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Trekking Poles to Aid Multiple Sclerosis Gait Impairment (TRAMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No device
Single-point cane (SPC)
Four-point cane (FPC)
Trekking pole (TP).
Sponsored by
Rowan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Walking, Gait

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rowan University School of Osteopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

No Device

Single Point Cane

Four-Point Cane

Trekking Pole

Arm Description

Assistive device conditions

Assistive device condition

Assistive device condition

Assistive device condition

Outcomes

Primary Outcome Measures

Composite measures of walking
Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)

Secondary Outcome Measures

Full Information

First Posted
August 20, 2014
Last Updated
October 24, 2019
Sponsor
Rowan University
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1. Study Identification

Unique Protocol Identification Number
NCT02227524
Brief Title
Trekking Poles to Aid Multiple Sclerosis Gait Impairment
Acronym
TRAMS
Official Title
Trekking Poles to Aid Multiple Sclerosis Gait Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rowan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Walking, Gait

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Device
Arm Type
Experimental
Arm Description
Assistive device conditions
Arm Title
Single Point Cane
Arm Type
Experimental
Arm Description
Assistive device condition
Arm Title
Four-Point Cane
Arm Type
Experimental
Arm Description
Assistive device condition
Arm Title
Trekking Pole
Arm Type
Experimental
Arm Description
Assistive device condition
Intervention Type
Other
Intervention Name(s)
No device
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Single-point cane (SPC)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Four-point cane (FPC)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Trekking pole (TP).
Intervention Description
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 Measure Information:
Title
Composite measures of walking
Description
Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Barone, DO
Organizational Affiliation
Rowan University School of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rowan University School of Osteopathic Medicine
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Trekking Poles to Aid Multiple Sclerosis Gait Impairment

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