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Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

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

Tracking Information
First Submitted Date  ICMJE March 22, 2016
First Posted Date  ICMJE May 3, 2016
Last Update Posted Date August 30, 2017
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • 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
  • 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
  • Single Leg Stance (SLS) [ Time Frame: Change in Baseline SLS after 8 week intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02759211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • Timed-up and Go [ Time Frame: Change in Baseline TUG after 8 week intervention ]
  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: Change in Baseline ABC after 8 week intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
Official Title  ICMJE Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Other: Backwards Walking
    The Backwards Walking Group will perform backwards walking for the entire treatment intervention.
  • Other: Forwards Walking
    The Forwards Walking Group will perform forwards walking for the entire treatment intervention.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Forwards Walking
  • 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.
    Intervention: Other: Backwards Walking
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2016)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02759211
Other Study ID Numbers  ICMJE SFH-16-27
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital
Study Sponsor  ICMJE Mount Sinai Rehabilitation Hospital
Collaborators  ICMJE National Multiple Sclerosis Society
Investigators  ICMJE Not Provided
PRS Account Mount Sinai Rehabilitation Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP