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Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

3 januari 2014 uppdaterad av: US Department of Veterans Affairs
The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study continues our investigation of the optimal timing, intensity, and duration of robot-assisted training to improve motor performance in patients with hemiplegia following stroke. These hypotheses will be tested: 1) subjects receiving robot-assisted upper limb therapy with MIME in the initial phase of recovery from stroke experience greater functional gains than a control group receiving additional conventional therapy of equal intensity and duration, 2) robot-assisted therapy results in a dose-dependent response, and 3) robot-assisted therapy promotes greater control of movement, greater recovery of strength, and greater reduction of co-contraction than the control intervention. Research Plan - A multi-site clinical trial is in progress at the Houston VA Medical Center (VAMC), the VA Greater Los Angeles Health Care System (GLAHCS), the VA Palo Alto Rehabilitation Research and Development Center (RR&DC), and the Central Texas Veterans Health Care System (CTVHCS). CTVHCS serves as the coordinating site. The RR&DC provides training and technical assistance for the other sites. Methods - Subjects with hemiparesis due to a stroke are randomly assigned to 3 groups. Group 1 receives 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Group 2 receives a total of 2 hours/day of robot-assisted therapy. Group 3 receives 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Outcome measures include assessment of strength, motor control, functional status, and patient satisfaction at intake, discharge, 6 and 12 months.

Studietyp

Interventionell

Inskrivning (Faktisk)

71

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Palo Alto, California, Förenta staterna, 94304-1290
        • VA Palo Alto Health Care System
      • West Los Angeles, California, Förenta staterna, 90073
        • VA Greater Los Angeles Healthcare System, West LA
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Michael E. DeBakey VA Medical Center (152)
      • Temple, Texas, Förenta staterna, 76504
        • Central Texas Veterans Health Care System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Over 21 years of age, weakness due to a recent stroke or other brain injury, and receiving rehabilitation. Subjects are inpatients at one of the participating VA hospitals.

Exclusion Criteria:

Unable to follow instructions; medically unstable.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Robot-Low
low-dose mechanically-assisted upper limb therapy
Övrig: Robot-Low
1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy
Experimentell: Robot-High
high-dose mechanically-assisted upper limb therapy
Övrig: Robot-High
2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
Aktiv komparator: Control
additional traditional therapy
Övrig: Control
1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fugl-Meyer Score Change Immediately Following Study Intervention.
Tidsram: After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.
After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
Fugl-Meyer Score Change at 6 Months
Tidsram: FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.
Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.
FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in FIM Score Immediately Following Study Intervention.
Tidsram: After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.
After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
Change in FIM Score at 6-months
Tidsram: Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.

Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63

.
Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

US Department of Veterans Affairs

Utredare

  • Huvudutredare: Charles Burgar, MD, Central Texas Veterans Health Care System

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2002

Primärt slutförande (Faktisk)

1 juli 2008

Avslutad studie (Faktisk)

1 juli 2008

Studieregistreringsdatum

Först inskickad

14 september 2005

Först inskickad som uppfyllde QC-kriterierna

14 september 2005

Första postat (Uppskatta)

22 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 februari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 januari 2014

Senast verifierad

1 januari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B2695-I

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