Changes in Physical Activity in All Day Life in People With MS Before and After Rehabilitation

Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03769636
• Other study ID #: BASEC Nr. 2017-00728
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: October 2019

Study information

• Verified date: December 2018
• Source: Klinik Valens
• Contact: Roger April, PT
• Phone: 0041786141712
• Email: roger.april[@]kliniken-valens.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Device:
• GaitUp Physilog 5
The primary outcomes are measured by the Physilog 5 (physical activity) at four different periods (T1-T4). Physilog 5 is worn for 4 weeks in total. The secondary outcomes are fatigue, measured by FSMC (fatigue scale for motor and cognitive functions questionnaire), self-rated health-related quality of life, measured by the EQ-5D (health-questionnaire) and self-rated walking capacity, measured by the MSWS-12 (Twelve Item MS Walking Scale).

Locations

Country	Name	City	State
Switzerland	Klinik Valens	Valens	St.Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Valens

Country where clinical trial is conducted

Switzerland, 

References & Publications (9)

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. Review. — View 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. Review. — View 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. Review. — View Citation

Fjeldstad, C., A.S. Fjeldstad, and G. Pardo, Use of Accelerometers to Measure Real-Life Physical Activity in Ambulatory Individuals with Multiple Sclerosis: A Pilot Study. Int J MS Care, 2015. 17(5): p. 215-20.

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. Review. — View Citation

Heesen C, Böhm 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	10 meter walking test (10TW)	10TW will be assessed to see changes in walking speed.	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).
Other	Timed up and go (TUG)	TUG will be assessed to see changes in equilibrium and walking abilities.	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).
Other	2 minutes walking test (2MWT)	2MWT will be assessed to see changes in walking speed and distance	2MWT will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).
Other	Stair measure test (ST)	ST will be assessed to see changes in speed and walking abilities on stairs.	ST will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).
Primary	Changes in physical activity: Locomotion	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Locomotion: Percentage of locomotion (walking) per day The maximum value is 100%, the minumum value is 0%.	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).
Primary	Changes in physical activity: Non-locomotion	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Non-locomotion: Percentage of non-locomotion (sitting, standing, lying) per day The maximum value is 100%, the minumum value is 0%.	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).
Primary	Changes in physical activity: Level walking	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Level walking: Percentage of level walking per day The maximum value is 100%, the minumum value is 0%.	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).
Primary	Changes in physical activity: Up walking	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Up walking: Percentage of up walking per day The maximum value is 100%, the minumum value is 0%.	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).
Primary	Changes in physical activity: Down walking	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Down walking: Percentage of down walking per day The maximum value is 100%, the minumum value is 0%.	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).
Primary	Changes in physical activity: Maximum steps	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Maximum steps: Maximal number of continuous steps in one walking bout (a walking bout is defined as walking more than two continuous steps).; The maximum value is open, the minimum value is zero.	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).
Primary	Changes in physical activity: Steps per hour	The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life in patients with MS (EDSS 2.0-6.5) 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 following parameter represents the walking in daily life: - Steps per hour: Number of steps during all recorded walking bouts (the values are normalised per worn hours).; The maximum value is open, the minimum value is zero.	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	Changes in self-rated fatigue	Fatigue will be measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC). The FSMC is a 20-points-questionnaire with ten questions about cognitive fatigue and ten questions about motor fatigue. The questions are rated on a 5-point Likert-scale from 1 (does not apply at all) to 5 (applies completely). The total score ranges from a minimum of 20 points to a maximum of 100 points, sub-scores for cognitive and motor fatigue range from a minimum of 10 points to a maximum of 50 points. Higher scores indicate a higher perception of fatigue.; The following comparisons are executed: Comparison between T1 and T2; Comparison between T2 and T3; Comparison between T2 and T4	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).
Secondary	Changes in self-rated health-related quality of life: EQ-5D	Self-rated health will be measured by the questionnaire "health- related quality of life" (EQ-5D). The EQ-5D is a fife-points questionnaire about the topics "mobility", "self-care", "usual-activities", "pain/discomfort" and "anxiety/depression". The questions are rated with the following possibilities: "no problems", "some problems" and "extreme problems". On the basis of standardized calculations a index value is generated. The value ranges form zero to one. Higher values indicate a higher health-related quality of life.; The following comparisons are executed: Comparison between T1 and T2; Comparison between T2 and T3; Comparison between T2 and T4	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).
Secondary	Changes in self-rated walking capacity	Self-rated walking capacity will be measured by the 12-Item MS Walking Scale (MSWS-12). The MSWS-12 is a twelve-points questionnaire to represent the impact of MS on walking capacity. The questions are rated on a five-point Likert-scale from 1 (not at all) to 5 (extremely). The total score ranges from a minimum of 12 points to a maximum of 60 points. Higher scores indicate a higher impact of MS on walking capacity.; The following comparisons are executed: Comparison between T1 and T2; Comparison between T2 and T3; Comparison between T2 and T4	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).