Unraveling Early Walking Dysfunction in Non-disabled MS People: Assessment and Potential Therapeutic Interventions
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Treadmill training, Instrumented assessment, Disease progression
Eligibility Criteria
Inclusion Criteria:
- Included will be patients residing in the centers' catchment areas
- Diagnosis of Multiple Sclerosis (Polman criteria)
- Stable disease course without worsening more than 1 Expanded Disability Status Scale (EDSS) point over the last 3 months
- EDSS < 2.5,
- Disease duration shorter than or equal to 5 years,
- Releasing a written informed consent.
Exclusion Criteria:
- Multiple Sclerosis relapse within the previous three months
- Cognitive impairment (MMSE score <27);
- Diagnosis of major depression (DSM-IV);
- Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
- Cardiovascular diseases;
- Unconfirmed or uncertain diagnosis of MS (Polman criteria)
- Other concomitant neurological diseases;
Sites / Locations
- Fondazione Don Gnocchi IrccsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Treadmill training Group
Arm Description
All subjects continue participating in their normal daily and physical activities.
16 sessions (2 sessions/week for 8 weeks) of treadmill training as recommended in a review on this subject (Langeskov-Christensen, 2015) aimed at the reduction/stabilization of gait and balance disturbances.
Outcomes
Primary Outcome Measures
Change in Six Minutes Walking Test
Tool used to assess walking endurance
Change in Instrumented variables
Gait asymmetry, Root mean squared of trunk Jerk and gait regularity on the vertical and medio-lateral plane estimated by autocorrelation coefficients (Moe-Nilssen, 2004) during the Six minutes walking test.
Secondary Outcome Measures
the Twelve-Item Walking Scale
Patient reported outcome about walking
the Twentyfive-foot walking test
Tool used to assess walking velocity
The Fatigue Severity Scale
Patient reported outcome about fatigue
the Nine hole peg test
Tool used to assess manual dexterity
Full Information
NCT ID
NCT03492450
First Posted
April 3, 2018
Last Updated
July 5, 2019
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT03492450
Brief Title
Unraveling Early Walking Dysfunction in Non-disabled MS People: Assessment and Potential Therapeutic Interventions
Official Title
Unraveling Early Walking Dysfunction in Non-disabled MS People: Clinical and Instrumental Assessment of Disease Progression and Potential Therapeutic Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to set up a pilot study to investigate the effects of treadmill training in preventing the onset and worsening of walking impairments, balance deficits and fatigue.
Detailed Description
As regards the of potential impact of exercises on functional decline at best of our knowledge no studies have been done on preventive interventions on walking, balance and fatigue disorders in early diagnosed PwMS. However, preliminary studies found that walking exercises can improve performances in PwMS with mild disability. van der Berg et al (van der Berg, 2006) investigated whether four weeks of aerobic treadmill training would improve mobility and fatigue in PwMS. They found that aerobic treadmill training is feasible and well tolerated and walking speed and endurance increased after training without changes in reported fatigue. In agreement with this study, Sabapathy et al (Sabapathy, 2011) reported improvements in mobility after endurance exercise training. Recent reviews (Dalgas, 2008 and Heine, 2015) and a recent paper by Sandroff et al (Sandroff, 2015) suggested that endurance training at low moderate intensity is well tolerated, has beneficial effects and reduces level of fatigue in MS patients having EDSS lower than 7.
Furthermore, the long-term effects of walking based aerobic endurance exercise on gait parameters were investigated by Wonnemberg et al (Wonnemberg, 2015). They found that step cadence decreased significantly and the step length increased significantly after 12 months suggesting that walking based aerobic endurance exercise may contribute to improved gait parameters in MS patients.
