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StrokeNCT06196229

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

A study testing Action Observation Therapy and Action Observation Therapy combined with Virtual Reality in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Stroke
What is being tested?
Action Observation Therapy and Action Observation Therapy combined with Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
25 Nov 2023to 1 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

Imran Amjad, Phd contact

033224390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • Riphah International University

    Lahore, Punjab Province, 54000

    imran Amjad, Phd, 033224390125, imran.amjad@riphah.edu.pk

    Tasneem Shahzadi, Phd*, 03104108327, Tasneem.shehzadi@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

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

Read the 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.

Conditions
Stroke
Being tested
Action Observation Therapy, Action Observation Therapy combined with Virtual Reality
Keywords
Action Observation Therapy, Motor learning, Rehabilitation, Stroke, Upper Extremity Motor Function, Virtual reality
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Action Observation TherapyOther

    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

  • Action Observation Therapy combined with Virtual RealityOther

    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
Study groups in NCT06196229
Study groupRoleWhat they receive
Action Observation TherapyActive comparatorDuring 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
Receives: Other: Action Observation Therapy
Action Observation Therapy combined with Virtual RealityExperimentalIn 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
Receives: Other: Action Observation Therapy combined with Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Box and Block Test (BBT)

    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.

    Measured: 6 Weeks

  2. Modified Ashworth Scale (MAS)

    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.

    Measured: 6 weeks

  3. Rankin Scale (RS)

    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.

    Measured: 6 weeks

  4. Fugl-Meyer Assessment Upper Extremity (FMA-UE)

    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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start25 Nov 2023
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196229
Sponsor's protocol ID
REC/RCR & AHS/23/0254
Status last verified
Jun 2024
First submitted
25 Dec 2023
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang B, Kan L, Dong A, Zhang J, Bai Z, Xie Y, Liu Q, Peng Y. The effects of action observation training on improving upper limb motor functions in people with stroke: A systematic review and meta-analysis. PLoS One. 2019 Aug 30;14(8):e0221166. doi: 10.1371/journal.pone.0221166. eCollection 2019.

    PubMed 31469840

  • Rizzolatti G, Cattaneo L, Fabbri-Destro M, Rozzi S. Cortical mechanisms underlying the organization of goal-directed actions and mirror neuron-based action understanding. Physiol Rev. 2014 Apr;94(2):655-706. doi: 10.1152/physrev.00009.2013.

    PubMed 24692357

  • Alamer A, Melese H, Adugna B. Effectiveness of Action Observation Training on Upper Limb Motor Function in Children with Hemiplegic Cerebral Palsy: A Systematic Review of Randomized Controlled Trials. Pediatric Health Med Ther. 2020 Sep 15;11:335-346. doi: 10.2147/PHMT.S266720. eCollection 2020.

    PubMed 32982541

  • Buccino G, Molinaro A, Ambrosi C, Arisi D, Mascaro L, Pinardi C, Rossi A, Gasparotti R, Fazzi E, Galli J. Action Observation Treatment Improves Upper Limb Motor Functions in Children with Cerebral Palsy: A Combined Clinical and Brain Imaging Study. Neural Plast. 2018 Jul 4;2018:4843985. doi: 10.1155/2018/4843985. eCollection 2018.

    PubMed 30123250

  • Caligiore D, Mustile M, Spalletta G, Baldassarre G. Action observation and motor imagery for rehabilitation in Parkinson's disease: A systematic review and an integrative hypothesis. Neurosci Biobehav Rev. 2017 Jan;72:210-222. doi: 10.1016/j.neubiorev.2016.11.005. Epub 2016 Nov 16.

    PubMed 27865800

  • Rizzolatti G, Fogassi L. The mirror mechanism: recent findings and perspectives. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130420. doi: 10.1098/rstb.2013.0420. Print 2014.

    PubMed 24778385

  • Lee SH, Kim SS, Lee BH. Action observation training and brain-computer interface controlled functional electrical stimulation enhance upper extremity performance and cortical activation in patients with stroke: a randomized controlled trial. Physiother Theory Pract. 2022 Sep;38(9):1126-1134. doi: 10.1080/09593985.2020.1831114. Epub 2020 Oct 7.

    PubMed 33026895

  • Fu J, Zeng M, Shen F, Cui Y, Zhu M, Gu X, Sun Y. Effects of action observation therapy on upper extremity function, daily activities and motion evoked potential in cerebral infarction patients. Medicine (Baltimore). 2017 Oct;96(42):e8080. doi: 10.1097/MD.0000000000008080.

    PubMed 29049194

  • Mancuso M, Damora A, Abbruzzese L, Navarrete E, Basagni B, Galardi G, Caputo M, Bartalini B, Bartolo M, Zucchella C, Carboncini MC, Dei S, Zoccolotti P, Antonucci G, De Tanti A. A New Standardization of the Bells Test: An Italian Multi-Center Normative Study. Front Psychol. 2019 Jan 22;9:2745. doi: 10.3389/fpsyg.2018.02745. eCollection 2018.

    PubMed 30723446

  • Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

    PubMed 29156493

  • Alaca N, Ocal NM. Proprioceptive based training or modified constraint-induced movement therapy on upper extremity motor functions in chronic stroke patients: A randomized controlled study. NeuroRehabilitation. 2022;51(2):271-282. doi: 10.3233/NRE-220009.

    PubMed 35599504

  • Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.

    PubMed 8024419

  • Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; CONSORT-SPI Group. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018 Jul 31;19(1):407. doi: 10.1186/s13063-018-2733-1.

    PubMed 30060754

  • Errante A, Saviola D, Cantoni M, Iannuzzelli K, Ziccarelli S, Togni F, Simonini M, Malchiodi C, Bertoni D, Inzaghi MG, Bozzetti F, Menozzi R, Quarenghi A, Quarenghi P, Bosone D, Fogassi L, Salvi GP, De Tanti A. Effectiveness of action observation therapy based on virtual reality technology in the motor rehabilitation of paretic stroke patients: a randomized clinical trial. BMC Neurol. 2022 Mar 22;22(1):109. doi: 10.1186/s12883-022-02640-2.

    PubMed 35317736

Questions about this trial

What is this clinical trial studying?

A study testing Action Observation Therapy and Action Observation Therapy combined with Virtual Reality in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad, Phd (033224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Box and Block Test (BBT) (time frame: 6 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06196229, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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