Arm Motor Control on Bi and Uni ADLs

Not Applicable

Terminated

• Conditions: Cerebral Palsy; Stroke; Peripheral Neuropathy; Spinal Cord Injuries
• Interventions: Device: Bilateral assessment robots (BiAS)

• Registration Number: NCT02778529
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-20
• Status Verified: 2023-09
• Primary Completion: 2023-09
• Study Completion: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

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Exclusion Criteria

• The inability to perform at least some aspects of ADL tasks such as drinking, pouring, pinching, and grasping.
• Severe spasticity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upper Limb Assessment on ADLs	Bilateral assessment robots (BiAS)	Bilateral assessment robots (BiAS) Evaluate upper limb kinematics of Stroke, Amputees, SCI, Cerebral Palsy and Health Subjects will be assessed as they complete unilateral and bilateral activities of daily living. Subjects will complete exercises in 1 session

Primary Outcome Measures

Name	Time	Method
Movement Time	up to 1 week	time to complete a task
Interlimb Coordination	up to 1 week	Kinematic Variables of Movement Overlap and Phase Difference

Secondary Outcome Measures

Name	Time	Method
Movement Smoothness	up to 1 week	Jerkiness on a task
Sensory Nerve Deficits	up to 1 week	Pin and Prick assessment
Gross Finger Dexterity	up to 1 week	Box and Block assessment
Grip strength	up to 1 week	Grip Dynamometer measurement of strength

Trial Locations

Locations (1)

Penn Medicine Rittenhouse; 🇺🇸 Philadelphia, Pennsylvania, United States