The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impairment-based robotic intervention for reaching function
Sponsored by

About this trial
This is an interventional basic science trial for Stroke focused on measuring arm, strength, coordination, physical therapy, robotics, stroke, synergy
Eligibility Criteria
Inclusion Criteria:
- Paresis confined to one side, with substantial motor impairment of the upper limb
- Absence of motor impairment in the unimpaired limb
- Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment, changes in management of hypertension)
- Absence of any acute or chronic painful condition in the upper extremities or spine
- Absence of hemineglect
- Capacity to provide informed consent.
Sites / Locations
- Department of Physical Therapy and Human Movement Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Viscous Resistance & Abduction Loading
Abduction Loading
Arm Description
The intervention for the experimental group entails practicing reaching utilizing the robotic device, ACT3D, with the experimental element of horizontal viscosity in combination with abduction loading.
The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
Outcomes
Primary Outcome Measures
Change in Peak Endpoint Reaching Velocity
We will quantify peak endpoint reaching velocity with a robotic device, ACT3D, when a participant with stroke reaches as fast as they can toward an outward target under various abduction (gravity) loading conditions. This measure will serve as the primary measure for changes in dynamic multi-joint strength.
Change in Reaching Work Area
We will quantify total reaching work area (combined shoulder and elbow range of motion) with a robotic device, ACT3D, under various abduction (gravity) loading conditions. This measure will serve as the primary measure changes in dynamic multi-joint range of motion.
Secondary Outcome Measures
Fugl-Meyer Motor Assessment
Qualitative and clinical assessment of general motor impairment of arm following stroke.
Rancho Los Amigos Functional Test for the Hemiparetic Upper Extremity
Qualitative and clinical assessment of activity limitation (function) of the arm following stroke.
Stroke Impact Scale
Structured interview to assess all domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke.
Motor Activity Log
Structured interview assessing the individual with stroke's perception of difficulty in the context of arm function during a variety of activities of daily living.
Full Information
NCT ID
NCT01548781
First Posted
February 29, 2012
Last Updated
October 5, 2015
Sponsor
Northwestern University
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT01548781
Brief Title
The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke
Official Title
The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Disturbances in movement coordination are the least well understood but often the most debilitating with respect to functional recovery following stroke. These deficits in coordination are expressed in the form of abnormal muscle synergies and result in limited and stereotypic movement patterns that are functionally disabling. The result of these constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an individual with stroke when they lift up the weight of the impaired arm against gravity. The investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated research grant, has shown that the abnormal synergy between shoulder abduction and elbow flexion can be significantly reduced thus increasing total reaching range of motion in individuals with severe stroke. The previous work established progressive abduction loading as a key element to the rehabilitation of reaching. Although individuals with severe stroke benefited from the investigators previous work, residual flexion synergy continued to hinder normal arm function in most participants with severe stroke. This study will utilize the ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate resistance to reaching while accounting for the known benefits of progressive abduction loading. The investigators propose to randomize forty participants with severe stroke into two closely related interventions. The groups will both practice reaching under abduction loading, however, the experimental group will also move against resistance while reaching. Rigorous and quantitative investigation of therapeutic elements such as resistance to reaching and progressive abduction loading is only possible with a device such as the ACT3D. the investigators will be able to standardize the delivery of each intervention using kinematic and kinetic parameters, which will allow for a clear identification of the therapeutic effect of resistance to reaching. the investigators hypothesize that resistance to reaching in combination with progressive abduction loading will further increase dynamic multi-joint strength, increase total reaching range of motion, and increase arm function thus enhancing actual amount of use of the arm, participation in life roles, and quality of life in individuals with severe stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
arm, strength, coordination, physical therapy, robotics, stroke, synergy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viscous Resistance & Abduction Loading
Arm Type
Experimental
Arm Description
The intervention for the experimental group entails practicing reaching utilizing the robotic device, ACT3D, with the experimental element of horizontal viscosity in combination with abduction loading.
Arm Title
Abduction Loading
Arm Type
Active Comparator
Arm Description
The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
Intervention Type
Behavioral
Intervention Name(s)
Impairment-based robotic intervention for reaching function
Intervention Description
All participants will undergo 8 weeks of reaching practice in the ACT3D. Frequency and duration will be matched at three 1.5-hour sessions per week. All reaching practice will include abduction (gravity) loading standardized to the participant's motor abilities. The experimental group intervention will also include a horizontal viscous resistant element similar to pushing the arm through molasses.