Walking exercises can be performed using treadmills. A Systematic review by Swinnen et al. (Swinnen, 2012) addresses the effect of different treadmill training (TT) modalities in PwMS. It showed that treadmill training improves walking skills and distance. In addition, Braendvik et al (Braendvik, 2015) revealed that TT was superior progressive strength training in improving walking in mild to moderate PwMS. Peruzzi et al. (Peruzzi, 2016) found similar results using Virtual Reality-based TT in PwMS with mild to moderate disability. After training, gait speed, stride length and the ability in negotiating obstacles were improved. Finally Gervasoni et al (Gervasoni, 2013) showed that 3-week of treadmill training reduced fatigue in PwMS.
The Hypothesis to be tested is that treadmill training can reduce subtle balance and gait impairments decreasing the impact of MS on the activities of daily living and, thereby, favorably impact on the disease progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Treadmill training, Instrumented assessment, Disease progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
All subjects continue participating in their normal daily and physical activities.
Arm Title
Treadmill training Group
Arm Type
Experimental
Arm Description
16 sessions (2 sessions/week for 8 weeks) of treadmill training as recommended in a review on this subject (Langeskov-Christensen, 2015) aimed at the reduction/stabilization of gait and balance disturbances.
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
Tailored treatment comprising of: 1) aerobic exercises with the aim of increasing fitness 2) task-oriented balance exercises on the treadmill to improve balance and 3) cognitive behavioral interventions to improve balance and gait during dual task activities.In accordance with the literature (Langeskov-Christensen, 2015, Latimer-Cheung, 2013) the treadmill training will be carried out without body weight support, but the participants will be allowed to use the handrails for balance support if needed. The training consists of three different walking sessions, each lasting for 10 minutes: 1) preferred walking speed at an increased slope; 2) walking doing dynamic balance exercises (for example walking with feet in tandem) 3) fast gait speed defined as a 10% increase in walking speed relative to preferred speed with dual task exercises. During the 8-week intervention, walking speed in session 3 will be gradually increased with 10% to 40% of preferred speed.
Primary Outcome Measure Information:
Title
Change in Six Minutes Walking Test
Description
Tool used to assess walking endurance
Time Frame
Change from Baseline 6 minutes walking test scores at 8 weeks
Title
Change in Instrumented variables
Description
Gait asymmetry, Root mean squared of trunk Jerk and gait regularity on the vertical and medio-lateral plane estimated by autocorrelation coefficients (Moe-Nilssen, 2004) during the Six minutes walking test.
Time Frame
Change from Baseline scores at 8 weeks
Secondary Outcome Measure Information:
Title
the Twelve-Item Walking Scale
Description
Patient reported outcome about walking
Time Frame
Change from Baseline Twelve-Item Walking Scale scores at 8 weeks
Title
the Twentyfive-foot walking test
Description
Tool used to assess walking velocity
Time Frame
Change from Baseline Twentyfive-foot walking test scores at 8 weeks
Title
The Fatigue Severity Scale
Description
Patient reported outcome about fatigue
Time Frame
Change from Baseline Fatigue Severity Scale scores at 8 weeks
Title
the Nine hole peg test
Description
Tool used to assess manual dexterity
Time Frame
Change from Baseline Nine Hole Peg test scores at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Included will be patients residing in the centers' catchment areas
Diagnosis of Multiple Sclerosis (Polman criteria)
Stable disease course without worsening more than 1 Expanded Disability Status Scale (EDSS) point over the last 3 months
EDSS < 2.5,
Disease duration shorter than or equal to 5 years,
Releasing a written informed consent.
Exclusion Criteria:
Multiple Sclerosis relapse within the previous three months
Cognitive impairment (MMSE score <27);
Diagnosis of major depression (DSM-IV);
Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
Cardiovascular diseases;
Unconfirmed or uncertain diagnosis of MS (Polman criteria)
Other concomitant neurological diseases;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Cattaneo, PhD
Phone
+390240308
Ext
814
Email
dcattaneo@dongnocchi.it
Facility Information:
Facility Name
Fondazione Don Gnocchi Irccs
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DAVIDE CATTANEO, PhD
12. IPD Sharing Statement
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Unraveling Early Walking Dysfunction in Non-disabled MS People: Assessment and Potential Therapeutic Interventions
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