- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01626417
Evaluation of Transfer Kinematics and Kinetics in Patients Chronic Post-stroke Using the Tibion Bionic Leg
A Prospective, Experimental Study to Evaluate Transfer Kinematics and Kinetics of Chronic Post-stroke Patients With Tibion Bionic Leg
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94158
- UCSF Human Performance Center
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Sunnyvale, California, États-Unis, 94085
- Tibion Corporation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Force
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Work
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Joshua G Vose, MD, Tibion Corporation
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CP 007
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