Physiotherapy and Action-Observation Therapy: An Integrated Approach for Upper Limb Impairment in Subacute Stroke
NCT ID: NCT04560764
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-01-01
2023-12-30
Brief Summary
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This study evaluates the addition of Action Observation Therapy (AOT) to Virtual Reality (VR) in the rehabilitation of upper limb impairment in subacute stroke patients. Half of participants will see a video demonstrating the exercise to be performed before its actual execution, while the other half will see a video of a natural landscape followed by the same exercises the other group performs. All the patients will receive additional usual treatment.
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Detailed Description
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* HTC Vive (HTC, headset e Steam station): three-dimensional viewer used for the implementation of the immersive virtual environment, allows both the visualization of the videos and of the exercises to be performed;
* Leap Motion Controller (infrared camera): contactless device for tracking the movement of the patient's fingers and hand;
* Zed Mini (RGB binocular camera and depth camera): Stereo Labs' Zed Mini stereoscopic camera is mounted on the HTC Vive viewer to allow virtual elements to be overlapped within the environment;
* Cometa Wavetrack (transmitter/receiver and Inertial Measurement Units): system for upper limb movement tracking through the use of four wireless inertial sensors applied to the chest, to the arm and to the forearm of the participant through elastic bands and to the hand of the participant through skin-compatible double-sided adhesive patches.
All the devices have been tested to ensure safety of the participants and are provided with the appropriate documentation of declaration of conformity according to the European reference regulations. A careful risk analysis was carried out to ensure the safety of the participants.
All the devices will be working simultaneously during each session of treatment. For the experimental group, the instrumentation will be used to see the video of the exercises that the participants will be later asked to perform and to actually perform them; in the control group, it will be used to see a video of a natural landscape with a 180° perspective and to perform the same exercises than the experimental group.
The devices will be used both for the execution of the exercises both to collect information listed in the outcomes section as secondary outcomes: in particular, these information will be provided by the Leap Motion and by the Cometa Wavetrack devices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Virtual Reality + Action Observation Therapy
Participants will see a video demonstrating the exercise they will be later asked to perform. The same procedure is performed for each of the four different exercises.
Virtual Reality
Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises.
There are four exercises:
1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time;
2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time;
3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time;
4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch.
Each exercise provides six levels of increasing difficulty.
Action Observation Therapy
Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes.
Standard treatment
Participants in both groups will receive the standard treatment, one hour a day for three days a week.
Virtual Reality + Landscape video
Participants will see a video demonstrating a natural landscape and later they will perform an exercise. The same procedure is performed for each of the four different exercises.
Virtual Reality
Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises.
There are four exercises:
1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time;
2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time;
3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time;
4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch.
Each exercise provides six levels of increasing difficulty.
Landscape video
Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the sham comparator group will see a video of a natural landscape for two minutes.
Standard treatment
Participants in both groups will receive the standard treatment, one hour a day for three days a week.
Interventions
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Virtual Reality
Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises.
There are four exercises:
1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time;
2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time;
3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time;
4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch.
Each exercise provides six levels of increasing difficulty.
Action Observation Therapy
Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes.
Landscape video
Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the sham comparator group will see a video of a natural landscape for two minutes.
Standard treatment
Participants in both groups will receive the standard treatment, one hour a day for three days a week.
Eligibility Criteria
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Inclusion Criteria
* Baseline scoring of the Upper Extremity portion of the Fugl Meyer between 20 and 60.
Exclusion Criteria
* Visual field impairments;
* Neuropsychological deficits that prevents the understanding of the instructions or the execution of the treatment (e.g. aphasia, apraxia, neglect);
* Baseline scoring of the Mini Mental State Examination (MMSE) lower that 24 (MMSE \< 24);
* Orthopaedic or musculoskeletal limitations that do not allow the execution of the treatment;
* Clinical instability;
* Inability to understand the instructions needed to perform the test and the planned evaluations;
* People with electronic medical devices such as pacemakers;
* Medical history of epilepsy.
18 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Riccardo Buraschi
Principal investigator
Principal Investigators
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Riccardo Buraschi, DPT
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi
Locations
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Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza
Rovato, Brescia, Italy
Countries
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References
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Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
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.
Borges LR, Fernandes AB, Melo LP, Guerra RO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD011887. doi: 10.1002/14651858.CD011887.pub2.
Shih TY, Wu CY, Lin KC, Cheng CH, Hsieh YW, Chen CL, Lai CJ, Chen CC. Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.
Kim C-H, Bang D-H. Action observation training enhances upper extremity function in subacute stroke survivor with moderate impairment: a double-blind, randomized controlled pilot trial. J Korean Soc Phys Med. 2016;11(1):133-140. doi:10.13066/kspm.2016.11.1.133
Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.
Kuk EJ, Kim JM, Oh DW, Hwang HJ. Effects of action observation therapy on hand dexterity and EEG-based cortical activation patterns in patients with post-stroke hemiparesis. Top Stroke Rehabil. 2016 Oct;23(5):318-25. doi: 10.1080/10749357.2016.1157972. Epub 2016 Mar 31.
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.
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.
Saposnik G, Cohen LG, Mamdani M, Pooyania S, Ploughman M, Cheung D, Shaw J, Hall J, Nord P, Dukelow S, Nilanont Y, De Los Rios F, Olmos L, Levin M, Teasell R, Cohen A, Thorpe K, Laupacis A, Bayley M; Stroke Outcomes Research Canada. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial. Lancet Neurol. 2016 Sep;15(10):1019-27. doi: 10.1016/S1474-4422(16)30121-1. Epub 2016 Jun 27.
Dorman PJ, Waddell F, Slattery J, Dennis M, Sandercock P. Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke. 1997 Oct;28(10):1876-82. doi: 10.1161/01.str.28.10.1876.
Franceschini M, La Porta F, Agosti M, Massucci M; ICR2 group. Is health-related-quality of life of stroke patients influenced by neurological impairments at one year after stroke? Eur J Phys Rehabil Med. 2010 Sep;46(3):389-99. Epub 2010 Apr 13.
Lee KW, Kim SB, Lee JH, Lee SJ, Kim JW. Effect of Robot-Assisted Game Training on Upper Extremity Function in Stroke Patients. Ann Rehabil Med. 2017 Aug;41(4):539-546. doi: 10.5535/arm.2017.41.4.539. Epub 2017 Aug 31.
Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
Other Identifiers
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FDG_AOTVR
Identifier Type: -
Identifier Source: org_study_id
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