Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT02759211
• Recruitment Status: Unknown
• First Posted: May 3, 2016
• Last Update Posted: August 30, 2017
• Sponsor: Mount Sinai Rehabilitation Hospital
• Collaborator: National Multiple Sclerosis Society
• Information provided by (Responsible Party): Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Other: Backwards Walking; Other: Forwards Walking	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
• Study Start Date: April 2016
• Estimated Primary Completion Date: February 2018
• Estimated Study Completion Date: February 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Spatiotemporal Walking Parameters from Gaitrite Mat [ Time Frame: 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
2. Gait Speed (Timed 25 Foot Walk) [ Time Frame: Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention ]
   Timed 25 Foot Walk
3. Single Leg Stance (SLS) [ Time Frame: Change in Baseline SLS after 8 week intervention ]

Secondary Outcome Measures :

1. Timed-up and Go [ Time Frame: Change in Baseline TUG after 8 week intervention ]
2. Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: Change in Baseline ABC after 8 week intervention ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Connecticut

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital; Recruiting

Hartford, Connecticut, United States, 06112

Contact: Jennifer Ruiz, DPT 860-714-2149

Sponsors and Collaborators

Mount Sinai Rehabilitation Hospital

National Multiple Sclerosis Society

More Information

• Responsible Party: Jennifer Ruiz, DPT, Research Manager, Mandell Center for Multiple Sclerosis, Mount Sinai Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT02759211
• Other Study ID Numbers: SFH-16-27
• First Posted: May 3, 2016
• Last Update Posted: August 30, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases