Relapsing-Remitting Multiple SclerosisNCT01564511
Effects of Electromechanical Gait Trainer in Patients With Multiple Sclerosis
A study testing Gait trainer treatment and Conventional treatment in people with Relapsing-Remitting Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
Trial summary
Multiple Sclerosis is a very disabling disorder in young adult patients leading to an important limitation in daily life activities and social participation. Among of the different causes of disability in MS patients gait impairments, fatigue and balance disorders can be considered as the main concerns. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Gait trainer treatment and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Dec 2012
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 30 and 60 years
- Expanded Disability Status Scale (EDSS) score 2.0≥ x ≤ 4.0
- Mini Mental State Evaluation (MMSE) score ≥ 24
- absence of heart problems
- ability to maintain standing position without aids for at least 1 minute
- ability to walk independently for at least 15 metres
- absence of concurrent neurological or orthopaedic diseases that interfere with deambulation.
Who cannot join
- disease recurrence that worsens significantly during the 3 months prior to recruitment
- pharmacological therapy not well defined
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.S.O. di Riabilitazione dell'Ospedale Policlinico
Verona, Verona, 37124
About this study
Official title: Effects of Electromechanical Gait Trainer on Endurance, Fatigue and Daily Life Autonomy in Patients With Multiple Sclerosis: a Randomized Control Trial
Multiple Sclerosis is a very disabling disorder in young adult patients leading to an important limitation in daily life activities and social participation. Among of the different causes of disability in MS patients gait impairments, fatigue and balance disorders can be considered as the main concerns. Thus, gait restoration in patients with MS is the one of the primary objective of rehabilitation and often influences whether a patient can return home or to work. Even if potentially innovative treatments like treadmill training have been proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been extensively studied in patients with MS.
Read the detailed description
Background Multiple sclerosis (MS) is the most common chronic disabling disease of the central nervous system in young adults. Gait disorders represent one of the greatest causes of disability in patients with MS. Thus, gait restoration in patients with MS is the one of the primary objective of rehabilitation and often influences whether a patient can return home or to work.
Despite significant progress in the development of disease-modifying drugs, pharmacologic therapy alone does not warrant optimal care in MS. Exercise has been recognized as a feasible form of self-management for persons with the disease. Regular exercise can improve daily activity, cardiovascular fitness, muscle strength, health perception, and reduce fatigue in patients with MS.
To restore gait, modern concepts of rehabilitation support a repetitive task-specific approach. In recent years it has also been shown that higher intensities of walking practice (resulting in more repetitions trained) result in better outcomes for patients after stroke. Recently, the introduction of robotic devices for gait rehabilitation have showed to be a feasible approach in order to improve gait ability in patients with stroke and spinal cord lesions. These devices allow to train patients under a graduated body weight support condition and to guide the patient's steps reproducing a physiologic gait pattern for as long as the clinical conditions allow. This activity can be executed requiring only supervision by a physiotherapist and in absolutely safety condition for the patient.
Repetitive locomotor training is an innovative approach in gait disturbances in patients with multiple sclerosis. Only scant data on this issue is available and all these studies have been performed by means of conventional physiotherapy or treadmill training approaches. Nowadays the effectiveness of robotic devices for gait rehabilitation has not yet been evaluated in patients with multiple sclerosis.
Aim of the study The aim of the study is to evaluate the effect of a repetitive locomotor training by electromechanical gait trainer on gait endurance, fatigue and activities daily life in patients with MS.
Study Design Randomised controlled, blinded clinical trial. Materials and methods Fifty patients with definite diagnosis of MS according to McDonald criteria, and with EDSS score equal to or below 7 will be enrolled in the study. Patients with disease recurrence that worsens significantly during the 8 weeks before recruitment will be excluded. At the moment of recruitment (before treatment), at the end of treatment (6 weeks) and one month after the end of the treatment (FU) each patient will be tested with the following clinical and instrumental procedures. Clinical assessment procedures: 6-minute Walking Test, 10-meter Walking Test, Fatigue Severity Scale, Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression, Falls Efficacy Scale. Instrumental assessment procedures: GAITRite® System, Stabilometric Assessment and measure of energy cost by COSMED K4b2.
As primary outcome measure will be considered the 6-minute Walking Distance Test. As secondary outcomes measures will be considered the 10-meter Walking Test, Fatigue Severity Scale and the Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression, Falls Efficacy Scale, Spatio-temporal parameter with GAITRite® System, Stabilometric Assessment and measure of energy cost by COSMED K4b2. The allocation in the two groups will be done with simple randomisation.
Patients will be randomized into two groups. The first group (experimental group) will be subjected to 12 treatment session (2 sessions/week) on Gait Trainer machine. The second group (control group) will undergo to a conventional treatment with the same duration and frequency of the experimental group. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed. Data will be analyzed using SPSS software (ver 11.0; SPSS Inc., Chicago, IL, USA). Expected results: we could hypothesize that the training performed by the experimental group could improve gait endurance and daily life disability in patients with MS.
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Being tested
- Gait trainer treatment, Conventional treatment
- Keywords
- Multiple Sclerosis, Robotic Rahabilitation, Fatigue, Gait disorder
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Fatigue, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainer treatmentDevice
Patients will be subjected to 40 minutes of repetitive locomotor therapy on the Gait Trainer (GTI) (Reha-Stim, Berlin, Germany), followed by 10 minutes of passive joint mobilization and stretching exercises. The first 40 min session will be divided as follow: 15 min gait training; 5 minutes at rest; 15 minutes gait training; 5 minutes at rest. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion.
Conventional treatmentOther
The control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Gait trainer treatment | Experimental | Roboti gait training by mean of Gangtrainer I Receives: Device: Gait trainer treatment |
| Conventional group | Sham comparator | Convetional physical gait training Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute Walking Test
This is a validated test for the clinical evaluation of walking endurance using in patient with MS. It involves respiratory, cardiovascular, skeletal, nervous and muscular system competences/skills (32). The patient will be asked to walk at her/his self-selected walking speed in the gym along during the instrumental test.
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.
Secondary outcomes (6)
10-meter Walking Test
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Falls efficacy scale score
This is a scale used to assess fatigue in MS and other chronic diseases. It consists of a self-report questionnaire composed of nine items. Each item is scored on a seven-point scale ranging from 1 (absence of fatigue) to 7 (high level of fatigue). The score ranges from 9 to 63. Total score from each questionnaire will be reported in excel sheet at each evaluation session.
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Spatio-temporal gait analysis
Spatio-temporal gait analysis will be evaluated by using a computerized system called GAITRite system (Gold, version 3.2 b - CIR Systems, Inc, Havertown, PA). Patients will ask to ambulate along the 7.66m electronic walkway at their fastest speed. The following gait parameters will be considered: gait speed (cm/sec), cadence (step/min), stride length (cm), step length (cm), heel to heel base support (cm), swing of cycle (%), stance of cycle (%), single support of cycle (%) and double support of cycle (%). Each parameters will be reported in excel sheet at each evaluation session.
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Static balance assessment
The static balance assessment will be carried out with a monoaxial platform (Technoboby©) an electronic system used for the evaluation of the instant position of the centre of pressure (CoP), the length of CoP trajectory (LCop) and the distribution of sway area (DSA). The position of the feet on the platform is standardized using a V-shaped frame. The parameters above-mentioned will be calculated by computing data obtained under different visual conditions (eyes-open and eyes-closed) during a 30-sec time interval.
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Measure of energy cost
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Hamilton Rating Scale for Depression
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
- Investigators
- Antonio Fiaschi, Professor, Study chair, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564511
- Sponsor's protocol ID
- GT&SM-01
- Status last verified
- Sep 2016
- First submitted
- 14 Mar 2012
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.
PubMed 18971381Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
PubMed 17213237Benedetti MG, Gasparroni V, Stecchi S, Zilioli R, Straudi S, Piperno R. Treadmill exercise in early mutiple sclerosis: a case series study. Eur J Phys Rehabil Med. 2009 Mar;45(1):53-9.
PubMed 19156023
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electromechanical Gait Trainer on Endurance, Fatigue and Daily Life Autonomy in Patients With Multiple Sclerosis: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01564511
- Acronym / sponsor ID
- GT&SM-01
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Robotic Rahabilitation, Fatigue, Gait disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Mar 2012 (estimated)
- 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.
Multiple Sclerosis is a very disabling disorder in young adult patients leading to an important limitation in daily life activities and social participation. Among of the different causes of disability in MS patients gait impairments, fatigue and balance disorders can be considered as the main concerns. Thus, gait restoration in patients with MS is the one of the primary objective of rehabilitation and often influences whether a patient can return home or to work. Even if potentially innovative treatments like treadmill training have been proposed, nowadays the role of robotic assisted locomotion rehabilitation has not been extensively studied in patients with MS.
Detailed description
Background Multiple sclerosis (MS) is the most common chronic disabling disease of the central nervous system in young adults. Gait disorders represent one of the greatest causes of disability in patients with MS. Thus, gait restoration in patients with MS is the one of the primary objective of rehabilitation and often influences whether a patient can return home or to work.
Despite significant progress in the development of disease-modifying drugs, pharmacologic therapy alone does not warrant optimal care in MS. Exercise has been recognized as a feasible form of self-management for persons with the disease. Regular exercise can improve daily activity, cardiovascular fitness, muscle strength, health perception, and reduce fatigue in patients with MS.
To restore gait, modern concepts of rehabilitation support a repetitive task-specific approach. In recent years it has also been shown that higher intensities of walking practice (resulting in more repetitions trained) result in better outcomes for patients after stroke. Recently, the introduction of robotic devices for gait rehabilitation have showed to be a feasible approach in order to improve gait ability in patients with stroke and spinal cord lesions. These devices allow to train patients under a graduated body weight support condition and to guide the patient's steps reproducing a physiologic gait pattern for as long as the clinical conditions allow. This activity can be executed requiring only supervision by a physiotherapist and in absolutely safety condition for the patient.
