Clinical trial NCT06196229: Effects of Action Observation Therapy Based on Virtual Reality for Upper Extremity Rehabilitation in Stroke
Official title: Effects of Action Observation Therapy Based on Virtual Reality for Upper Extremity Rehabilitation in Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Action Observation Therapy
Motor learning
Rehabilitation
Stroke
Upper Extremity Motor Function
Virtual reality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to conduct a randomized controlled trial (RCT) assessing the effectiveness of combining Action Observation (AO) with Virtual Reality (VR) in improving upper limb function for stroke patients compared to AO therapy alone.

Individuals who meet the inclusion criteria will be assigned by lottery into one of two groups: Group A will receive only AO therapy, watching daily actions and then executing them, while Group B will receive both AO and VR therapy, using VR glasses to complete tasks. The Box and Block Test for manual dexterity, the Timed Test, the Modified Ashworth Scale for spasticity, the Rankin Scale for symptom severity, and the Fugl-Meyer Assessment for motor, balance, sensation, and joint function will all be used in the evaluation, both before and after the intervention. Every participant will go through 18 sessions totaling 60

Detailed description: The rehabilitation of paretic stroke patients uses a wide range of intervention programs to improve the function of impaired upper limb. A new rehabilitative approach, called action observation therapy (AOT) is based on the discovery of mirror neurons and has been used to improve the motor functions of adult stroke patients and children with cerebral palsy. Recently, virtual reality (VR) has provided the potential to increase the frequency and effectiveness of rehabilitation treatment by offering challenging and motivating tasks. The purpose of the present project is to design a randomized controlled trial (RCT) to evaluate whether action observation (AO) added to standard VR (AO+VR) is effective in improving upper limb function in patients with stroke, compared with an action observation therapy alone.

Non-probability sampling technique will be used. After signing the consent form, the participant who met the inclusion criteria will be allocated to this study. Lottery Method will be used for the randomization of subjects in two groups. For the blindness of the accessor, the concealment process (Closed Envelope Method) will be maintained. Group A (will be given Action Observation Therapy only), During each training session, participants will be asked to observe a specific object-directed daily action presented on a computer screen, and afterward they will perform what they have observed. Group B (will be given Action Observation Therapy combined with Virtual Reality), the participant will sit in the center of the set zone and will be assisted to wear the VR glasses. After the participant will confirm that the sight and sound is clear and comfortable, the tasks will be done using virtual reality videos. Data will be collected at baseline and after 6 weeks using Box and Block Test (Measures unilateral gross manual dexterity), Timed Test (To check the time duration for each task), Modified Ashworth Scale (To assess spasticity), Rankin Scale (To categorize severity of symptoms) and Fugl-Meyer Assessment for Upper Extremity (FMA-UE): to assess motor functioning, balance, sensation and joint functioning. All participants will receive 18 sessions of intervention for 60 min/day, 3 days/week for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* • Both Male \& Female

  * 40-60 years of age
  * Primarily motor symptoms with unilateral upper limb paresis (controlled via standard neurological examination)
  * Residual movement ability of the paretic upper limb, controlled by Medical Research Council (MRC) index (\> 2 and \< 4), active use of the hemiplegic limb, from minimal (mainly for assistance tasks to the preserved limb) to discrete (characterized by coarse manipulation and an inability to perform precision grip)
  * mini-mental state examination (MME) score ≥27
  * Sufficient cooperation and cognitive understanding to participate to the activities, controlled by the investigator recruiting the patient

Exclusion Criteria:

* • Presence of severe cognitive impairment (score \< 20 at Mini Mental State Examination \[MMSE\])

  * Presence of severe forms of unilateral spatial neglect, controlled using the Bells Test (cut-off = / \> 50%)
  * Presence of severe ideomotor Apraxia
  * Presence of severe anosognosia, assessed by clinical examination
  * Presence of severe language comprehension deficits, assessed by clinical examination.
  * Presence of severe untreated psychiatric disorders
  * Sensory impairments hindering participation and/or not compensated visual deficits of central origin
  * Drug-resistant epilepsy

Primary outcomes:
measure: Box and Block Test (BBT)
timeFrame: 6 Weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: 6 weeks
measure: Rankin Scale (RS)
timeFrame: 6 weeks
measure: Fugl-Meyer Assessment Upper Extremity (FMA-UE)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tasneem Shahzadi, Phd*
role: PRINCIPAL_INVESTIGATOR
References:
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