NCT02227524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2019

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

4.9 years

First QC Date

August 20, 2014

Last Update Submit

April 9, 2024

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisWalkingGait

Outcome Measures

Primary Outcomes (1)

  • Composite measures of walking

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

    1 year

Study Arms (4)

No Device

EXPERIMENTAL

Assistive device conditions

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

Single Point Cane

EXPERIMENTAL

Assistive device condition

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

Four-Point Cane

EXPERIMENTAL

Assistive device condition

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

Trekking Pole

EXPERIMENTAL

Assistive device condition

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

Interventions

No deviceOTHER

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 CaneNo DeviceSingle Point CaneTrekking Pole
Single-point cane (SPC)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 CaneNo DeviceSingle Point CaneTrekking Pole
Four-point cane (FPC)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 CaneNo DeviceSingle Point CaneTrekking Pole
Trekking pole (TP).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 CaneNo DeviceSingle Point CaneTrekking Pole

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, 08084, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Donald Barone, DO

    Rowan University School of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research Compliance

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 28, 2014

Study Start

April 1, 2014

Primary Completion

March 7, 2019

Study Completion

March 7, 2019

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)