Standardized Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis

NCT02440516 | Completed DMC

• 1 other identifier: 2015_04_29
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Standardized; Physical therapy; occupational therapy; quality of life; disability; activities of daily living; ambulatory therapy; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in Coin Rotation Task (Heldner et al. 2014)

  0 - 2 - 4 months

• Change from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007)

  0 - 2 - 4 months

• Change from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988)

  0 - 2 - 4 months

• Change from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014)

  0 - 2 - 4 months

• Change from baseline in EDSS

  0 - 2 - 4 months

Study Arms (2)

Neurorehabilitation program

ACTIVE COMPARATOR

Standardized comprehensive ambulatory neurorehabilitation program

Other: Early treatment group

Waiting list

PLACEBO COMPARATOR

Waiting list

Other: Late treatment group

Interventions

Early treatment group OTHER

Physical- and occupational Therapy

Neurorehabilitation program

Late treatment group OTHER

Waiting list - then Physical- and occupational Therapy

Waiting list

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Department of Neurology, Bern University Hospital

Bern, 3010, Switzerland

Location

Department of Neurology, Cantonal hospital Luzern

Lucerne, 6000, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 25095894 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.

  PMID: 16227547 BACKGROUND

• 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.

  PMID: 22825702 RESULT

• 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.

  PMID: 32225136 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christian P Kamm, MD

  Department of Neurology, Cantonal hospital Luzern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 12, 2015
• Study Start: February 1, 2016
• Primary Completion: February 26, 2019
• Study Completion: February 26, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

CH (2)