Primary Outcome Measure Information:
Title
Change in Peak Endpoint Reaching Velocity
Description
We will quantify peak endpoint reaching velocity with a robotic device, ACT3D, when a participant with stroke reaches as fast as they can toward an outward target under various abduction (gravity) loading conditions. This measure will serve as the primary measure for changes in dynamic multi-joint strength.
Time Frame
Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
Title
Change in Reaching Work Area
Description
We will quantify total reaching work area (combined shoulder and elbow range of motion) with a robotic device, ACT3D, under various abduction (gravity) loading conditions. This measure will serve as the primary measure changes in dynamic multi-joint range of motion.
Time Frame
Pre-test (Within one week prior to the onset of the intervention) to post-test (Within one week of the final intervention session) & post-test to 3-month follow-up (In the twelfth or thirteenth week following the last intervention session)
Secondary Outcome Measure Information:
Title
Fugl-Meyer Motor Assessment
Description
Qualitative and clinical assessment of general motor impairment of arm following stroke.
Time Frame
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Title
Rancho Los Amigos Functional Test for the Hemiparetic Upper Extremity
Description
Qualitative and clinical assessment of activity limitation (function) of the arm following stroke.
Time Frame
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Title
Stroke Impact Scale
Description
Structured interview to assess all domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke.
Time Frame
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
Title
Motor Activity Log
Description
Structured interview assessing the individual with stroke's perception of difficulty in the context of arm function during a variety of activities of daily living.
Time Frame
Pre-(Within one week prior to the onset of the intervention), post-(Within one week of the final intervention session), and 3-month follow up (In the twelfth or thirteenth week following the last intervention session)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Paresis confined to one side, with substantial motor impairment of the upper limb
Absence of motor impairment in the unimpaired limb
Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment, changes in management of hypertension)
Absence of any acute or chronic painful condition in the upper extremities or spine
Absence of hemineglect
Capacity to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Ellis, PT, DPT
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy and Human Movement Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19454622
Citation
Ellis MD, Sukal-Moulton T, Dewald JP. Progressive shoulder abduction loading is a crucial element of arm rehabilitation in chronic stroke. Neurorehabil Neural Repair. 2009 Oct;23(8):862-9. doi: 10.1177/1545968309332927. Epub 2009 May 19.
Results Reference
background
PubMed Identifier
18326888
Citation
Ellis MD, Sukal T, DeMott T, Dewald JP. Augmenting clinical evaluation of hemiparetic arm movement with a laboratory-based quantitative measurement of kinematics as a function of limb loading. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):321-9. doi: 10.1177/1545968307313509. Epub 2008 Mar 8.
Results Reference
background
PubMed Identifier
17634933
Citation
Sukal TM, Ellis MD, Dewald JP. Shoulder abduction-induced reductions in reaching work area following hemiparetic stroke: neuroscientific implications. Exp Brain Res. 2007 Nov;183(2):215-23. doi: 10.1007/s00221-007-1029-6. Epub 2007 Jul 20.
Results Reference
background
PubMed Identifier
16924488
Citation
Ellis MD, Acosta AM, Yao J, Dewald JP. Position-dependent torque coupling and associated muscle activation in the hemiparetic upper extremity. Exp Brain Res. 2007 Feb;176(4):594-602. doi: 10.1007/s00221-006-0637-x. Epub 2006 Aug 22.
Results Reference
background
PubMed Identifier
15880629
Citation
Ellis MD, Holubar BG, Acosta AM, Beer RF, Dewald JP. Modifiability of abnormal isometric elbow and shoulder joint torque coupling after stroke. Muscle Nerve. 2005 Aug;32(2):170-8. doi: 10.1002/mus.20343.
Results Reference
background
PubMed Identifier
29515514
Citation
Ellis MD, Carmona C, Drogos J, Dewald JPA. Progressive Abduction Loading Therapy with Horizontal-Plane Viscous Resistance Targeting Weakness and Flexion Synergy to Treat Upper Limb Function in Chronic Hemiparetic Stroke: A Randomized Clinical Trial. Front Neurol. 2018 Feb 19;9:71. doi: 10.3389/fneur.2018.00071. eCollection 2018.
Results Reference
derived
Links:
URL
http://www.feinberg.northwestern.edu/nupthms/
Description
Northwestern University, Feinberg School of Medicine, Department of Physical Therapy and Human Movement Sciences
Learn more about this trial
The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke
We'll reach out to this number within 24 hrs