The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Northwestern University
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Michael Ellis, Northwestern University
ClinicalTrials.gov Identifier:
NCT01548781
First received: February 29, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Impairment-based robotic intervention for reaching function

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Peak Endpoint Reaching Velocity [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    Qualitative and clinical assessment of general motor impairment of arm following stroke.

  • Rancho Los Amigos Functional Test for the Hemiparetic Upper Extremity [ 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) ] [ Designated as safety issue: No ]
    Qualitative and clinical assessment of activity limitation (function) of the arm following stroke.

  • Stroke Impact Scale [ 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) ] [ Designated as safety issue: No ]
    Structured interview to assess all domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke.

  • Motor Activity Log [ 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viscous Resistance & Abduction Loading
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.
Behavioral: Impairment-based robotic intervention for reaching function
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.
Active Comparator: Abduction Loading
The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
Behavioral: Impairment-based robotic intervention for reaching function
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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548781

Contacts
Contact: Michael D Ellis, PT, DPT 3125034435 m-ellis@northwestern.edu
Contact: Bradley G Holubar, MS 3125034434 b-holubar@northwestern.edu

Locations
United States, Illinois
Department of Physical Therapy and Human Movement Sciences Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael D Ellis, PT, DPT    312-503-4435    m-ellis@northwestern.edu   
Principal Investigator: Michael D Ellis, PT, PhD         
Sub-Investigator: Ana Maria Acosta, PhD         
Sub-Investigator: Julius PA Dewald, PT, PhD         
Sponsors and Collaborators
Northwestern University
U.S. Department of Education
Investigators
Principal Investigator: Michael D Ellis, PT, DPT Northwestern University
  More Information

Additional Information:
Publications:
Responsible Party: Michael Ellis, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01548781     History of Changes
Other Study ID Numbers: H133G110245
Study First Received: February 29, 2012
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
arm
strength
coordination
physical therapy
robotics
stroke
synergy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014