Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02759211
• Other study ID #: SFH-16-27
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2016
• Last updated: August 28, 2017
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2017
• Source: Mount Sinai Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Rehabilitation Hospital	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gait Speed (Timed 25 Foot Walk)	Timed 25 Foot Walk	Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention
Primary	Single Leg Stance (SLS)		Change in Baseline SLS after 8 week intervention
Secondary	Timed-up and Go		Change in Baseline TUG after 8 week intervention
Secondary	Activities-Specific Balance Confidence Scale (ABC)		Change in Baseline ABC after 8 week intervention