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

K

Klinik Valens

Status

Unknown

Conditions

Rehabilitation

Treatments

Device: GaitUp Physilog 5

Study type

Observational

Funder types

Other

Identifiers

NCT03769636
BASEC Nr. 2017-00728

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Central trial contact

Jan Kool, PhD; Roger April, PT

Data sourced from clinicaltrials.gov

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