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Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Backwards Walking
Forwards Walking
Sponsored by
Mount Sinai Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator

Sites / Locations

  • Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Forwards Walking Group (FWG)

Backwards Walking Group (BWG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Spatiotemporal Walking Parameters from Gaitrite Mat
Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Gait Speed (Timed 25 Foot Walk)
Timed 25 Foot Walk
Single Leg Stance (SLS)

Secondary Outcome Measures

Timed-up and Go
Activities-Specific Balance Confidence Scale (ABC)

Full Information

First Posted
March 22, 2016
Last Updated
August 28, 2017
Sponsor
Mount Sinai Rehabilitation Hospital
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT02759211
Brief Title
Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
Official Title
Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Rehabilitation Hospital
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Forwards Walking Group (FWG)
Arm Type
Active Comparator
Arm Description
The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Arm Title
Backwards Walking Group (BWG)
Arm Type
Experimental
Arm Description
The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Intervention Type
Other
Intervention Name(s)
Backwards Walking
Intervention Description
The Backwards Walking Group will perform backwards walking for the entire treatment intervention.
Intervention Type
Other
Intervention Name(s)
Forwards Walking
Intervention Description
The Forwards Walking Group will perform forwards walking for the entire treatment intervention.
Primary Outcome Measure Information:
Title
Spatiotemporal Walking Parameters from Gaitrite Mat
Description
Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Time Frame
Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
Title
Gait Speed (Timed 25 Foot Walk)
Description
Timed 25 Foot Walk
Time Frame
Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention
Title
Single Leg Stance (SLS)
Time Frame
Change in Baseline SLS after 8 week intervention
Secondary Outcome Measure Information:
Title
Timed-up and Go
Time Frame
Change in Baseline TUG after 8 week intervention
Title
Activities-Specific Balance Confidence Scale (ABC)
Time Frame
Change in Baseline ABC after 8 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Ruiz, DPT
Phone
860-714-2149

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

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