Effectiveness of Early Intervention With Virtual Reality-Based Interactive Rehabilitation on Upper Extremity Muscle Strength, Cognitive Status, Hospital Anxiety, and Exercise Self-Efficacy in Patients With Acute Ischemic Stroke
Effectiveness of Early Intervention With Virtual Reality-based Interactive Rehabilitation on Upper Extremity Muscle Strength, Cognitive Status, Hospital Anxiety and Exercise Self-efficacy in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Project Title:
Effectiveness of Early Intervention Using a Virtual Reality Motion-Sensing Rehabilitation System on Improving Upper Limb Muscle Strength, Cognitive Status, and Self-Efficacy in Patients with Acute Ischemic Stroke
I. Project Description This study is divided into two groups: the experimental group and the control group. The experimental group will utilize a Virtual Reality (VR) motion-sensing rehabilitation APP, while the control group will receive traditional rehabilitation. The study aims to verify the outcomes and evaluate the effectiveness of early rehabilitation intervention using the VR motion-sensing APP in patients with acute ischemic stroke.
The planned sample size is 50 participants for the experimental group and 50 participants for the traditional rehabilitation group, totaling 100 participants. The recruitment sites are the Neurology Wards and the Stroke and Neurointensive Care Unit (SNICU) of Tri-Service General Hospital. The total duration of the study, including data analysis, is approximately one year.
II. Research Objectives Current research on rehabilitation training for patients after acute ischemic stroke predominantly focuses on the period from the post-acute phase up to six months. The primary objective of this study is to explore the effects of providing early virtual rehabilitation intervention-initiated 24 hours after a confirmed diagnosis of acute ischemic stroke-on the improvement of upper limb muscle strength, cognitive status, and the enhancement of patients' self-efficacy. By investigating these objectives, the study aims to provide a more effective method for early rehabilitation intervention during the acute phase of ischemic stroke and to boost patients' motivation for rehabilitation training.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: YUN QIAN LIN
- Telefonnummer: 88044 28973311
- E-post: yurilin0709@gmail.com
Studera Kontakt Backup
- Namn: Hui-Chen LIN
- E-post: cecilia@tmu.edu.tw
Studieorter
-
-
-
Taipei, Taiwan, 224
- Rekrytering
- Tri Service General Hospital
-
Kontakt:
- YUN QIAN LIN
- Telefonnummer: 88044 28973311
- E-post: yurilin0709@gmail.com
-
Kontakt:
- YUN QIAN LIN
- Telefonnummer: 88044 0933513418
- E-post: yurilin0709@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Diagnosis of acute ischemic stroke with ICD-10 codes: G45-G46.8, I63-I68.8.
- Within 10 days (inclusive) of stroke symptom onset.
- Age 18~85 years or older.
Exclusion Criteria:
- Comorbid neuromuscular or orthopedic conditions affecting upper limb function.)
- Recurrence of stroke or onset of seizures during the study period.
- Severe visual impairment or visuospatial neglect.
- Inability to cooperate or refusal to participate in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Early intervention in patients with acute ischemic stroke
virtual reality-based interactive rehabilitation
|
Virtual reality
|
|
Experimentell: traditional rehabilitation.
traditional bedside rehabilitation.
|
traditional bedside rehabilitation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
upper limbs function
Tidsram: 7days later
|
FMA-UE
|
7days later
|
|
cognitive status
Tidsram: 7days later
|
SLUME
|
7days later
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Self-Efficacy for Exercise (SEE) Scale Score
Tidsram: Baseline and 7 days after intervention
|
Self-efficacy will be assessed using the Self-Efficacy for Exercise (SEE) Scale.
The SEE is a 10-item questionnaire that evaluates participants' confidence in their ability to continue exercising under various circumstances.
Total scores range from 10 to 40, with higher scores indicating greater exercise self-efficacy.
|
Baseline and 7 days after intervention
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: YUN QIAN LIN, Tri-Service General Hospital (TSGH)
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- C202405171
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .