Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Forwards Walking; Other: Backwards Walking

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06112
      • Recruiting
      • Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
      • Contact: Jennifer Ruiz, DPT; Phone Number: 860-714-2149

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Forwards Walking; The Forwards Walking Group will perform forwards walking for the entire treatment intervention.
Experimental: 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.	Other: Backwards Walking; The Backwards Walking Group will perform backwards walking for the entire treatment intervention.

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	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

Collaborators and Investigators

• Sponsor: Mount Sinai Rehabilitation Hospital
• Collaborators: National Multiple Sclerosis Society

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: SFH-16-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO