Evaluation of a Tele-Rehabilitation Service Program
Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Minnesota
-
Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic in Rochester
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Satisfaction Questionnaire
Časové okno: 3 months
|
Clinician and participant satisfaction questionnaire
|
3 months
|
|
System Usability Scale
Časové okno: 3 months
|
Clinician and participant usability questionnaire
|
3 months
|
|
Qualitative measure of technology/communications problems
Časové okno: 3 months
|
Self report text of problems and difficulty with experimental technology and communication from participants and clinicians
|
3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Upper limb (shoulder, elbow) range of motion
Časové okno: 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
Časové okno: Baseline and at 3 months
|
Fugl- Meyer Assessment for the participant's upper limb
|
Baseline and at 3 months
|
|
Motor Activity Log (MAL)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Allen Brown, MD, Mayo Clinic
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 15-006308
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Tele-motion rehabilitation system
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalNeznámý
-
Clalit Health ServicesUkončeno