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De klinische studie NCT06244719 voor Beroerte is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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University of Colorado, DenverVibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation
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De klinische studie NCT06244719 onderzoekt behandeling bij Beroerte. Deze Fase 1 interventioneel-studie heeft de status recruterend. Het doel is om 24 deelnemers te includeren vanaf 2 februari 2024. De studie wordt geleid door University of Colorado, Denver en de voltooiing is gepland op 2 februari 2025. Laatste update op ClinicalTrials.gov: 11 april 2024.
Beknopte samenvatting
The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:
Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?
Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.
Officiële titel
Vibrotactile Stimulation for Neurological Disorders
Aandoeningen
BeroerteAndere studie-ID's
- 23-0783
NCT-ID
Startdatum (Werkelijk)
2024-02-02
Laatste update geplaatst
2024-04-11
Verwachte einddatum
2025-02-02
Inschrijving (Geschat)
24
Studietype
Interventioneel
FASE
Fase 1
Status
Recruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelVibrotactile Stimulation Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day. | Vibrotactiele stimulatie Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips. |
Geen interventieControl Participants undergo conventional therapy only. | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM) | An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66. | Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Number of participants with at least one adverse event | Adverse event will only include those that are determined to be related to the vibrotactile stimulation | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
Number of participants who completed the therapy | Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
Number of participants who tolerated the vibrotactile stimulation therapy | Therapy tolerability will be assessed by responses to questionnaires | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
Change in the modified Ashworth scale | The modified Ashworth scale is used to assess spasticity and tests the resistance to passive movement about a joint with varying degree of velocity. The modified Ashworth scale assigns a grade of spasticity from a 0-4 ordinal scale | Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
50 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Inpatients at rehabilitation units
- Unilateral left or right sided ischemic stroke within the previous 2 weeks
- Have Upper-Extremity Fugl-Meyer scores between 6 and 58
- Have at least 20 degrees of active shoulder elevation and elbow flexion
- Expected to stay 1-3 weeks in the rehabilitation unit
- Under anti-spasticity therapy
- Patients that are dependent on pacemakers
- Patients that have defibrillators
- Have lymphedema or AV fistula for dialysis on an arm
University of Colorado, Denver489 actieve klinische studies om te verkennenCentraal Contactpersoon
Contact: Mazen Al Borno, PhD, 303-315-1408, [email protected]
2 Studielocaties in 1 landen
Colorado
UCHealth Rehabilitation Unit, Aurora, Colorado, 80045, United States
Mazen Al Borno, Contact, 650-441-7556, [email protected]
Recruterend
Broomfield Hospital, Broomfield, Colorado, 80021, United States
Mazen Al Borno, Contact, 650-441-7556, [email protected]
Recruterend