NCT02421744

Brief Summary

Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment. Our secondary hypothesis is that there could be retention of clinical gains in subjects that underwent TOCT plus structured 3 months home exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable multiple-sclerosis

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 29, 2018

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

January 19, 2015

Last Update Submit

November 28, 2018

Conditions

Multiple Sclerosis

Keywords

rehabilitationMultiple Sclerosismobilitygaittask-oriented training

Outcome Measures

Primary Outcomes (1)

  • Six-Minute Walking Test

    The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes, with the possibility to slow down and rest if necessary.

    Weeks: 0,2,14, 26

Secondary Outcomes (13)

  • Timed 25-Foot walk (25FWT)

    weeks: 0,2,14, 26

  • Time Up and Go Test

    weeks: 0,2,14, 26

  • Dynamic Gait Index (DGI)

    weeks: 0,2,14, 26

  • Modified fatigue impact scale (MFIS)

    weeks: 0,2,14, 26

  • Multiple Sclerosis Walking Scale - 12 (MSWS-12)

    weeks: 0,2,14, 26

  • +8 more secondary outcomes

Study Arms (2)

Task Oriented Circuit Training

EXPERIMENTAL

TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months.

Behavioral: Task Oriented Circuit Training

Delayed Onset TOCT

ACTIVE COMPARATOR

The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months.

Behavioral: Delayed Onset TOCT

Interventions

Task Oriented Circuit TrainingBEHAVIORAL

TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months.

Task Oriented Circuit Training
Delayed Onset TOCTBEHAVIORAL

The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months.

Delayed Onset TOCT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males and females,
  • community dwelling,
  • age \>18 and \<75
  • diagnosis of multiple sclerosis in a stable phase, with relapses \> 3 months prior to study enrollment
  • moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5
  • MMSE \>24

You may not qualify if:

  • neurologic conditions in addition to multiple sclerosis that may affect motor function
  • medical conditions likely to interfere with the ability to safely complete the study
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ferrara University Hospital

Ferrara, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sofia Straudi, MD

    Ferrara Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2015

First Posted

April 21, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 29, 2018

Record last verified: 2017-05

Locations

IT(2)