Standardized Ambulatory Neurorehabilitation Program for Patients With
Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Early treatment group
Placebo
- Late treatment group
What it measured
Main measures
Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29)
2 - 4 months
Quality of life (reported by participants)
Other measures (7)
Change from baseline in Coin Rotation Task (Heldner et al. 2014)
0 - 2 - 4 months
Arm and hand functionChange from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007)
0 - 2 - 4 months
Walking and mobilityChange from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988)
0 - 2 - 4 months
Disability progressionArm and hand functionChange from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014)
0 - 2 - 4 months
Disability progressionWalking and mobilityChange from baseline in EDSS
0 - 2 - 4 months
Disability progressionChange from baseline in Rand 36
0 - 2 - 4 months
PainQuality of life (reported by participants)Change from baseline in Fatigue Severity Scale
0 - 2 - 4 months
Fatigue
Who could take part
Relapsing and progressive · 18 to 75
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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.Results
Lehmann I, Thaler I, Luder G, Damm U, Walti C, Steinheimer S, Verra ML, Muri RM, Nyffeler T, Vanbellingen T, Kamm CP. Standardized, comprehensive, hospital-based circuit training in people with multiple sclerosis: results on feasibility, adherence and satisfaction of the training intervention. Eur J Phys Rehabil Med. 2020 Jun;56(3):279-285. doi: 10.23736/S1973-9087.20.06191-2. Epub 2020 Mar 30.Background
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.Background
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. doi: 10.1136/jnnp.2005.064584.
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History
Started
Feb 2016
Main results due
Feb 2019
Finished
Feb 2019