recoveriX for Stroke
Study Results

Upper Extremity Therapy

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.

The baseline impairment of patients was on median 19.0 points with 35, 9 and 7 patients being severely, moderately and mildly impaired, respectively [5].
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) [5] 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.

FMA-UE improvement for the different patient groups shown in mean and 95% Confidence Interval. ALL: all 51 patients who participated in the study. SEVERE: severely impaired patients (n=35). MODERATE: moderately impaired patients (n=9). Mild…mildly impaired patients (n=7)

Page et al. (2012) [6] 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!

Additionally, the following clinical scales show significant improvements [7,8]:

• Barthel Index
• Modified Ashworth Scale for Wrist and Fingers
• Box and Block Test of the affected and healthy hand
• 9-Hole Peg test for the healthy hand
• Fahn Tremor Rating Scale of the affected and healthy hand
• Montreal Cognitive Assessment
• Stroop Color-Word Test

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

Lower Extremity Therapy

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) [9]. 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:

• Barthel Index
• Modified Ashworth Scale for Ankle
• Range of Motion in Ankle
• Manual Muscle Test for Knee and Ankle
• Timed Up and Go test
• Montreal Cognitive Assessment

Comparison of recoveriX with other treatments

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 [10]. 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.

10MWT Improvement reflecting the increase in GAIT speed in m/s for EGAIT-EE and recoveriX treatment.

recoveriX is compared to many control groups

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.

Clinical Scales and Tests

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.

• The Barthel Index is a subjective questionnaire in which patients rate their performance in Activities of Daily Living.
• The Modified Ashworth Scale assesses spasticity of different joints of the affected side.
• The Box and Blocks Test assess hand dexterity.
• The 9-Hole Peg Test assesses finger dexterity.
• The Fahn Tremor Rating Scale assesses the tremor degree of the upper extremity.
• The Montreal Cognitive Assessment assesses cognitive function and impairment.
• The Stroop Color-Word Test assesses the ability to process two cognitively interfering stimuli (see Stroop Effect).
• The 10-Meter Walk Test assesses the gait speed.
• The Manual Muscle Test assesses muscle strength and function.
• The Timed Up and Go Test assess the mobility and requires balance and coordination.

The benefit of performing both the upper and lower extremity treatment

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:

• Barthel Index
• Upper and Lower Fugl-Meyer Assessment
• Modified Ashworth Scale of the ankle joint
• Range of motion of the ankle and knee joint
• Manual Muscle Test of the knee and ankle
• Timed Up and Go Test
• 10-Meter Walk Test

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.

References

Sebastián-Romagosa, M., Cho, W., Ortner, R., Sieghartsleitner, S., Von Oertzen, T.J., Kamada, K., Laureys, S., Allison, B.Z. and Guger, C., Brain-Computer Interface Treatment for Gait Rehabilitation in Stroke Patients. Frontiers in Neuroscience, 17, p.1256077. doi:10.3389/fnins.2023.1256077

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[5] Woytowicz, E. J., Rietschel, J. C., Goodman, R. N., Conroy, S. S., Sorkin, J. D., Whitall, J., & McCombe Waller, S. (2017). Determining levels of upper extremity movement impairment by applying a cluster analysis to the Fugl-Meyer assessment of the upper extremity in chronic stroke. Archives of Physical Medicine and Rehabilitation, 98(3), 456–462. doi:10.1016/j.apmr.2016.06.023

[6] Page, S. J., Fulk, G. D., & Boyne, P. (2012). Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. Physical Therapy, 92(6), 791–798. doi:10.2522/ptj.20110009

[7] Sebastián-Romagosa, M., Udina, E., Ortner, R., Dinarès-Ferran, J., Cho, W., Murovec, N., … Guger, C. (2020). EEG biomarkers related with the functional state of stroke patients. Frontiers in Neuroscience, 14, 582. doi:10.3389/fnins.2020.00582

[8] Sebastián-Romagosa, M., Cho, W., Ortner, R., Murovec, N., Von Oertzen, T., Kamada, K., … Guger, C. (2020). Brain computer interface treatment for motor rehabilitation of upper extremity of stroke patients-A feasibility study. Frontiers in Neuroscience, 14, 591435. doi:10.3389/fnins.2020.591435

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