The efficacy of recoveriX was shown in a group study of 52 patients. The 51 patients who finished the treatment showed highly significant improvements in upper extremity motor function and spasticity. Furthermore, the improvements facilitated by recoveriX were found to be long lasting in nature. Time since stroke, age and baseline impairment did not affect the motor function improvements experienced by patients. The functional improvements experienced can be explained by neuroplastic changes in the central nervous system.
The primary outcome measure of the recoveriX PRO study was the upper extremity Fugl-Meyer Assessment (FMA-UE). The FMA-UE is recommended for evaluating upper extremity motor function after stroke [1,2] and has excellent inter-rater reliability [3,4].
The table below shows the patient characteristics of the 51 patients who finished the treatment, with 23 of them being female.
|Age (years)||62.0||13-86 years|
|Time Since Stroke (months)||36.5||3 months – 31 years|
|FMA-UE in PRE (points)||19.0||3-59 points|
The baseline impairment of patients was on median 19.0 points with 35, 9 and 7 patients being severely, moderately and mildly impaired, respectively .
Patients improved on average by 4.8 points in FMA-UE. Performing a statistical test (two-tailed paired t-test) resulted in a highly significant difference in mean FMA-UE scores before and after recoveriX treatment.
If one splits patients by their degree of impairment according to Woytowicz et al. (2017)  we observed that severely impaired patients improved by 3.7 points, moderately impaired patients improved by 8.0 points and mildly impaired patients improved by 5.3 points. Below a figure is shown for the different patient groups.
Page et al. (2012)  defined the clinically important difference for moderately to minimally impaired patients in chronic stroke to be 4.25 to 7.25 points in FMA-UE. Clinically important difference refers to the improvement that is considered meaningful for the patient. For moderately impaired patients recoveriX achieved 8.0 points, which is greater than the clinically important difference. For minimally impaired patients recoveriX achieved 5.3 points, which is in the range of the clinically important difference.
In comparison, studies using just FES (i.e., without a BCI) reached a mean improvement of 3.9 points in FMA-UE.
Patients who are able to control the recoveriX system very well (median classification accuracy >80%) improved by 6.5 points, whereas people who had a median classification accuracy <80% improved by 2.3 points. This shows that active engagement and motivation are of importance, when training with the recoveriX system. Importantly, the ability to control the recoveriX system is independent from baseline impairment!
Note that in the study we did not observe a significant improvement in 9-Hole Peg test for the affected hand. This is because only 9 out of 51 patients could even perform this test, because it requires substantial fine motor skills
The efficacy of our recoveriX lower extremity therapy was investigated in 25 stroke patients. As three patients withdrew their participation 22 patients remained with 9 of them being female. 21 patients were in their chronic phase and one was in their subacute phase. The primary outcome measure was gait speed, assessed using the 10-Meter Walk Test (10MWT). All patients performed 25 sessions of one hour of recoveriX therapy distributed across 3 times per week.
Patients’ 10MWT improved significantly by 1.0 second. In other words, patients were able to complete the 10MWT quicker after the recoveriX therapy. In terms of gait speed patients also showed a significant improvement by 0.16 m/s with the mean improvement in gait speed being 0.19 m/s.
These results show that patients’ gait speed, assessed by the 10MWT, improved significantly. In fact, this improvement exceeds the substantial meaningful change defined by Perera et al. (2006) . Patients show a significant improvement in gait speed after 21 sessions (analyzed using a repeated measure analysis). Therefore, the protocol based on 25 sessions distributed across 3 times per week, was found to be a good dosage.
Additionally, the following clinical scales show significant improvements:
We chose to compare our recoveriX lower extremity therapy with one of the most effective treatments in the literature for gait rehabilitation in stroke patients: Electromechanical Gait Training with End Effector devices (EGAIT-EE). EGAIT-EE was identified to be the most effective by performing a meta-analysis. The meta-analysis originally included 95 randomized controlled trials with a total of 4458 patients. The primary measure used to evaluate the walking ability was the gait speed. The EGAIT-EE group improved significantly in gait speed compared with the control group by 0.15 m/s on average (P < 0.001).
Patients in their chronic phase showed a change in gait speed of 0.11 m/s in the EGAIT-EE group . In comparison for recoveriX we observed an improvement of 0.19 m/s. Importantly, recoveriX does not need the use of a body weight support system as patients are seated during the recoveriX therapy. Therefore, the risk of falls is completely eliminated, while patients can still train their gait patterns and increase their motor functions, gait speed, coordination and balance.
Many people ask us why we do not have control groups in these studies. The simple answer is that a medical product has to be compared with many other technologies and scientific results on the market and this must be updated every year. For medical products a clinical evaluation has to be performed in order to get the medical approval from a notified body. This clinical evaluation is reviewed by the clinical evaluation center of the notified body, which is the unit responsible for bringing medical products to the market that are safe and effective.
The recoveriX system was compared with many independent studies using different techniques. Important to note here is that in this way recoveriX was compared to many different control groups and scientific study results and that a medical product gets the certification only if it is effective and safe. Finally, this clinical evaluation showed that recoveriX is effective and safe.
The Upper Extremity Fugl-Meyer Assessment (FMA-UE) is an assessment for evaluating and quantifying motor function of the upper extremity in stroke patients. The scale ranges from 0 to 66 points, with 66 points being the best motor function a patient can have.
Is it beneficial to perform another recoveriX treatment block (i.e., 25 therapy sessions for stroke) after finishing the first recoveriX treatment block? The short answer is Yes, because further motor function improvements are still possible especially if you have responded well to the first recoveriX treatment block. As always, we have the data to back up this conclusion, so let’s look at it.
Eighteen stroke patients participated in at least one recoveriX treatment block, before they started their recoveriX lower extremity treatment block (i.e., foot therapy). Across their previous treatment block, they improved significantly by 4.8 points in upper extremity motor function on average. Then these 18 stroke patients participated in the recoveriX lower extremity treatment block and we observed significant improvements in the following clinical scales:
Taking a closer look at the walking velocity, which is assessed using the 10-Meter Walk Test, we could observe an improvement by 0.14 m/s on average. In other words, the patients could walk 0.5 km/h faster after their recoveriX lower extremity treatment block.
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