中風患者上下肢運動康復

recoveriX 科學結果

上肢治療

一項針對 52 名患者的小組研究顯示了 recoveryiX 的療效。完成治療的 51 名患者上肢運動功能和痙攣狀態均有顯著改善。此外,發現由 recoveryiX 促進的改進在本質上是持久的。中風後的時間、年齡和基線損傷不影響患者的運動功能改善。經歷的功能改善可以通過中樞神經系統的神經可塑性變化來解釋。

recoveryiX PRO 研究的主要結果測量是上肢 Fugl-Meyer 評估 (FMA-UE)。 FMA-UE 被推薦用於評估中風後的上肢運動功能 [1,2],並且具有出色的評分者間可靠性 [3,4]。

recoverix stroke rehabiliation

下表顯示了完成治療的 51 名患者的患者特徵,其中 23 名是女性。

Median Range
年齡(歲) 62.0 13-86 years
中風後的時間(月) 36.5 3 months – 31 years
PRE 中的 FMA-UE(分) 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 [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 Improvements in the scientific study recoverix

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

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.

FMA-UE Improvements in the scientific study recoverix

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 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.

 

References

[1] Gladstone, D. J., Danells, C. J., & Black, S. E. (2002). The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabilitation and Neural Repair, 16(3), 232–240. doi:10.1177/15459680240110517

[2] Bushnell, C., Bettger, J. P., Cockroft, K. M., Cramer, S. C., Edelen, M. O., Hanley, D., … Yenokyan, G. (2015). Chronic stroke outcome measures for motor function intervention trials: Expert panel recommendations. Circulation. Cardiovascular Quality and Outcomes, 8(6 Suppl 3), S163-9. doi:10.1161/CIRCOUTCOMES.115.002098

[3] Duncan, P. W., Propst, M., & Nelson, S. G. (1983). Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Physical Therapy, 63(10), 1606–1610. doi:10.1093/ptj/63.10.1606

[4] Sanford, J., Moreland, J., Swanson, L. R., Stratford, P. W., & Gowland, C. (1993). Reliability of the Fugl-Meyer assessment for testing motor performance in patients following stroke. Physical Therapy, 73(7), 447–454. doi:10.1093/ptj/73.7.447

[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

[9] Perera, S., Mody, S. H., Woodman, R. C., & Studenski, S. A. (2006). Meaningful change and responsiveness in common physical performance measures in older adults. Journal of the American Geriatrics Society, 54(5), 743–749. doi:10.1111/j.1532-5415.2006.00701.x

[10] Peurala, S. H., Tarkka, I. M., Pitkänen, K., & Sivenius, J. (2005). The effectiveness of body weight-supported gait training and floor walking in patients with chronic stroke. Archives of Physical Medicine and Rehabilitation, 86(8), 1557–1564. doi:10.1016/j.apmr.2005.02.005