Effects of Action Observation Therapy Based on Virtual Reality for Upper Extremity Rehabilitation in Stroke

December 25, 2023 updated by: Riphah International University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Action Observation Therapy

During each training session, participants were asked to observe a specific object-directed daily action presented on a computer screen, and afterward they performed what they have observed, 5 repetitions of each task, time duration was noted.

16 motor tasks related to their daily living that were performed with their own hands which are following

  1. Folding a towel
  2. Cutting a toilet roll
  3. Using scissors
  4. Tightening shoelaces
  5. Opening and closing a square airtight container
  6. Opening a bottle top
  7. Turning a faucet
  8. Using a field of billfold
  9. Drinking water
  10. Setting a seal
  11. Changing batteries
  12. Opening and closing a zipper
  13. Turning over pages of a book
  14. Plugging the outlet
  15. Spraying water with a sprayer
  16. Sorting chopsticks and spoons and putting them in a box • The participants were advised to keep focusing on their affected arm/hand action observational tasks
Other: Action Observation Therapy

During each training session, participants were asked to observe a specific object-directed daily action presented on a computer screen, and afterward they performed what they have observed, 5 repetitions of each task, time duration was noted .

16 motor tasks related to their daily living that were performed with their own hands which are following

  1. Folding a towel
  2. Cutting a toilet roll
  3. Using scissors
  4. Tightening shoelaces
  5. Opening and closing a square airtight container
  6. Opening a bottle top
  7. Turning a faucet
  8. Using a field of billfold
  9. Drinking water
  10. Setting a seal
  11. Changing batteries
  12. Opening and closing a zipper
  13. Turning over pages of a book
  14. Plugging the outlet
  15. Spraying water with a sprayer
  16. Sorting chopsticks and spoons and putting them in a box • The participants were advised to keep focusing on their affected arm/hand action observational tasks
Experimental: Action Observation Therapy combined with Virtual Reality

In the VRT group, participants will execute VR-based activities conducted by the same therapist .

  • 16 tasks will be assigned in each session. VR SHINECON 3D Glasses will be used
  • The virtual environment was set in a 6 m2 physical space
  • At the beginning of each session, 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 mentioned in action observation therapy will be done using virtual reality videos
  • The Extrinsic feedback will be provided, including the time left, number of repetitions, and record number of repetitions
Other: Action Observation Therapy combined with Virtual Reality

In the VRT group, participants will execute VR-based activities conducted by the same therapist.

  • 16 tasks will be assigned in each session. VR SHINECON 3D Glasses will be used
  • The virtual environment was set in a 6 m2 physical space
  • At the beginning of each session, 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 mentioned in action observation therapy will be done using virtual reality videos
  • The Extrinsic feedback will be provided, including the time left, number of repetitions, and record number of repetitions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test (BBT)
Time Frame: 6 Weeks
The Box and Block Test (BBT) involves moving small blocks between two compartments in a predetermined amount of time in order to assess unilateral gross manual dexterity. The object of the game is to transfer as many 2.5 cm cubes from one side of a partitioned box to the other by the end of a time limit, say 60 seconds. The number of blocks that are successfully transferred determines the score, which is a measurable indicator of manual dexterity. Better unilateral gross manual dexterity performance is indicated by higher scores, which makes the BBT a standardised test for evaluating motor skills.
6 Weeks
Modified Ashworth Scale (MAS)
Time Frame: 6 weeks
The Modified Ashworth Scale (MAS) uses a scale of 0 to 4 to measure resistance during passive movement in order to evaluate muscle tone and spasticity. It measures the degree of rigidity or stiffness in the muscles, which helps in the assessment and planning of treatments for neurological conditions. Using the MAS scale, which ranges from 0 (no increase in tone) to 4 (severe rigidity), doctors can consistently evaluate patients' levels of spasticity.
6 weeks
Rankin Scale (RS)
Time Frame: 6 weeks
The functional disability following a stroke is measured by the Rankin Scale (mRS), which has a range of 0 (no symptoms) to 6 (death). It is an essential tool for assessing functional outcomes in neurological conditions because it evaluates an individual's capacity to carry out daily activities on their own. A standardised way to assess functional limitations following a stroke is the Rankin Scale, where 0 denotes no symptoms and 6 severe impairment or death.
6 weeks
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time Frame: 6 weeks
An essential instrument for assessing motor recovery in the upper limbs following a stroke is the Fugl Meyer Assessment for Upper Extremity (FMA-UE). Reflexes, coordination, sensation, and movements are evaluated, and scores range from 0 (severe impairment) to 66 (minimum or no impairment), the highest possible number. This thorough evaluation provides a thorough understanding of the extent of motor impairment and functional ability in particular upper limb tasks and movements. The FMA-UE is a standardised measure that helps monitor the progress of rehabilitation and assesses the efficacy of interventions targeted at improving upper extremity motor function after a stroke. It consists of a variety of tasks that assess motor functions.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Tasneem Shahzadi, Phd*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2023

Primary Completion (Estimated)

May 27, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

December 25, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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