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

NCT03769636 | Unknown

• 1 other identifier: BASEC Nr. 2017-00728
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Keywords

Multiple Sclerosis; In-patient rehabilitation; All day life activities; Walking capacity; Fatigue; Quality of life

Outcome Measures

Primary Outcomes (7)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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 Outcomes (3)

• Changes in self-rated fatigue

  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).

• Changes in self-rated health-related quality of life: EQ-5D

  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).

• Changes in self-rated walking capacity

  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 (4)

• 10 meter walking test (10TW)

  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).

• Timed up and go (TUG)

  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).

• 2 minutes walking test (2MWT)

  2MWT will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3).

Interventions

GaitUp Physilog 5 DEVICE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Klinik Valens: lead

Study Sites (1)

Klinik Valens

Valens, St.Gallen, 7313, Switzerland

RECRUITING

Related Publications (9)

• 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.

  PMID: 18505775 BACKGROUND

• 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.

  PMID: 26281954 BACKGROUND

• 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.

  PMID: 27216225 BACKGROUND

• 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.

  PMID: 22772357 BACKGROUND

• 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.

  PMID: 26070975 BACKGROUND

• 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.

  PMID: 24314677 BACKGROUND

• 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.

  PMID: 25455299 BACKGROUND

• 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.

  PMID: 26472942 BACKGROUND

• 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.

  PMID: 28285547 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Roger April, PT

CONTACT

0041786141712; roger.april@kliniken-valens.ch

Jan Kool, PhD

CONTACT

0041813031403; jan.kool@kliniken-valens.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 7, 2018
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)