Initial analysis of comparing differences between active and sham-tDCS groups (univariate analysis), we found no significant differences. That led to more massaging of the data to come up with positive results.
http://www.hindawi.com/journals/bmri/2016/5068127/
Sofia Straudi,1 Felipe Fregni,2 Carlotta Martinuzzi,1 Claudia Pavarelli,1 Stefano Salvioli,3 and Nino Basaglia1
1Neuroscience and Rehabilitation Department, Ferrara University Hospital, 44100 Ferrara, Italy
2Center of Neuromodulation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02129, USA
3School of Physiotherapy, University of Ferrara, 44100 Ferrara, Italy
Received 23 October 2015; Revised 18 January 2016; Accepted 6 March 2016
Academic Editor: Juan C. Moreno
Copyright © 2016 Sofia Straudi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Objective. The aim of this exploratory pilot study is to test the effects of bilateral tDCS combined with upper extremity robot-assisted therapy (RAT) on stroke survivors. Methods. We enrolled 23 subjects who were allocated to 2 groups: RAT + real tDCS and RAT + sham-tDCS. Each patient underwent 10 sessions (5 sessions/week) over two weeks. Outcome measures were collected before and after treatment: (i) Fugl-Meyer Assessment-Upper Extremity (FMA-UE), (ii) Box and Block Test (BBT), and (iii) Motor Activity Log (MAL). Results. Both groups reported a significant improvement in FMA-UE score after treatment (p <0.01). No significant between-groups differences were found in motor function. However, when the analysis was adjusted for stroke type and duration, a significant interaction effect (p <0.05) was detected, showing that stroke duration (acute versus chronic) and type (cortical versus subcortical) modify the effect of tDCS and robotics on motor function. Patients with chronic and subcortical stroke benefited more from the treatments than patients with acute and cortical stroke, who presented very small changes. Conclusion. The additional use of bilateral tDCS to RAT seems to have a significant beneficial effect depending on the duration and type of stroke. These results should be verified by additional confirmatory studies.
2. Methods
This double-blinded exploratory RCT pilot study (NCT01828398) has been reviewed by the Ferrara University Hospital Ethics Committees. Written informed consent was obtained before all procedures. Inclusion criteria were as follows: (i) age (18–75 y); (ii) diagnosis of first stroke (ischemic or hemorrhagic verified by brain imaging); (iii) upper limb motor impairments verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE); (iv) trunk control defined as a score >50 on the Trunk Control Test (TCT) [27]; (v) adequate understanding of verbal and written information, sufficient to complete the tests. Exclusion criteria were as follows: (i) impaired cognitive functioning (score less than 24 on the Mini Mental Status Examination); (ii) intracranial metal implants that can be stimulated, incorrectly positioned, or overheated by the electric current; (iii) other neurological or psychiatric disorders; (iv) severe cardiopulmonary, renal, and hepatic diseases; (v) pregnancy. Patients enrolled were randomized in blocks of 4, stratified by the time distance from stroke (subacute: <6 months; chronic phase: >6 months), using a program available online (http://www.randomization.com/). They were allocated into two different treatment groups: upper extremity robot-assisted training + real-tDCS (experimental group) or upper extremity robot-assisted training + sham-tDCS (control group). Every patient received five sessions/week (Mon-Fri) over two weeks (10 sessions).
3. Results
We enrolled 23 stroke survivors; 12 were allocated to real-tDCS + RAT group and 11 to sham-tDCS + RAT group. The flow diagram of the study is reported in Figure 1.
Figure 1: CONSORT study flow diagram.
Demographic, stroke, and functional baseline characteristics are summarized in Table 1. The two groups were similar in demographics (sex) and functional (FMA-UE, BBT, and MAL) and stroke parameters (onset, rehabilitation phase, stroke etiology, lesion type, and side hemisphere), except for age ().
Table 1: Clinical and demographic characteristics.
In our initial analysis of comparing differences between active and sham-tDCS groups (univariate analysis), we found no significant differences. We then performed adjusted analysis and also tested for the interaction effects so as to test for potential effect modifiers. The effects of demographic and stroke characteristics on motor recovery were explored. Sex, stroke etiology, and side of the affected hemisphere were not predictors of motor improvements in our sample. Conversely, recovery stage in sham-tDCS group (F=9.20, df = 1,9;p <0.05; adjusted R² = 0.45 ) and stroke location in real-tDCS group (F= 8.48, df = 1,10;p <0.05 ; adjusted R² = 0.40 ) were confirmed as predictors of motor recovery by a linear regression approach. A three-way ANOVA confirmed a significant main effect of recovery stage on motor function (p <0.01) and a significant interaction effect (p <0.01) of treatment (real- and sham-tDCS) and stroke location (subcortical and cortical). Treatment and recovery stage interaction effect was close to reaching statistical significance (p <0.10). Based on these findings, a 3-point composite variable was created considering recovery stage and stroke location: patients were grouped as chronic subcortical stroke (n=6), subacute subcortical or chronic cortical stroke (n=11), or cortical subacute stroke (n=6). A positive interaction between received treatment and this composite variable has been shown to be significant (p <0.05). Post hoc analysis, considering motor recovery, revealed that there were significant differences in FMA-UE in both groups (real-tDCS group:z= -295,p= 0.003 ; sham-tDCS group:z= -280 ,p= 0.004). Gross motor function (BBT) and real-world arm functional use (MAL) were improved only in real-tDCS group (BBT:z= -2.29;p= 0.002; MAL-AOM:z= -2.21;p= 0.002; MAL-QOM:z= -2.21;p= 0.002). No between-group differences were highlighted among all outcome measures (see Table 2).
Full text at the link.
Use the labels in the right column to find what you want. Or you can go thru them one by one, there are only 29,120 posts. Searching is done in the search box in upper left corner. I blog on anything to do with stroke.DO NOT DO ANYTHING SUGGESTED HERE AS I AM NOT MEDICALLY TRAINED, YOUR DOCTOR IS, LISTEN TO THEM. BUT I BET THEY DON'T KNOW HOW TO GET YOU 100% RECOVERED. I DON'T EITHER, BUT HAVE PLENTY OF QUESTIONS FOR YOUR DOCTOR TO ANSWER.
Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.
What this blog is for:
My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.
Tuesday, April 5, 2016
tDCS and Robotics on Upper Limb Stroke Rehabilitation: Effect Modification by Stroke Duration and Type of Stroke
Labels:
Fugl-Meyer,
tDCS,
upper limb
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