Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03769636
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
April Roger, Klinik Valens

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.


Condition or disease Intervention/treatment
Rehabilitation Device: GaitUp Physilog 5

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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).



Primary Outcome Measures :
  1. Changes in physical activity: Locomotion [ Time Frame: 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). ]

    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%.


  2. Changes in physical activity: Non-locomotion [ Time Frame: 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). ]

    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%.


  3. Changes in physical activity: Level walking [ Time Frame: 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). ]

    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%.


  4. Changes in physical activity: Up walking [ Time Frame: 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). ]

    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%.


  5. Changes in physical activity: Down walking [ Time Frame: 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). ]

    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%.


  6. Changes in physical activity: Maximum steps [ Time Frame: 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). ]

    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.


  7. Changes in physical activity: Steps per hour [ Time Frame: 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). ]

    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.



Secondary Outcome Measures :
  1. Changes in self-rated fatigue [ Time Frame: 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). ]

    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

  2. Changes in self-rated health-related quality of life: EQ-5D [ Time Frame: 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). ]

    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

  3. Changes in self-rated walking capacity [ Time Frame: 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). ]

    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


Other Outcome Measures:
  1. 10 meter walking test (10TW) [ Time Frame: 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). ]
    10TW will be assessed to see changes in walking speed.

  2. Timed up and go (TUG) [ Time Frame: 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). ]
    TUG will be assessed to see changes in equilibrium and walking abilities.

  3. 2 minutes walking test (2MWT) [ Time Frame: 2MWT will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3). ]
    2MWT will be assessed to see changes in walking speed and distance

  4. Stair measure test (ST) [ Time Frame: ST will be assessed in the first week of rehabilitation (T2) and in the third week of rehabilitation (T3). ]
    ST will be assessed to see changes in speed and walking abilities on stairs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769636


Contacts
Layout table for location contacts
Contact: Roger April, PT 0041786141712 roger.april@kliniken-valens.ch
Contact: Jan Kool, PhD 0041813031403 jan.kool@kliniken-valens.ch

Locations
Layout table for location information
Switzerland
Klinik Valens Recruiting
Valens, St.Gallen, Switzerland, 7313
Contact: Roger April, PT    0041786141712    roger.april@kliniken-valens.ch   
Sponsors and Collaborators
Klinik Valens

Publications:

Layout table for additonal information
Responsible Party: April Roger, Pricipal Investigator, Klinik Valens
ClinicalTrials.gov Identifier: NCT03769636     History of Changes
Other Study ID Numbers: BASEC Nr. 2017-00728
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by April Roger, Klinik Valens:
Multiple Sclerosis
In-patient rehabilitation
All day life activities
Walking capacity
Fatigue
Quality of life