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 September 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: September 23, 2014
Last verified: September 2014

February 29, 2012
September 23, 2014
March 2012
October 2015   (final data collection date for primary outcome measure)
  • 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.
  • Peak Endpoint Reaching Velocity [ 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 ]
    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.
  • Reaching Work Area [ 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 ]
    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.
Complete list of historical versions of study NCT01548781 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke
The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Stroke
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.
  • 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.
    Intervention: Behavioral: Impairment-based robotic intervention for reaching function
  • Active Comparator: Abduction Loading
    The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
    Intervention: Behavioral: Impairment-based robotic intervention for reaching function

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
October 2015   (final data collection date for primary outcome measure)

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.
Both
21 Years to 85 Years
No
Contact: Michael D Ellis, PT, DPT 3125034435 m-ellis@northwestern.edu
Contact: Bradley G Holubar, MS 3125034434 b-holubar@northwestern.edu
United States
 
NCT01548781
H133G110245
No
Michael Ellis, Northwestern University
Northwestern University
U.S. Department of Education
Principal Investigator: Michael D Ellis, PT, DPT Northwestern University
Northwestern University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP