Trekking Poles to Aid Multiple Sclerosis Gait Impairment

Multiple Sclerosis Clinical Trial

— TRAMS  

Official title:

Trekking Poles to Aid Multiple Sclerosis Gait Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227524
• Other study ID #: Pro201300052
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: March 7, 2019

Study information

• Verified date: April 2024
• Source: Rowan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Rowan University School of Osteopathic Medicine	Stratford	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rowan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measures of walking	Temporal and spatial parameters of gait/walking (measured with the GAITRite portable walkway system)	1 year