Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

NCT ID: NCT02759211

Last Updated: 2017-08-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-28

Brief Summary

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There have been no published studies to date on the effects of backwards walking in persons with MS. Thus it is important that the investigators explore different methods for treatment to help improve balance and gait and prevent injury in persons with MS with gait disturbances and balance impairments.The overall goal of this research is to collect pilot data on the effectiveness of backwards walking as a therapy for improving spatiotemporal, clinical gait and balance assessments in persons with Multiple Sclerosis compared to forward walking.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Forwards Walking Group (FWG)

The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.

Group Type ACTIVE_COMPARATOR

Forwards Walking

Intervention Type OTHER

The Forwards Walking Group will perform forwards walking for the entire treatment intervention.

Backwards Walking Group (BWG)

The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.

Group Type EXPERIMENTAL

Backwards Walking

Intervention Type OTHER

The Backwards Walking Group will perform backwards walking for the entire treatment intervention.

Interventions

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Backwards Walking

The Backwards Walking Group will perform backwards walking for the entire treatment intervention.

Intervention Type OTHER

Forwards Walking

The Forwards Walking Group will perform forwards walking for the entire treatment intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed clinical diagnosis of MS
* Cognitively able to understand directions and complete protocol (score of 22 or greater on MMSE)
* Signed Consent form approved by the Saint Francis Institutional Review Board
* 18-65 years of age
* PDDS score of 3 to 5 during the past 12 months
* Completion of the 6 minute walk test
* Speaks English (in order to safely complete intervention)

Exclusion Criteria

* Unwilling or unable to complete assessments and intervention
* Current participation in physical therapy
* Major changes in exercise habits in the past three months
* Has had a relapse, acute Solumedrol treatment, or Acthar treatment in the past two months
* Requires constant bilateral assistance (canes or crutches) for ambulation and/or cannot walk at least 100 meters without resting
* Current self-reported medical history of unstable angina, uncontrolled cardiac dysrhythmias causing symptoms, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, history of DVT, acute myocarditis or pericarditis, acute systemic infection, uncontrolled hypertension, and uncontrolled diabetes \[11\]
* Participants that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Mount Sinai Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Ruiz, DPT

Research Manager, Mandell Center for Multiple Sclerosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jennifer Ruiz, DPT

Role: primary

860-714-2149

Other Identifiers

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SFH-16-27

Identifier Type: -

Identifier Source: org_study_id

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