Physiotherapy and Action-Observation Therapy: An Integrated Approach for Upper Limb Impairment in Subacute Stroke

NCT04560764 | Withdrawn

• 1 other identifier: FDG_AOTVR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Upper limb impairment; Virtual Reality; Action Observation Therapy

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (14)

• Change of autonomy

  Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

• Change of quality of Life

  Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

• Change of level completed

  Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

• Change of number of correct tasks

  Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

• Change of reaction time

  Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

Study Arms (2)

Virtual Reality + Action Observation Therapy

EXPERIMENTAL

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.

Device: Virtual Reality; Device: Action Observation Therapy; Other: Standard treatment

Virtual Reality + Landscape video

SHAM COMPARATOR

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.

Device: Virtual Reality; Device: Landscape video; Other: Standard treatment

Interventions

Virtual Reality DEVICE

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.

Virtual Reality + Action Observation Therapy; Virtual Reality + Landscape video

Action Observation Therapy DEVICE

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.

Virtual Reality + Action Observation Therapy

Landscape video DEVICE

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.

Virtual Reality + Landscape video

Standard treatment OTHER

Participants in both groups will receive the standard treatment, one hour a day for three days a week.

Virtual Reality + Action Observation Therapy; Virtual Reality + Landscape video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Rovato, Brescia, 25038, Italy

Location

Related Publications (15)

• 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.

  PMID: 25387001 BACKGROUND

• 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.

  PMID: 29156493 BACKGROUND

• 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.

  PMID: 30380586 BACKGROUND

• 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.

  PMID: 28978349 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22235059 BACKGROUND

• 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.

  PMID: 20848369 BACKGROUND

• 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.

  PMID: 27077994 BACKGROUND

• 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.

  PMID: 8024419 BACKGROUND

• 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.

  PMID: 29049194 BACKGROUND

• 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.

  PMID: 27365261 BACKGROUND

• 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.

  PMID: 9341688 BACKGROUND

• 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.

  PMID: 20927005 BACKGROUND

• 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.

  PMID: 28971037 BACKGROUND

• 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.

  PMID: 19608100 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Riccardo Buraschi, DPT

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: September 23, 2020
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 30, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

IT (1)