Clinical trial NCT02759211: Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
Official title: Pilot Trial of Backwards Walking in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Mount Sinai Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2016-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Spatiotemporal Walking Parameters from Gaitrite Mat
timeFrame: Change in Baseline Spatiotemporal Walking parameters from Gaitrite Mat after 8 week intervention
measure: Gait Speed (Timed 25 Foot Walk)
timeFrame: Change in f Baseline Gait Speed (Timed 25 Foot Walk) after 8 week intervention
measure: Single Leg Stance (SLS)
timeFrame: Change in Baseline SLS after 8 week intervention
Secondary outcomes:
measure: Timed-up and Go
timeFrame: Change in Baseline TUG after 8 week intervention
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Change in Baseline ABC after 8 week intervention
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Mandell Center for Multiple Sclerosis at the Mount Sinai Rehabilitation Hospital
state: Connecticut
Study officials:
References: