Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Forwards Walking; Other: Backwards Walking

• Registration Number: NCT02759211
• Lead Sponsor: Mount Sinai Rehabilitation Hospital

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 available

Study Timeline

• Study First Submitted: 2016-03-22
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-30
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forwards Walking Group (FWG)	Forwards Walking	The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.
Backwards Walking Group (BWG)	Backwards Walking	The intervention will consist of three (3), treadmill exercise sessions per week, for eight (8) weeks, for a total of 24 exercise sessions.

Primary Outcome Measures

Name	Time	Method
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
Single Leg Stance (SLS)	Change in Baseline SLS after 8 week intervention
Gait Speed (Timed 25 Foot Walk)	Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention	Timed 25 Foot Walk

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital; 🇺🇸 Hartford, Connecticut, United States