Clinical trial NCT03769636: Changes in Physical Activity in All Day Life in People With MS Before and After Rehabilitation
Official title: Changes in Physical Activity in All Day Life (Steps, Distance, Periods, Max. Speed) in People With MS Before and After the Rehabilitation - A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rehabilitation
Keywords: Multiple Sclerosis
In-patient rehabilitation
All day life activities
Walking capacity
Fatigue
Quality of life
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigator plans to include 30 patients with multiple sclerosis with an EDSS 2.0-6.5, who come to Valens for rehabilitation between january 2018 and june 2019

Brief summary: The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.

The secondary objective is the association of changes in physical activity, self-rated walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will be analysed for disease severity of the participants.

Detailed description: Gait disorders are common in patients with multiple sclerosis (PwMS). Multidisciplinary in-patient rehabilitation conducted by specialized doctors, nurses and therapists can improve the ability to walk by tackling the problem with various approaches: by increasing strength in leg muscles, by improving balance, by increasing cardio- pulmonary fitness, by fitting walking aids, by reducing fatigue and cognitive deficits, by working out strategies to compensate for impairments, and by optimising medical treatment. The investigator's patients, who spend a lot of time (usually 2- 4 weeks) and effort for in-patient rehabilitation in Valens tell us, that this intensive therapy is usually effective and that their walking ability improves to a degree that is relevant in daily life. The scientific evidence for the effectiveness of in- patient rehabilitation is usually based on either clinical assessments of function (e.g. the 6 minute walking test) or on reports from PwMS, by using questionnaires e.g. about mobility or quality of life in daily life. Although clinical assessments provide important information about improvements of the functional capacity, they do not provide information about the impact of therapy on daily life. Patient reports, on the other hand, provide important information about the perceived impact in daily life, but the information is not objective. Objective information about the impact of rehabilitation on daily life is usually not available.

The primary objective therefore is to observe the impact of in-patient rehabilitation on physical activity in daily life using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.

The secondary objective is the association of changes in physical activity, self-rated walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will be analysed for disease severity of the participants.

Eligibility criteria: Inclusion Criteria:

* Planed rehabilitation in Valens between january 2018 and june 2019
* EDSS 2.0-6.5 (an EDSS 6.5 means the ability to walk 20 meters without resting, using constant bilateral assistance)
* German speaking
* Good function of upper limb, that the device can be fixed by participant himself
* Informed consent

Primary outcomes:
measure: Changes in physical activity: Locomotion
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in physical activity: Non-locomotion
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in physical activity: Level walking
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in physical activity: Up walking
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in physical activity: Down walking
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in physical activity: Maximum steps
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in physical activity: Steps per hour
timeFrame: Physical activity will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
Secondary outcomes:
measure: Changes in self-rated fatigue
timeFrame: Fatigue will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in self-rated health-related quality of life: EQ-5D
timeFrame: Self-rated health-related quality of life will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
measure: Changes in self-rated walking capacity
timeFrame: Self-rated waking capacity will first be measured 4-6 weeks before rehabilitation (T1) in Valens, the week right before rehabilitation (T2), the week right after rehabilitation (T3) and 2 months after rehabilitation (T4).
Other outcomes:
measure: 10 meter walking test (10TW)
timeFrame: 10TW will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the first week of rehabilitation (T2) and the third week of rehabilitation (T3).
measure: Timed up and go (TUG)
timeFrame: TUG will first be assessed 4-6 weeks before rehabilitation (T1) in Valens, the first week of rehabilitation (T2) and the third week of rehabilitation (T4).
measure: 2 minutes walking test (2MWT)
timeFrame: 2MWT will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).
measure: Stair measure test (ST)
timeFrame: ST will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).
Locations:
city: Valens
country: Switzerland
facility: Klinik Valens
state: St.Gallen
Study officials:
References:
citation: Heesen C, Bohm J, Reich C, Kasper J, Goebel M, Gold SM. Patient perception of bodily functions in multiple sclerosis: gait and visual function are the most valuable. Mult Scler. 2008 Aug;14(7):988-91. doi: 10.1177/1352458508088916. Epub 2008 May 27.
citation: Campbell E, Coulter EH, Mattison PG, Miller L, McFadyen A, Paul L. Physiotherapy Rehabilitation for People With Progressive Multiple Sclerosis: A Systematic Review. Arch Phys Med Rehabil. 2016 Jan;97(1):141-51.e3. doi: 10.1016/j.apmr.2015.07.022. Epub 2015 Aug 14.
citation: Khan F, Amatya B. Rehabilitation in Multiple Sclerosis: A Systematic Review of Systematic Reviews. Arch Phys Med Rehabil. 2017 Feb;98(2):353-367. doi: 10.1016/j.apmr.2016.04.016. Epub 2016 May 20.
citation: Beer S, Khan F, Kesselring J. Rehabilitation interventions in multiple sclerosis: an overview. J Neurol. 2012 Sep;259(9):1994-2008. doi: 10.1007/s00415-012-6577-4. Epub 2012 Jul 8.
citation: Gunn H, Markevics S, Haas B, Marsden J, Freeman J. Systematic Review: The Effectiveness of Interventions to Reduce Falls and Improve Balance in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2015 Oct;96(10):1898-912. doi: 10.1016/j.apmr.2015.05.018. Epub 2015 Jun 10.
citation: Stevens V, Goodman K, Rough K, Kraft GH. Gait impairment and optimizing mobility in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):573-92. doi: 10.1016/j.pmr.2013.07.002. Epub 2013 Sep 7.
citation: Schwartz CE, Ayandeh A, Motl RW. Investigating the minimal important difference in ambulation in multiple sclerosis: a disconnect between performance-based and patient-reported outcomes? J Neurol Sci. 2014 Dec 15;347(1-2):268-74. doi: 10.1016/j.jns.2014.10.021. Epub 2014 Oct 18.
citation: Fjeldstad C, Fjeldstad AS, Pardo G. Use of Accelerometers to Measure Real-Life Physical Activity in Ambulatory Individuals with Multiple Sclerosis: A Pilot Study. Int J MS Care. 2015 Sep-Oct;17(5):215-20. doi: 10.7224/1537-2073.2014-037.
citation: Casey B, Coote S, Donnelly A. Objective physical activity measurement in people with multiple sclerosis: a review of the literature. Disabil Rehabil Assist Technol. 2018 Feb;13(2):124-131. doi: 10.1080/17483107.2017.1297859. Epub 2017 Mar 13.