NCT01040117

Brief Summary

Balance impairment is a common and very disabling disturbance in people with Multiple Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly documented in literature. Although literature dealing with the rehabilitation of balance impairment in MS is very scant, the preliminary data reports show very promising results. The present project could have a positive impact on balance and gait ability, disability, fear of falling, risk of falls and quality of life of patients with Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

December 28, 2009

Last Update Submit

March 14, 2012

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

EquilibriumRehabilitationRandomized Controlled TrialPostural instabilitySensory-motor integration

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment

    At recruitment, after treatment (5 weeks) and in the follow-up (1 month)

Secondary Outcomes (1)

  • Clinical evaluation - Walking evaluation - Multiple Sclerosis Quality Of Life-54 (MSQOL-54) - Fatigue Severity Scale (FSS) - Postural Transfers

    At recruitment, after treatment (5 weeks) and in the follow-up (1 month)

Study Arms (2)

Sensory-motor Integration Training

EXPERIMENTAL
Procedure: Sensory-motor Integration Training

Conventional neurorehabilitation

ACTIVE COMPARATOR
Procedure: Conventional neurorehabilitation treatment

Interventions

Sensory-motor Integration TrainingPROCEDURE

Exercises will be divided into 3 levels. 1 Starting from the patient's most stable and comfortable standing position. 2 Patient will perform a single-step simulation, shifting his/her weight from one foot to the other in a frontal direction. 3 Patient will perform rapid movements, alternating feet in many directions, progressively increasing weight shifting and decreasing the support base amplitude. In the first five sessions exercises will be performed on a stable surface. During the remaining sessions patients will perform exercises on a compliant surface. During the two training periods the patient's visual condition will be progressively changed.

Sensory-motor Integration Training
Conventional neurorehabilitation treatmentPROCEDURE

The treatment will be consist in active joint mobilization, muscle stretching and strengthen and motor coordination exercises. In the first part of each session the active joint mobilization will be carried out while the patient was lying on a carpet in supine, prone. The training will continue with muscle stretching and strengthen exercises performed while patient will be in supine, prone (when possible) and standing. Motor coordination exercises will be carried out in supine position while sitting on a bench and in the standing position with a front support or with against a wall. The patient will be required to performed a total of 10 exercises with the following sequence: 6 exercises in supine position, 2 exercises in sitting position and 2 in standing position.

Conventional neurorehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \< 65 years
  • Expanded Disability Status Scale (EDSS) 2.0 \> score \< 6.0 (24)
  • Mini Mental State Evaluation (MMSE) score ≥ 24
  • Absence of cognitive impairment
  • Absence of heart problems
  • Self-reported sensation of postural instability
  • Ability to maintain standing position without aids for at least 1 minute
  • Ability to walk independently for at least 15 metres

You may not qualify if:

  • Disease recurrence that worsens significantly during the 3 months prior to recruitment
  • Pharmacological therapy not well defined
  • Presence of vestibular disorders and/or paroxysmal vertigo
  • Performance of any type of rehabilitation treatment in the month prior to recruitment
  • Presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

S.S.O. di Riabilitazione dell'Ospedale Policlinico

Verona, Verona, 37126, Italy

Location

Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

Verona, 37124, Italy

Location

Related Publications (4)

  • Smania N, Picelli A, Gandolfi M, Fiaschi A, Tinazzi M. Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Neurol Sci. 2008 Oct;29(5):313-9. doi: 10.1007/s10072-008-0988-0. Epub 2008 Oct 21.

    PMID: 18941933BACKGROUND

  • Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9.

    PMID: 18845654BACKGROUND

  • Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.

    PMID: 17875557BACKGROUND

  • Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial. Mult Scler. 2015 Oct;21(11):1453-62. doi: 10.1177/1352458514562438. Epub 2015 Jan 12.

    PMID: 25583852DERIVED

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Antonio Fiaschi, Professor

    Department of Neurological and Visual Sciences, University of Verona, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Smania Nicola

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

IT(2)