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Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

M

Mount Sinai Rehabilitation Hospital

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Other: Forwards Walking
Other: Backwards Walking

Study type

Interventional

Funder types

Other

Identifiers

NCT02759211
SFH-16-27

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Forwards Walking Group (FWG)
Active Comparator group
Description:
The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Treatment:
Other: Forwards Walking
Backwards Walking Group (BWG)
Experimental group
Description:
The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Treatment:
Other: Backwards Walking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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