Repetitive locomotor training is an innovative approach in gait disturbances in patients with multiple sclerosis. Only scant data on this issue is available and all these studies have been performed by means of conventional physiotherapy or treadmill training approaches. Nowadays the effectiveness of robotic devices for gait rehabilitation has not yet been evaluated in patients with multiple sclerosis.
Aim of the study The aim of the study is to evaluate the effect of a repetitive locomotor training by electromechanical gait trainer on gait endurance, fatigue and activities daily life in patients with MS.
Study Design Randomised controlled, blinded clinical trial. Materials and methods Fifty patients with definite diagnosis of MS according to McDonald criteria, and with EDSS score equal to or below 7 will be enrolled in the study. Patients with disease recurrence that worsens significantly during the 8 weeks before recruitment will be excluded. At the moment of recruitment (before treatment), at the end of treatment (6 weeks) and one month after the end of the treatment (FU) each patient will be tested with the following clinical and instrumental procedures. Clinical assessment procedures: 6-minute Walking Test, 10-meter Walking Test, Fatigue Severity Scale, Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression, Falls Efficacy Scale. Instrumental assessment procedures: GAITRite® System, Stabilometric Assessment and measure of energy cost by COSMED K4b2.
As primary outcome measure will be considered the 6-minute Walking Distance Test. As secondary outcomes measures will be considered the 10-meter Walking Test, Fatigue Severity Scale and the Multiple Sclerosis Quality Of Life-54, Hamilton Rating Scale for Depression, Falls Efficacy Scale, Spatio-temporal parameter with GAITRite® System, Stabilometric Assessment and measure of energy cost by COSMED K4b2. The allocation in the two groups will be done with simple randomisation.
Patients will be randomized into two groups. The first group (experimental group) will be subjected to 12 treatment session (2 sessions/week) on Gait Trainer machine. The second group (control group) will undergo to a conventional treatment with the same duration and frequency of the experimental group. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed. Data will be analyzed using SPSS software (ver 11.0; SPSS Inc., Chicago, IL, USA). Expected results: we could hypothesize that the training performed by the experimental group could improve gait endurance and daily life disability in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait trainer treatment | Experimental | Device: Gait trainer treatmentRoboti gait training by mean of Gangtrainer I |
| Conventional group | Sham comparator | Other: Conventional treatmentConvetional physical gait training |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age between 30 and 60 years
- Expanded Disability Status Scale (EDSS) score 2.0≥ x ≤ 4.0
- Mini Mental State Evaluation (MMSE) score ≥ 24
- absence of heart problems
- ability to maintain standing position without aids for at least 1 minute
Key exclusion criteria (4 listed)
- disease recurrence that worsens significantly during the 3 months prior to recruitment
- pharmacological therapy not well defined
- 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
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 |
|---|---|---|
| Gait trainer treatmentPatients will be subjected to 40 minutes of repetitive locomotor therapy on the Gait Trainer (GTI) (Reha-Stim, Berlin, Germany), followed by 10 minutes of passive joint mobilization and stretching exercises. The first 40 min session will be divided as follow: 15 min gait training; 5 minutes at rest; 15 minutes gait training; 5 minutes at rest. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion. | Device | Gait trainer treatment |
| Conventional treatmentThe control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes. | Other | Conventional group |
Primary outcome
6-minute Walking Test
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.
This is a validated test for the clinical evaluation of walking endurance using in patient with MS. It involves respiratory, cardiovascular, skeletal, nervous and muscular system competences/skills (32). The patient will be asked to walk at her/his self-selected walking speed in the gym along during the instrumental test.
6 secondary outcomes
10-meter Walking Test
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Falls efficacy scale score
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Spatio-temporal gait analysis
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Static balance assessment
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Measure of energy cost
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Hamilton Rating Scale for Depression
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Background: PubMed 18971381Lo AC, Triche EW. Improving gait in multiple sclerosis using robot-assisted, body weight supported treadmill training. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):661-71. doi: 10.1177/1545968308318473.
- Background: PubMed 17213237Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
- Background: PubMed 19156023Benedetti MG, Gasparroni V, Stecchi S, Zilioli R, Straudi S, Piperno R. Treadmill exercise in early mutiple sclerosis: a case series study. Eur J Phys Rehabil Med. 2009 Mar;45(1):53-9.
Related trials for Relapsing-Remitting Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
Antonio Fiaschi, Professor study chair
Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait trainer treatment and Conventional treatment in people with Relapsing-Remitting Multiple Sclerosis, run by Universita di Verona 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 12 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute Walking Test (time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01564511, which also lists 3 linked publications.
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 12 Sep 2016.