Multiple Sclerosis Clinical Trial
— "MS-Fit"Official title:
Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial
Verified date | February 2019 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS)
and the most common cause of non-traumatic disability in young adults in western countries.
Despite increasing therapeutic options to ameliorate the disease course, most patients suffer
from persistent neurological deficits over time.
Disability in MS has a negative impact on patients life's impairing activities of daily
living (ADL) and quality of life (QoL) and leading to loss of work and the need providing
care. This results in tremendous socioeconomic burden.
Disease-modifying treatments prevent disability progression in variable extent. However no
drugs are available ameliorate persistent disability in MS. Therefore, exercise training as
well as physical and occupational therapies are important in the symptomatic treatment of MS.
Physical and occupational therapy is usually performed close to patients home by therapist
with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory
neurorehabilitation program, integrating task oriented circuit training for MS patients to
improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital
settings.
Status | Completed |
Enrollment | 65 |
Est. completion date | February 26, 2019 |
Est. primary completion date | February 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) - Age between 18 and 75 years - Written informed consent - Patient complains about MS related disability that affects ADL and/or QoL Exclusion Criteria: - A relapse that started within 60 days prior to screening - Rapidly progressive disease - Any disease/condition that causes neurological deficits or disability besides MS - A history of drug abuse in the 12 months prior to screening |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Neurology, Bern University Hospital | Bern | |
Switzerland | Department of Neurology, Cantonal hospital Luzern | Luzern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. How responsive is the Multiple Sclerosis Impact Scale (MSIS-29)? A comparison with some other self report scales. J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1539-43. — View Citation
Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30. Review. — View Citation
Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29) | The Multiple Sclerosis Impact Scale (MSIS-29) is valid and reliable (ICC 0.80 - 0.87) in measuring the impact of MS on ADL.It contains 29 items comprising to a physical (MSIS-29 physical) and psychological impact scale (MSIS-29 psychological). All items are scored from 'not at all' to 'extremely' on a five-point Likert scale. | 2 - 4 months | |
Secondary | Change from baseline in Coin Rotation Task (Heldner et al. 2014) | The Coin Rotation Task (CRT) has been validated in assessing manual dexterity in patients with MS. Patients had to rotate a 50 Swiss Rappen coin (corresponding to a dime or 2-cent Euro coin) as fast as possible between their thumb, index and middle finger. The time to perform 20 half turns was measured twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken. | 0 - 2 - 4 months | |
Secondary | Change from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007) | The Timed Up and Go test (TUG) is a test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. | 0 - 2 - 4 months | |
Secondary | Change from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988) | The Nine Hole Peg Test (9HPT) is reliable (ICC values 0.80-0.99), valid and sensitive in detecting impaired dexterity in patients with MS. Patients were seated at a table with a shallow container holding nine pegs and a plastic block with nine empty holes. All pegs had to be put one at a time into the holes and then removed again one at a time into the shallow container. The time to complete the task was recorded twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken. | 0 - 2 - 4 months | |
Secondary | Change from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014) | The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. | 0 - 2 - 4 months | |
Secondary | Change from baseline in EDSS | 0 - 2 - 4 months | ||
Secondary | Change from baseline in Rand 36 | The RAND-36 is a license free version of the Short-Form Health Survey-36 (SF-36) containing eight scales.15 Each scale comprises two to ten items, and makes up to two summary measures. The scales measuring "physical functioning", "role-physical", "bodily pain" and "general health" form the "physical health summary score". The scales measuring "vitality", "social functioning", "role-emotional" and "mental health" form the "mental health summary score". | 0 - 2 - 4 months | |
Secondary | Change from baseline in Fatigue Severity Scale | 0 - 2 - 4 months |
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