Clinical trial NCT05193539: Effects of Comprehensive Augmented and Virtual Reality in Stroke Patients
Official title: Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Virtual Reality
Augmented Reality
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, single-blinded study. Individuals were randomly assigned to either the experimental group or control group using a computer-generated randomization technique. The randomization list was created on blocks of four and generated at the start of the study using a computerized program.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the efficacy of augmented and virtual reality-based rehabilitation programs on improving upper extremity function in subacute stroke patients.

Detailed description: This was a randomized, single-blinded study, conducted at a single acute rehabilitation unit in a university hospital. In this study, the effect of augmented and virtual reality-based rehabilitation for the recovery of subacute stroke patients compared with conventional occupational therapy was evaluated.

Eligibility criteria: Inclusion Criteria:

* First ever stroke
* Onset of stroke less than 3 months
* Sufficiently medically stable to participate in active rehabilitation
* Mild-to-moderate upper extremity motor impairments (Brunnstrom stage for the upper extremity 2-6).

Exclusion Criteria:

* Severe cognitive impairment (defined as score \< 10 on the Mini-Mental State Examination)
* Evidence of apraxia
* Clinical history of neglect
* Previous upper extremity hemiplegia.

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity score
timeFrame: Baseline
measure: Fugl-Meyer Assessment for Upper Extremity score
timeFrame: 2 weeks after intervention
Secondary outcomes:
measure: Box and Block Test
timeFrame: Baseline
measure: Box and Block Test
timeFrame: 2 weeks after intervention
measure: Modified Barthel Index
timeFrame: Baseline
measure: Modified Barthel Index
timeFrame: 2 weeks after intervention
measure: Motor Activity Log of Amount of Use and Quality of Movement
timeFrame: Baseline
measure: Motor Activity Log of Amount of Use and Quality of Movement
timeFrame: 2 weeks after intervention
measure: EuroQol Visual Analogue Scale
timeFrame: Baseline
measure: EuroQol Visual Analogue Scale
timeFrame: 2 weeks after intervention
measure: Berg Balance Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: 2 weeks after intervention
measure: Grip strength (kg)
timeFrame: Baseline
measure: Grip strength (kg)
timeFrame: 2 weeks after intervention
measure: Hand response reaction time
timeFrame: Baseline
measure: Hand response reaction time
timeFrame: 2 weeks after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: