recoveriX for Multiple Sclerosis
Study Results

Upper & Lower Extremity Treatment for Multiple Sclerosis

Multiple Sclerosis (MS) is the most common chronic inflammatory disease of the central nervous system. It can lead to physical disability, cognitive impairment, and generally decreased quality of life [1]. While there are many symptoms associated with MS, fatigue may be the most debilitating, resulting in impairment of activities of daily living or loss of employment [2]. Other common symptoms are paresis, spasticity, and increased energy cost during walking, leading to diminished walking ability and walking speed [3, 4].

The efficacy of recoveriX was shown in a group of 25 people with MS. The following clinical outcome measures were utilized:

6-Minute Walk Test (6MWT) was the primary outcome measure of the study as it is the most common clinical scale in MS literature due to having high reproducibility and reliability [4]. The 6MWT measures the distance in meters a patient is able to walk at a comfortable speed within six minutes.

Timed Up & Go (TUG) assesses functional mobility by measuring the time, in seconds, it takes a patient to get up from a chair, walk 3 meters, turn around and sit down again. The TUG test is known to be valid and reliable for assessing people with MS [5,6].

Timed 25-Foot Walk (T25FW) assesses walking speed by measuring the time, in seconds, it takes a patient to walk 25 feet (i.e., 7.62 m). It is a reliable and recommended scale for assessing people with MS [7,8].

Modified Ashworth Scale (MAS) assesses spasticity in both ankle and knee joints with higher value reflecting greater spasticity. Here the scores from all four joints were summed up to one total MAS score.

Multiple Sclerosis Impact Scale (MSIS-29) is a questionnaire quantifying the physical and psychological impact of MS, with lower values reflecting less impairment. The MSIS-29 is reliable and recommended to be used as a clinical scale [9].

Modified Fatigue Impact Scale (MFIS) is a questionnaire quantifying the impact of fatigue on patients’ daily life which was shown to be reliable [10, 11].

The table below shows the baseline characteristics of the study population, with 19 of them being female. This relatively high percentage of female study participants is to be expected as women are roughly 3 times more likely to be diagnosed with MS [1].

After training with recoveriX for 30 therapy sessions, patients improved highly significantly in their 6MWT performance. Specifically, they were able to walk 39.4 meters farther after the treatment in comparison to before. For reference, the minimally important change in 6MWT performance that people with MS perceive as important is 19.7 meters [12, 13]. In other words, this minimally important change was exceeded by double the amount. In percentages patients improved in their walking ability by 19% on average.

The table and figure below show the numerical change (i.e., after – before) and percentage improvement for the secondary clinical outcome measures, which all reflected significant improvements. Patients improved in their functional mobility and walking speed, as well as spasticity. Additionally, they reported to be less affected by MS in ADLs and even less fatigued.

References

[1] McGinley, M. P., Goldschmidt, C., & Rae-Grant, A. (2021). Diagnosis and Treatment of Multiple Sclerosis. JAMA, 325(8), 765. 

[2] Fox, R. J., Bacon, T., Chamot, E., Salter, A., Cutter, G., Kalina, J., & Kister, I. (2015). Prevalence of multiple sclerosis symptoms across lifespan: data from the NARCOMS Registry, 6(2), 178.

[3] Stella, A. B., Morelli, M. B., Giudici, F., Sartori, A., Manganotti, P., & Di Prampero, P. E. (2020). Comfortable walking speed and energy cost of locomotion in patients with multiple sclerosis. European Journal of Applied Physiology, 120(3), 551–566. 

[4] Goldman, M. D., Marrie, R. A., & Cohen, J. A. (2008). Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Multiple Sclerosis Journal, 14(3), 383–390. 

[5] Sebastião, E., Sandroff, B. M., Learmonth, Y. C., & Motl, R. W. (2016). Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Archives of Physical Medicine and Rehabilitation, 97(7), 1072–1077. 

[6] Christopher, A., Kraft, E., Olenick, H., Kiesling, R., & Doty, A. (2019). The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review. Disability and Rehabilitation, 43(13), 1799–1813. 

[7] Kalinowski, A., Cutter, G., Bozinov, N., Hinman, J. M., Hittle, M., Motl, R. W., Odden, M. C., & Nelson, L. M. (2021). The timed 25-foot walk in a large cohort of multiple sclerosis patients. Multiple Sclerosis Journal, 28(2), 289–299.

[8] Motl, R. W., Cohen, J. A., Benedict, R. H., Phillips, G., LaRocca, N. G., Hudson, L. D., & Rudick, R. A. (2017). Validity of the timed 25-foot walk as an ambulatory performance outcome measure for multiple sclerosis. Multiple Sclerosis Journal, 23(5), 704–710. 

[9] Riazi, A., Hobart, J., Lamping, D. L., Fitzpatrick, R., & Thompson, A. S. (2002). Multiple Sclerosis Impact Scale (MSIS-29): reliability and validity in hospital based samples. Journal of Neurology, Neurosurgery & Psychiatry, 73(6), 701–704. 

[10] Riemenschneider, M., Trénel, P., Nørgaard, M., & Boesen, F. (2022). Multimethodological validation of the modified fatigue impact scale in a Danish population of people with Multiple Sclerosis. Multiple Sclerosis and Related Disorders, 65, 104012. 

[11] Chung, Y. H., Jeong, A., Kim, B. Y., Park, K., & Min, J. (2022). Validity and reliability of Korean version of Modified Fatigue Impact Scale (MFIS) for Korean patients with Multiple Sclerosis. Multiple Sclerosis and Related Disorders, 62, 103811. 

[12] Mokkink, L. B., Terwee, C. B., Patrick, D. L., Alonso, J. A., Stratford, P. W., Knol, D. L., Bouter, L. M., & De Vet, H. C. (2010). The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. Journal of Clinical Epidemiology, 63(7), 737–745. 

[13] Oosterveer, D. M., Van Den Berg, C., Volker, G., Wouda, N. C., Terluin, B., & Hoitsma, E. (2022). Determining the minimal important change of the 6-minute walking test in Multiple Sclerosis patients using a predictive modelling anchor-based method. Multiple Sclerosis and Related Disorders, 57, 103438.