Trekking Poles to Aid Multiple Sclerosis Gait Impairment (TRAMS)
April 9, 2024 updated by: Eric Gregory, Rowan University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Stratford, New Jersey, United States, 08084
- Rowan University School of Osteopathic Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: No Device
Assistive device conditions
|
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).
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).
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).
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).
|
|
Experimental: Single Point Cane
Assistive device condition
|
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).
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).
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).
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).
|
|
Experimental: Four-Point Cane
Assistive device condition
|
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).
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).
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).
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).
|
|
Experimental: Trekking Pole
Assistive device condition
|
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).
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).
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).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite measures of walking
Time Frame: 1 year
|
Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Donald Barone, DO, Rowan University School of Osteopathic Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
March 7, 2019
Study Completion (Actual)
March 7, 2019
Study Registration Dates
First Submitted
August 20, 2014
First Submitted That Met QC Criteria
August 27, 2014
First Posted (Estimated)
August 28, 2014
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro201300052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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