- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02803255
AAN Robotic Therapy in SCI
Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- TIRR Memorial Hermann
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Houston, Texas, Vereinigte Staaten, 77005
- Rice University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.
Inclusion Criteria:
- Providing written informed consent prior to any study related procedures;
- Age between 18-75 years;
- Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
- Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
- No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
- Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
- No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
Exclusion Criteria: Subjects will be excluded if they have:
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- Subject who cannot provide self-transportation to the study location.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Assist-As-Needed Control
Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol. Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion. |
Andere Namen:
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Aktiver Komparator: Subject-Triggered Control
Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system.
In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e.
elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension).
The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall.
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Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Change in ARAT score
Zeitfenster: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Modified Ashworth Scale
Zeitfenster: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Grip Pinch Strength Assessment
Zeitfenster: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Zeitfenster: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Smoothness metrics
Zeitfenster: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Measured via analysis of point-to-point reaching movements performed with the robot.
Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in smoothness metrics
Zeitfenster: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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Measured via analysis of point-to-point reaching movements performed with the robot.
Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
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Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Marcia K. O'Malley, PhD, William Marsh Rice University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 14-027F
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