment
18
Locations
1
Primary Endpoint
Interlimb Coordination
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
September 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Interlimb Coordination

Time Frame: up to 1 week

Kinematic Variables of Movement Overlap and Phase Difference

Movement Time

Time Frame: up to 1 week

time to complete a task

Secondary Outcomes

  • Sensory Nerve Deficits(up to 1 week)
  • Gross Finger Dexterity(up to 1 week)
  • Grip strength(up to 1 week)
  • Movement Smoothness(up to 1 week)

Study Sites (1)

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