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

5 oktober 2015 bijgewerkt door: Michael Ellis, Northwestern University
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

38

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60611
        • Department of Physical Therapy and Human Movement Sciences

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: Abduction Loading
The intervention for the active comparison group entails practicing reaching utilizing the robotic device, ACT3D, with only abduction loading.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Peak Endpoint Reaching Velocity
Tijdsspanne: 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)
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.
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)
Change in Reaching Work Area
Tijdsspanne: 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)
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.
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fugl-Meyer Motor Assessment
Tijdsspanne: 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)
Qualitative and clinical assessment of general motor impairment of arm following stroke.
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)
Rancho Los Amigos Functional Test for the Hemiparetic Upper Extremity
Tijdsspanne: 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)
Qualitative and clinical assessment of activity limitation (function) of the arm following stroke.
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)
Stroke Impact Scale
Tijdsspanne: 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)
Structured interview to assess all domains of the ICF (International Classification of Functioning, Disability and Health) in individuals following stroke.
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)
Motor Activity Log
Tijdsspanne: 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)
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.
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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Northwestern University

Medewerkers

U.S. Department of Education

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2012

Primaire voltooiing (Werkelijk)

1 juli 2015

Studie voltooiing (Werkelijk)

1 juli 2015

Studieregistratiedata

Eerst ingediend

29 februari 2012

Eerst ingediend dat voldeed aan de QC-criteria

5 maart 2012

Eerst geplaatst (Schatting)

8 maart 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

6 oktober 2015

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2015

Laatst geverifieerd

1 oktober 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H133G110245

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