Stroke Clinical Trial
— PHOENICSOfficial title:
Virtual Reality and Action-Observation Therapy: An Integrated Approach Supported by Novel Technologies for Upper Limb Impairment in Subacute Stroke
Motor impairment is one of the most common result of a stroke, which causes disability and difficulties in activities of daily living. This motor impairment can concern the upper limb or the lower limb, or both. Several studies investigates the efficacy of different treatment approaches on upper limb and hand function. None of them combined exercise in a virtual context with Action Observation Therapy, consisting in watching an action before doing it. 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.
Status | Not yet recruiting |
Enrollment | 22 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participant who suffered from an ictus 3 to 6 months before (subacute phase); - Baseline scoring of the Upper Extremity portion of the Fugl Meyer between 20 and 60. Exclusion Criteria: - Other neurological pathologies (including previous strokes); - 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. |
Country | Name | City | State |
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Italy | Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza | Rovato | Brescia |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus |
Italy,
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:CD011887. doi: 10.1002/14651858.CD011887.pub2. Review. — View Citation
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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. — View Citation
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. — View Citation
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
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. — View Citation
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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. — View Citation
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. — View Citation
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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. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Upper limb function | Upper extremity portion of the Fugl Meyer (UE-FM). This scale measures the function of the upper limb in a range of 0 to 66 points. Higher values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Primary | Change of hand dexterity | Box and Block test. This test examines hand dexterity measuring the number of wooden blocks the participant is able to move from one box to another with the paretic hand in 60 seconds. Higher values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of autonomy | Barthel Index. This scale measures the ability of the subject to perform activities of daily living. Range 0-100. Higher values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of quality of Life | EuroQol-5D questionnaire. This questionnaire measures the quality of life. Range 5-15. Lower values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of level completed | Most difficult level the participant is able to complete, from 1 to 6. Higher values represent a better performance. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of number of correct tasks | Number of tasks the participants performs correctly. Higher values represent a better performance. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of reaction time | Seconds from the appearance of the target to the start of the movement. Lower values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of interaction time | Seconds from the appearance of the target to its reaching. Lower values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of mean time of exercise execution | Seconds required for single exercise execution. Lower values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Level of Satisfaction | Likert 1-5. This scale measures the level of satisfaction of the subject regarding the treatment. Higher values represent a better outcome. | At the end of the treatment (4 weeks). | |
Secondary | Change of Hand Max Reaching Velocity | Maximal velocity (meters/seconds) of the hand movement during reaching of the target. Higher values represent a better outcome. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of % Cycle Hand Max Velocity | Dividing the interaction time between the hand and the object into 100 parts, it represents the moment in which the hand reaches the maximal velocity. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of Mean SPARC | Spectral parameter related to the smoothness of the movement. Negative values lower than -1 stand for lower smoothness. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of Mean Reach Path Ratio | Parameter calculated as total distance traveled by the wrist of the subject divided by the length of a straight-line path from the reach's starting point (hand resting on the table) to ending point (target). Values equal or close to +1 represent a straight trajectory, while higher values stand for a more curved one. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of Tip Max Distance | Maximal distance between the thumb and index fingertips. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). | |
Secondary | Change of Tip Max Velocity | Maximal velocity of opening and closing between the thumb and index fingertips. | Baseline (T0) and at the end of the treatment (T1, after 4 weeks). |
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