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Trekking Poles to Aid Multiple Sclerosis Gait Impairment (TRAMS)

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ClinicalTrials.gov Identifier: NCT02227524
Recruitment Status : Unknown
Verified July 2016 by Donald Barone, Rowan University.
Recruitment status was:  Recruiting
First Posted : August 28, 2014
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Donald Barone, Rowan University

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: No device Device: Single-point cane (SPC) Device: Four-point cane (FPC) Device: Trekking pole (TP). Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Official Title: Trekking Poles to Aid Multiple Sclerosis Gait Impairment
Study Start Date : April 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: No Device
Assistive device conditions
Other: No 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).

Device: 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 (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: 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
Other: No 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).

Device: 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 (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: 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
Other: No 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).

Device: 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 (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: 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
Other: No 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).

Device: 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 (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: 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).




Primary Outcome Measures :
  1. Composite measures of walking [ Time Frame: 1 year ]
    Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227524


Locations
United States, New Jersey
Rowan University School of Osteopathic Medicine Recruiting
Stratford, New Jersey, United States, 08084
Contact: Jillian Stanley, BA    856-566-2305    stanle27@rowan.edu   
Contact: Donald Barone, DO    856-566-6406    dbarone1@rowan.edu   
Principal Investigator: Donald Barone, DO         
Sub-Investigator: Evan Cohen, PhD         
Sponsors and Collaborators
Rowan University
Investigators
Principal Investigator: Donald Barone, DO Rowan University School of Osteopathic Medicine

Responsible Party: Donald Barone, Chief, Division of Neurology, Rowan University
ClinicalTrials.gov Identifier: NCT02227524     History of Changes
Other Study ID Numbers: Pro201300052
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Donald Barone, Rowan University:
Multiple Sclerosis
Walking
Gait

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases