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Terminated

NCT Number: NCT02778529

Arm Motor Control on Bi and Uni ADLs

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.

Why the study stopped: Equipment Failure
Terminated

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Key information

Conditions

Stroke Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peripheral Neuropathy Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

About this study

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:

  • Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
  • 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.
  • Break: Subjects will be given a 15 minute break.
  • 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.
  • Video and photos may be collected to determine subject quality of ADL movement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral assessment robots (BiAS)

Device

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.

Primary outcomes

  1. Interlimb Coordination: Movement Overlap (MO)

    Time frame: 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.

  2. Movement Time

    Time frame: 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.

  3. Interlimb Coordination: Phase Difference (PD)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: BiAs

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
May 20, 2016
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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