Trekking Poles to Aid Multiple Sclerosis Gait Impairment (TRAMS)

Rowan University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Four-point cane (FPC); Device: Trekking pole (TP).; Other: No device; Device: Single-point cane (SPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02227524

Pro201300052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

No Device

Experimental group

Description:

Assistive device conditions

Treatment:

Device: Single-point cane (SPC)

Device: Four-point cane (FPC)

Device: Trekking pole (TP).

Other: No device

Single Point Cane

Experimental group

Description:

Assistive device condition

Treatment:

Device: Single-point cane (SPC)

Device: Four-point cane (FPC)

Device: Trekking pole (TP).

Other: No device

Four-Point Cane

Experimental group

Description:

Assistive device condition

Treatment:

Device: Single-point cane (SPC)

Device: Four-point cane (FPC)

Device: Trekking pole (TP).

Other: No device

Trekking Pole

Experimental group

Description:

Assistive device condition

Treatment:

Device: Single-point cane (SPC)

Device: Four-point cane (FPC)

Device: Trekking pole (TP).

Other: No device