Recruiting

Backwards Walking

Sponsor:

Mount Sinai Rehabilitation Hospital

Code:

NCT02759211

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Backwards Walking

Forwards Walking

Study Details

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

Study ID

NCT02759211

Start date

Apr, 2016

Status verified date

Aug, 2017

Completion date

Feb, 2018

Anticipated

Primary completion date

Feb, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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that cannot adhere to the protocol, have an abnormal response to exercise, or is determined to be unsafe may be withdrawn at the discretion of the Principal Investigator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

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Backwards Walking

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

Forwards Walking

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

Primary outcome measure

  • Spatiotemporal Walking Parameters from Gaitrite Mat [ Time Frame: 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 ]
  • Single Leg Stance (SLS) [ Time Frame: Change in Baseline SLS after 8 week intervention ]

Central Contacts and Locations

Locations

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital

Recruiting

Hartford, Connecticut, United States, 06112

Contacts

Jennifer Ruiz, DPT

860-714-2149

More Information

Sponsor

Mount Sinai Rehabilitation Hospital

Last update posted

Aug 30, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Rehabilitation Hospital on 2017-08-30.