Multiple SclerosisNCT03492450
Unraveling Early Walking Dysfunction in Non-disabled MS People: Assessment and Potential Therapeutic Interventions
A study testing Treadmill training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Gnocchi Irccs
Milan
DAVIDE CATTANEO, PhD
About this study
Official title: Unraveling Early Walking Dysfunction in Non-disabled MS People: Clinical and Instrumental Assessment of Disease Progression and Potential Therapeutic Interventions
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Treadmill training
- Keywords
- Treadmill training, Instrumented assessment, Disease progression
- Medical subject headings
- Multiple Sclerosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | All subjects continue participating in their normal daily and physical activities. |
| Treadmill training Group | Experimental | 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. Receives: Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Six Minutes Walking Test
Tool used to assess walking endurance
Measured: Change from Baseline 6 minutes walking test scores at 8 weeks
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.
Measured: Change from Baseline scores at 8 weeks
Secondary outcomes (4)
the Twelve-Item Walking Scale
Patient reported outcome about walking
Measured: Change from Baseline Twelve-Item Walking Scale scores at 8 weeks
the Twentyfive-foot walking test
Tool used to assess walking velocity
Measured: Change from Baseline Twentyfive-foot walking test scores at 8 weeks
The Fatigue Severity Scale
Patient reported outcome about fatigue
Measured: Change from Baseline Fatigue Severity Scale scores at 8 weeks
the Nine hole peg test
Tool used to assess manual dexterity
Measured: Change from Baseline Nine Hole Peg test scores at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start12 May 2018
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492450
- Sponsor's protocol ID
- FISM Call 2016 cod. 2016/R/1
- Status last verified
- Oct 2018
- First submitted
- 3 Apr 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling Early Walking Dysfunction in Non-disabled MS People: Clinical and Instrumental Assessment of Disease Progression and Potential Therapeutic Interventions
- ClinicalTrials.gov ID
- NCT03492450
- Acronym / sponsor ID
- FISM Call 2016 cod. 2016/R/1
- Conditions
- Multiple Sclerosis
- Keywords
- Treadmill training, Instrumented assessment, Disease progression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 12 May 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –All subjects continue participating in their normal daily and physical activities. |
| Treadmill training Group | Experimental | Other: Treadmill training16 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill trainingTailored 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. | Other | Treadmill training Group |
Primary outcome
Change in Six Minutes Walking Test
Time frame: Change from Baseline 6 minutes walking test scores at 8 weeks
Tool used to assess walking endurance
Change in Instrumented variables
Time frame: Change from Baseline scores at 8 weeks
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.
4 secondary outcomes
the Twelve-Item Walking Scale
Time frame: Change from Baseline Twelve-Item Walking Scale scores at 8 weeks
the Twentyfive-foot walking test
Time frame: Change from Baseline Twentyfive-foot walking test scores at 8 weeks
The Fatigue Severity Scale
Time frame: Change from Baseline Fatigue Severity Scale scores at 8 weeks
the Nine hole peg test
Time frame: Change from Baseline Nine Hole Peg test scores at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Cattaneo, PhD (+390240308 ext. 814, dcattaneo@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Six Minutes Walking Test (time frame: Change from Baseline 6 minutes walking test scores at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.