Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

NCT02759211 | Unknown

• 1 other identifier: SFH-16-27
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

Forwards Walking Group (FWG)

ACTIVE COMPARATOR

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

Backwards Walking Group (BWG)

EXPERIMENTAL

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

Interventions

Backwards Walking OTHER

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

Backwards Walking Group (BWG)

Forwards Walking OTHER

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

Forwards Walking Group (FWG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Rehabilitation Hospital: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager, Mandell Center for Multiple Sclerosis

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 3, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)