Trekking Poles to Aid Multiple Sclerosis Gait Impairment

NCT ID: NCT02227524

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-03-07

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No Device

Assistive device conditions

Group Type EXPERIMENTAL

No device

Intervention Type OTHER

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).

Single-point cane (SPC)

Intervention Type 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).

Four-point cane (FPC)

Intervention Type 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).

Trekking pole (TP).

Intervention Type 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).

Single Point Cane

Assistive device condition

Group Type EXPERIMENTAL

No device

Intervention Type OTHER

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).

Single-point cane (SPC)

Intervention Type 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).

Four-point cane (FPC)

Intervention Type 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).

Trekking pole (TP).

Intervention Type 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).

Four-Point Cane

Assistive device condition

Group Type EXPERIMENTAL

No device

Intervention Type OTHER

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).

Single-point cane (SPC)

Intervention Type 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).

Four-point cane (FPC)

Intervention Type 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).

Trekking pole (TP).

Intervention Type 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).

Trekking Pole

Assistive device condition

Group Type EXPERIMENTAL

No device

Intervention Type OTHER

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).

Single-point cane (SPC)

Intervention Type 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).

Four-point cane (FPC)

Intervention Type 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).

Trekking pole (TP).

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

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).

Intervention Type 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).

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rowan University

OTHER

Sponsor Role lead

Responsible Party

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Eric Gregory

Director of Research Compliance

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald Barone, DO

Role: PRINCIPAL_INVESTIGATOR

Rowan University School of Osteopathic Medicine

Locations

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Rowan University School of Osteopathic Medicine

Stratford, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Pro201300052

Identifier Type: -

Identifier Source: org_study_id

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