- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02803255
AAN Robotic Therapy in SCI
Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- TIRR Memorial Hermann
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Houston, Texas, Forente stater, 77005
- Rice University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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. |
Andre navn:
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Aktiv 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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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in ARAT score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Modified Ashworth Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Marcia K. O'Malley, PhD, William Marsh Rice University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-027F
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