Multiple SclerosisTRAMSNCT02227524
Trekking Poles to Aid Multiple Sclerosis Gait Impairment
A study testing No device, Single-point cane (SPC) and Four-point cane (FPC) in people with Multiple Sclerosis, run by Rowan University at 1 site in United States.
Trial summary
In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- No device, Single-point cane (SPC) and Four-point cane (FPC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 7 Mar 2019
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be 18-64 years old with a confirmed diagnosis of MS
- Have perceived walking difficulty
- Have an EDSS score of < 6, calculated by the physician
- Ability to understand study procedures and to comply with them for the entire length of the study
Who cannot join
- Have had a MS exacerbation in the prior 8 weeks
- Have other serious medical conditions that would impair their ability to participate in gait performance testing (i.e. severe rheumatoid arthritis or osteoarthritis)
- If the physician deems a participant unsafe to go home with devices
- Cannot communicate in English
- Possess greater than a mild decrease in mentation (i.e. a score of >2 on the Mental Functions item of the FSS)
- Inability or unwillingness of individual to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Rowan University School of Osteopathic Medicine
Stratford, New Jersey, 08084
About this study
In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used.
Read the detailed description
In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used. In addition, the investigators will examine the psychosocial impact and amount of fatigue induced by each assistive device. Data collection will consist of a series of assessments via survey and physical performance. The analyses will consist of appropriate comparisons of means to determine if the use of different assistive devices alters any of the outcomes.
- Conditions
- Multiple Sclerosis
- Being tested
- No device, Single-point cane (SPC), Four-point cane (FPC), Trekking pole (TP).
- Keywords
- Multiple Sclerosis, Walking, Gait
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No deviceOther
Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
Single-point cane (SPC)Device
Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
Four-point cane (FPC)Device
Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
Trekking pole (TP).Device
Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
| Study group | Role | What they receive |
|---|---|---|
| No Device | Experimental | Assistive device conditions Receives: Other: No device; Device: Single-point cane (SPC); Device: Four-point cane (FPC); Device: Trekking pole (TP). |
| Single Point Cane | Experimental | Assistive device condition Receives: Other: No device; Device: Single-point cane (SPC); Device: Four-point cane (FPC); Device: Trekking pole (TP). |
| Four-Point Cane | Experimental | Assistive device condition Receives: Other: No device; Device: Single-point cane (SPC); Device: Four-point cane (FPC); Device: Trekking pole (TP). |
| Trekking Pole | Experimental | Assistive device condition Receives: Other: No device; Device: Single-point cane (SPC); Device: Four-point cane (FPC); Device: Trekking pole (TP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measures of walking
Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startApr 2014
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Gregory, Rowan University
- Investigators
- Donald Barone, DO, Principal investigator, Rowan University School of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227524
- Sponsor's protocol ID
- Pro201300052
- Acronym
- TRAMS
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2014
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trekking Poles to Aid Multiple Sclerosis Gait Impairment
- ClinicalTrials.gov ID
- NCT02227524
- Acronym / sponsor ID
- TRAMS / Pro201300052
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Walking, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 28 Aug 2014 (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.
In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used.
Detailed description
In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used. In addition, the investigators will examine the psychosocial impact and amount of fatigue induced by each assistive device. Data collection will consist of a series of assessments via survey and physical performance. The analyses will consist of appropriate comparisons of means to determine if the use of different assistive devices alters any of the outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Device | Experimental | Other: No device, Device: Single-point cane (SPC), Device: Four-point cane (FPC), Device: Trekking pole (TP).Assistive device conditions |
| Single Point Cane | Experimental | Other: No device, Device: Single-point cane (SPC), Device: Four-point cane (FPC), Device: Trekking pole (TP).Assistive device condition |
| Four-Point Cane | Experimental | Other: No device, Device: Single-point cane (SPC), Device: Four-point cane (FPC), Device: Trekking pole (TP).Assistive device condition |
| Trekking Pole | Experimental | Other: No device, Device: Single-point cane (SPC), Device: Four-point cane (FPC), Device: Trekking pole (TP).Assistive device condition |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be 18-64 years old with a confirmed diagnosis of MS
- Have perceived walking difficulty
- Have an EDSS score of < 6, calculated by the physician
- Ability to understand study procedures and to comply with them for the entire length of the study
Key exclusion criteria (6 listed)
- Have had a MS exacerbation in the prior 8 weeks
- Have other serious medical conditions that would impair their ability to participate in gait performance testing (i.e. severe rheumatoid arthritis or osteoarthritis)
- If the physician deems a participant unsafe to go home with devices
- Cannot communicate in English
- Possess greater than a mild decrease in mentation (i.e. a score of >2 on the Mental Functions item of the FSS)
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 |
|---|---|---|
| No deviceCompare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP). | Other | Four-Point Cane, No Device, Single Point Cane, Trekking Pole |
| Single-point cane (SPC)Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP). | Device | Four-Point Cane, No Device, Single Point Cane, Trekking Pole |
| Four-point cane (FPC)Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP). | Device | Four-Point Cane, No Device, Single Point Cane, Trekking Pole |
| Trekking pole (TP).Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP). | Device | Four-Point Cane, No Device, Single Point Cane, Trekking Pole |
Primary outcome
Composite measures of walking
Time frame: 1 year
Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)
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 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Donald Barone, DO principal investigator
Rowan University School of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No device, Single-point cane (SPC) and Four-point cane (FPC) in people with Multiple Sclerosis, run by Rowan University at 1 site in United States.
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 4 inclusion and 6 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 11 Apr 2024. 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 United States. 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?
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?
Composite measures of walking (time frame: 1 year). 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 11 Apr 2024.