Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

Study Overview
=================
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.

Official Title
-----------------
Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Backwards Walking
* Other: Forwards Walking


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that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Forwards Walking Group (FWG)<br>The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions. | Other: Forwards Walking<br>* The Forwards Walking Group will perform forwards walking for the entire treatment intervention.<br>|
| Experimental: Backwards Walking Group (BWG)<br>The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions. | Other: Backwards Walking<br>* The Backwards Walking Group will perform backwards walking for the entire treatment intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatiotemporal Walking Parameters from Gaitrite Mat | Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention | Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention | 
| Gait Speed (Timed 25 Foot Walk) | Timed 25 Foot Walk | Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention | 
| Single Leg Stance (SLS) |  | Change in Baseline SLS after 8 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed-up and Go |  | Change in Baseline TUG after 8 week intervention | 
| Activities-Specific Balance Confidence Scale (ABC) |  | Change in Baseline ABC after 8 week intervention |