NCT03271125

Brief Summary

The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative multimodal training protocol carried out on treadmill on walking efficacy, mobility, balance, executive function, fatigue and health-related quality of life in a sample of persons with moderate to severe MS deficit of mobility compared to a control group that received a strengthening program of similar intensity.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

August 31, 2017

Last Update Submit

August 31, 2017

Conditions

RehabilitationMultiple Sclerosis

Keywords

InterventionMultiple sclerosisTreadmillMobility

Outcome Measures

Primary Outcomes (2)

  • Two minute walking test

    The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.

    Two minutes

  • Timed up and go test

    The Timed Up \& Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.

    1 minute

Secondary Outcomes (5)

  • The Frontal Assessment Battery

    10 minutes

  • Ten meter walking test

    2 minutes

  • The Berg Balance Scale

    15 minutes

  • Dynamic Gait Index

    15 minutes

  • The Short Form-12 questionnaire (SF-12)

    10 minutes

Study Arms (2)

Treadmill group

EXPERIMENTAL

Participants in the experimental group received supervised treadmill training

Behavioral: Treadmill

Resistance group

ACTIVE COMPARATOR

Participants in the control group were treated with Resistance exercises.

Behavioral: Resistance

Interventions

TreadmillBEHAVIORAL

Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.

Treadmill group
ResistanceBEHAVIORAL

Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise

Resistance group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of multiple sclerosis according to McDonald's criteria (Polman et al. Ann Neurology 2011)
  • EDSS score \<= 7
  • Free from relapses and steroid treatment for at least 1 month)
  • Able to stand 30 seconds,
  • Able to walk at least 10 meters independently or with a cane
  • Able to understand and follow instructions
  • Stable neurological conditions and willingness to participate in the study.

You may not qualify if:

  • Cardiac pacemaker
  • Any pre-existing conditions that affected walking function
  • diagnosis of depression or psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Don Carlo Gnocchi IRCCS

Milan, MI, 20148, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

January 8, 2013

Primary Completion

May 19, 2015

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

IT(1)