Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg
13 november 2012 uppdaterad av: Tibion Bionics, Inc.
A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg
The objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force distribution) movement state in these patients.
Studieöversikt
Detaljerad beskrivning
Comprehensive motion (kinetics and kinematics) data specific to sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg. The Vicon Motion Analysis System will be utilized to track movement using markers on the subject and the Bionic Leg per the UCSF Human Performance Center's routine. Once outfitted with the marker system, patients will be instructed to perform multiple sit-to-stand and stand-to-sit transfers while data is gathered.
The sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12" from the floor. The chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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San Francisco, California, Förenta staterna, 94158
- UCSF Human Performance Center
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Sunnyvale, California, Förenta staterna, 94085
- Tibion Corporation
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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
30 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Single ischemic stroke with residual unilateral lower-extremity weakness
- Chronic post-stroke (>12 months since event)
- Eligible to participate to lower extremity physical therapy
- Age 30 years or greater
- Able to ambulate at least 10 meters without therapist assistance
- Able to ambulate without a leg brace
- Able to transfer from sitting to standing without physical assistance from a therapist
- Able to transfer from standing to sitting without physical assistance from a therapist
- Subject must understand the nature of the study and provide written informed consent prior to enrollment.
- Subject must be willing and able to attend all study sessions
Exclusion Criteria:
- Medically unstable
- Age younger than 30 years
- Subacute post-stroke (< 12 months since event)
- Status-post multiple strokes
- Status-post traumatic brain injury
- Not eligible to participate in lower extremity physical therapy
- Concomitant degenerative neurological conditions
- Not able to ambulate at least 10 meters without therapist assistance
- Unable to ambulate without a leg brace
- Unable to transfer from sitting to standing without physical assistance from a therapist
- Unable to transfer from standing to sitting without physical assistance from a therapist
- Unable to follow instructions, complete follow-up, or provide informed consent.
- Currently enrolled in another investigational device or drug trial
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Patient Population
Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.
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The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Force
Tidsram: Subject participation in the study is up to one (1) week.
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Force, in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation in the study is up to one (1) week.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Work
Tidsram: Subject participation in study is up to one (1) week.
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Work, in Joules (J), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation in study is up to one (1) week.
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Torque
Tidsram: Subject participation is up to one (1) week
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Torque, in Newton-meters (N-m), at the ankle and knee, by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation is up to one (1) week
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Moment
Tidsram: Subject participation is up to one (1) week
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Moment at the ankle and knee in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.
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Subject participation is up to one (1) week
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Joshua G Vose, MD, Tibion Corporation
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
- Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14.
- Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581.
- Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.
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 maj 2012
Primärt slutförande (Faktisk)
1 november 2012
Avslutad studie (Faktisk)
1 november 2012
Studieregistreringsdatum
Först inskickad
18 juni 2012
Först inskickad som uppfyllde QC-kriterierna
21 juni 2012
Första postat (Uppskatta)
22 juni 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
14 november 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 november 2012
Senast verifierad
1 november 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CP 007
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .