- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02803255
AAN Robotic Therapy in SCI
Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- TIRR Memorial Hermann
-
Houston, Texas, Verenigde Staten, 77005
- Rice University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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:
|
|
Actieve vergelijker: 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.
|
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in ARAT score
Tijdsspanne: 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
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Modified Ashworth Scale
Tijdsspanne: 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
|
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
|
|
|
Change in Grip Pinch Strength Assessment
Tijdsspanne: 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
|
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
|
|
|
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Tijdsspanne: 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
|
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
|
|
|
Change in Smoothness metrics
Tijdsspanne: 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
|
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
|
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
|
|
Change in smoothness metrics
Tijdsspanne: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
|
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
|
Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Marcia K. O'Malley, PhD, William Marsh Rice University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14-027F
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .