Recovering arm function in chronic stroke patients using combined anodal HD-tDCS and virtual reality therapy (ReArm): a study protocol for a randomised controlled trial

Author(s):  
Camille O. Muller ◽  
Makii Muthalib ◽  
Denis Mottet ◽  
Stéphane Perrey ◽  
Gérard Dray ◽  
...  

Abstract Background After a stroke, 80% of the chronic patients have difficulties to use their paretic upper limb (UL) in activities of daily life (ADL) even after rehabilitation. Virtual reality therapy (VRT) and anodal transcranial direct current stimulation (tDCS) are two innovative methods that have shown independently to positively impact functional recovery of the paretic UL when combined with conventional therapy. The objective of the project will be to evaluate the impact of adding anodal high-definition (HD)-tDCS during an intensive 3-weeks UL VRT and conventional therapy program on paretic UL function in chronic stroke. Methods The ReArm project is a quadruple-blinded, randomized, sham-controlled, bi-centre, two-arm parallel, and interventional study design. Fifty-eight chronic (> 3 months) stroke patients will be recruited from the Montpellier and Nimes University Hospitals. Patients will follow a standard 3-weeks in-patient rehabilitation program, which includes 13 days of VRT (Armeo Spring, 1x30min session/day) and conventional therapy (3x30min sessions/day). Twenty-nine patients will receive real stimulation (4x1 anodal HD-tDCS montage, 2mA, 20min) to the ipsilesional primary motor cortex during the VRT session and the other 29 patients will receive active sham stimulation (2mA, 30s). All outcome measures will be assessed at baseline, at the end of rehabilitation and again 3 months later. The primary outcome measure will be the wolf motor function test. Secondary outcomes will include measures of UL function (Box and Block test), impairment (Fugl Meyer Upper Extremity), compensation (Proximal Arm Non-Use), ADL (Actimetry, Barthel Index), pain, fatigue, effort and performance, kinematics and motor cortical region activation during functional motor tasks. Discussion This will be the first trial to determine the impact of adding HD-tDCS during UL VRT and conventional therapy in chronic stroke patients. We hypothesise that improvements in UL function will be greater and longer-lasting with real stimulation than in those receiving sham. Trial registration: The ReArm project was approved by The French Research Ethics Committee, (Comité de Protection des Personnes-CPP SUD-EST II, N°ID-RCB: 2019-A00506-51, http://www.cppsudest2.fr/). The ReArm project was registered on ClinicalTrials.gov (NCT04291573, 2nd March 2020, https://clinicaltrials.gov/ct2/show/NCT04291573

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Camille O. Muller ◽  
Makii Muthalib ◽  
Denis Mottet ◽  
Stéphane Perrey ◽  
Gérard Dray ◽  
...  

Abstract Background After a stroke, 80% of the chronic patients have difficulties to use their paretic upper limb (UL) in activities of daily life (ADL) even after rehabilitation. Virtual reality therapy (VRT) and anodal transcranial direct current stimulation (tDCS) are two innovative methods that have shown independently to positively impact functional recovery of the paretic UL when combined with conventional therapy. The objective of the project will be to evaluate the impact of adding anodal high-definition (HD)-tDCS during an intensive 3-week UL VRT and conventional therapy program on paretic UL function in chronic stroke. Methods The ReArm project is a quadruple-blinded, randomized, sham-controlled, bi-centre, two-arm parallel, and interventional study design. Fifty-eight chronic (> 3 months) stroke patients will be recruited from the Montpellier and Nimes University Hospitals. Patients will follow a standard 3-week in-patient rehabilitation program, which includes 13 days of VRT (Armeo Spring, 1 × 30 min session/day) and conventional therapy (3 × 30 min sessions/day). Twenty-nine patients will receive real stimulation (4x1 anodal HD-tDCS montage, 2 mA, 20 min) to the ipsilesional primary motor cortex during the VRT session and the other 29 patients will receive active sham stimulation (2 mA, 30 s). All outcome measures will be assessed at baseline, at the end of rehabilitation and again 3 months later. The primary outcome measure will be the wolf motor function test. Secondary outcomes will include measures of UL function (Box and Block Test), impairment (Fugl Meyer Upper Extremity), compensation (Proximal Arm Non-Use), ADL (Actimetry, Barthel Index). Other/exploratory outcomes will include pain, fatigue, effort and performance, kinematics, and motor cortical region activation during functional motor tasks. Discussion This will be the first trial to determine the impact of adding HD-tDCS during UL VRT and conventional therapy in chronic stroke patients. We hypothesize that improvements in UL function will be greater and longer-lasting with real stimulation than in those receiving sham. Trial registration The ReArm project was approved by The French Research Ethics Committee, (Comité de Protection des Personnes-CPP SUD-EST II, N°ID-RCB: 2019-A00506-51, http://www.cppsudest2.fr/). The ReArm project was registered on ClinicalTrials.gov (NCT04291573, 2nd March 2020.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Adam MacLellan ◽  
Catherine Legault ◽  
Alay Parikh ◽  
Leonel Lugo ◽  
Stephanie Kemp ◽  
...  

Background: Stroke is the leading cause of disability worldwide, with many stroke survivors having persistent upper limb functional impairment. Aside from therapist-directed rehabilitation, few efficacious recovery tools are available for use by stroke survivors in their own home. Game-based virtual reality systems have already shown promising results in therapist-supervised settings and may be suitable for home-based use. Objective: We aimed to assess the feasibility of unsupervised home-based use of a virtual reality device for hand rehabilitation in stroke survivors. Methodology: Twenty subacute/chronic stroke patients with upper extremity impairment were enrolled in this prospective single-arm study. Participants were instructed to use the Neofect Smart Glove 5 days per week for 8 weeks, in single sessions of 50 minutes or two 25-minute sessions daily. We measured (1) compliance to prescribed rehabilitation dose, (2) patient impression of the intervention, and (3) efficacy measures including the upper extremity Fugl-Meyer (UE-FM), the Jebsen-Taylor hand function test (JTHFT) and the Stroke Impact Scale (SIS). Results: Seven subjects (35%) met target compliance of 40 days use, and 6 subjects (30%) used the device for 20-39 days; there were no age or gender differences in use. Subjective patient experience was favorable, with ninety percent of subjects reporting satisfaction with their overall experience, and 80% reporting perceived improvement in hand function (figure 1). There was a mean improvement of 26.6±48.8 seconds in the JTHFT ( p =0.03) and 16.1±15.3 points in the domain of the SIS that assesses hand function ( p <0.01). There was a trend towards improvement in the UE-FM (2.2±5.5 points, p =0.10). Conclusions: A novel virtual reality gaming device is suitable for unsupervised use in stroke patients and may improve hand/arm function in subacute/chronic stroke patients. A large-scale randomized controlled trial is needed to confirm these results.


2021 ◽  
Author(s):  
Hebing Liu ◽  
Zhaohua Cheng ◽  
Shuo Wang ◽  
Yong Jia ◽  
Chen Li

Abstract Background: Virtual Reality (VR) has been widely used in health-related fields. The aim of this study was to assess the effectiveness of virtual reality-based physical and psychological exercise on depression.Methods: A total of 752 patients with stroke from 11 randomized controlled trial (RCT) studies were included in this meta-analysis and the studies derived from 6 electronic databases searched from database inception to August 2021. For continuous results, the standardized mean differences (SMDs) and 95% confidence intervals (CIs) were calculated to synthesize the effects.Results: The meta-analysis showed that compared with control group, VR-based interventions significantly decreased the depression scale score (SMD = −0.71, 95% CI: −1.32, −0.10) in the subjects. The results showed that the the patient age and total intervention time had a significant impact on the outcome of depression. The smaller the age and longer the intervention duration, the greater the impact on the outcome of depression.Conclusions: The current meta-analysis indicated the virtual reality-based physical and psychological exercise has a significant effect on depression in stroke patients compared to controls. The study showed an outstanding reduction in depression for aged under 60 participants and intervention longer than 8 weeks. At the same time, clinical studies of different ages and different intervention time also need further in-depth study.


2015 ◽  
Vol 21 (3) ◽  
pp. 237-243 ◽  
Author(s):  
Wagner Henrique Souza Silva ◽  
Gleyson Luiz Bezerra Lopes ◽  
Kim Mansur Yano ◽  
Nathália Stephany Araújo Tavares ◽  
Isabelle Ananda Oliveira Rego ◽  
...  

AbstractThis study aimed to investigate the effect of a rehabilitation program using virtual reality (VR) in addition to conventional therapy for improvement of balance (BERG scale) and functional independence (FIM scale) in chronic stroke patients. Ten individuals, mean age of 51.4 (± 6.7 years), participated of eight 60-minute sessions comprising kinesiotherapy (15min), Nintendo Wii (30min) and Learning transfer (15min) exercises. After training, nonparametric statistical analysis showed significant improvement in total FIM (p= .01) and BERG scores (p= .00), and in some of their subitems: FIM - dressing lower body (p= .01), transfer to bathtub/shower (p= .02) and locomotion: stairs (p= .03); BERG - reaching forward with outstretched arm (p= .01), retrieving object from the floor (p= .04), turning 360º (p= .01), placing alternate foot on step (p≤ .01), standing with one foot in front (p= .01), and one leg stand (p= .03). These findings suggest a positive influence of virtual reality exercises adjunct to conventional therapy on rehabilitation of balance and functionality post stroke, and indicate the feasibility of the proposed VR-based rehabilitation program.


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