- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02577276
Evaluation of a Tele-Rehabilitation Service Program
Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing clinical practice and recruited either in person or by using a phone script.
Eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. The first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. During this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. The second clinical assessment will include acquiring post-intervention clinical and outcome measures. Intervention duration will be 3 months. During the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. During these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. After the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. Such self-training opportunities are in addition to the twice weekly online sessions with the therapist.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Minnesota
-
Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion
- >12 months after stroke
- Age 21-80 years
- A minimum of 45 degrees of flexion in the affected shoulder
- Active extension of the affected elbow to 150 degrees
- Independent sitting balance
- Able to understand simple instructions
- Lives within a 100 mile radius and able to attend two clinical assessments at Mayo Clinic
- Able to install the tele-rehabilitation software with minimal remote technical support
- Available caregiver as needed who has basic technical understanding of computer operation
- i3 processor based PC; 26" monitor; Windows 7 or 8 operating system; Internet connection of at least 10Mbps.
Exclusion
- Medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise
- Any contraindication related to the integrity of the musculoskeletal system
- Active malignancy
- Uncontrolled epilepsy
- Global aphasia
- Severe apraxia
- Severe ataxia
- Unilateral spatial neglect
- Chronic pain
- Pregnancy
- Adults lacking capacity
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Tele-motion rehabilitation system
Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
|
Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback.
Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Satisfaction Questionnaire
Tijdsspanne: 3 months
|
Clinician and participant satisfaction questionnaire
|
3 months
|
System Usability Scale
Tijdsspanne: 3 months
|
Clinician and participant usability questionnaire
|
3 months
|
Qualitative measure of technology/communications problems
Tijdsspanne: 3 months
|
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
|
3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Upper limb (shoulder, elbow) range of motion
Tijdsspanne: Baseline and at 3 months
|
Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer
|
Baseline and at 3 months
|
Fugl- Meyer Scale
Tijdsspanne: Baseline and at 3 months
|
Fugl- Meyer Assessment for the participant's upper limb
|
Baseline and at 3 months
|
Motor Activity Log (MAL)
Tijdsspanne: Baseline and at 3 months
|
Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL), 28 functional tasks (MAL 28) or 14 tasks (MAL 14).
Target tasks include object manipulation (e.g.
pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g.
transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).
Items scored on a 6-point ordinal scale.
|
Baseline and at 3 months
|
Measures from the ReAbility Online system of participant and clinician activity
Tijdsspanne: Weekly through 3-month study period
|
Time of practice by participant as measured by the ReAbility Online system
|
Weekly through 3-month study period
|
Task performance scores
Tijdsspanne: Weekly through 3-month study period
|
Participant task performance scores as measured by the ReAbility Online system
|
Weekly through 3-month study period
|
Upper limb range of motion
Tijdsspanne: Weekly through 3-month study period
|
Upper limb range of motion of participant as measured by the ReAbility Online system
|
Weekly through 3-month study period
|
Number of compensatory movements
Tijdsspanne: Weekly through 3-month study period
|
Number of compensatory movements as measured by the ReAbility Online system
|
Weekly through 3-month study period
|
Time online
Tijdsspanne: Weekly through 3-month study period
|
Time online of participant and clinician as measured by the ReAbility Online system
|
Weekly through 3-month study period
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Allen Brown, MD, Mayo Clinic
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
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 (Werkelijk)
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
- 15-006308
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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 .
Klinische onderzoeken op Tele-motion rehabilitation system
-
Donders Centre for NeuroscienceWervingHartinfarctFrankrijk, Roemenië, Spanje
-
IRCCS Eugenio MedeaWervingSpierdystrofieën | Becker spierdystrofie | Ledematen Gordel Spierdystrofie | Facio-Scapulo-Humerale DystrofieItalië