Effects of Functional Electrical Stimulation Cycling Versus Cycling Only on Walking and Quality of Life in MS

NCT02606604 | Completed Results

• 1 other identifier: 534378-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will seek to determine the benefits that FES-LE cycling has over cycling alone on walking performance and quality of life in people with multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

Functional Electrical Stimulation; Cycling

Outcome Measures

Primary Outcomes (4)

• Gait Velocity: Timed Walking

  Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

  Baseline

• Gait Velocity: Timed Walking

  Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

  4 weeks

• Gait Velocity: Timed Walking

  Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

  8 weeks

• Gait Velocity: Timed Walking

  Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.

  12 weeks

Secondary Outcomes (6)

• Self-reported Fatigue Using Modified Fatigue Impact Scale

  Baseline

• Self-reported Fatigue Using Modified Fatigue Impact Scale

  8 weeks

• Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale

  Baseline

• Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale

  8 weeks

• Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54

  Baseline

Study Arms (2)

FES Cycling

EXPERIMENTAL

The intervention consists of electrical stimulation to five lower extremity muscle groups (quadricep, hamstring, anterior tibialis, gluteal, and gastrocnemius muscle groups) while cycling for 45 minutes, 3 times per week for 8 weeks. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed).

Device: RT 300: Lower Extremity Cycling

Cycling Only

ACTIVE COMPARATOR

The intervention consists of lower extremity cycling for 45 minutes, 3 times per week for 8 weeks. Electrical stimulation will not be applied to any muscles. Outcome measures will be collected at baseline, 4 weeks, 8 weeks and 4 weeks after training is completed.

Device: RT 300: Lower Extremity Cycling

Interventions

RT 300: Lower Extremity Cycling DEVICE

Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks.

Also known as: RT 300, Lower Extremity Ergometer

Cycling Only; FES Cycling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical Diagnosis of MS
• Patient-determined Disease Steps score between 3.0 and 6.0 inclusive
• Ability to attend training sessions 3 times per week for an 8-10 week period
• Passing a submaximal exercise test
• Adequate hip range of motion (at least 110 degrees)
• Adequate knee range of motion (10-90 degrees)

You may not qualify if:

• Cognitive deficits that would interfere in ability to sign consent and understand the procedures for the study.
• History or presence of other neurological pathologies that interfere with movement
• Received physical therapy within the last 4 weeks prior to the study
• History of an acute exacerbation of their MS symptoms within 4 weeks prior to the study
• Immunosuppressive or steroid therapy within the past 4 weeks
• Significant spasticity in the legs that interferes with the cycling motion
• History of congestive heart failure
• Coronary Artery Disease
• Uncontrolled Hypertension
• History of epilepsy or seizures
• Cardiac demand pacemaker or implanted defibrillator
• Unhealed fractures in the legs
• Pressure sores or open wounds on the legs
• Pregnant or trying to conceive

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook Univeristy

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Lori Hochman
• Organization: Stony Brook University

lori.hochman@stonybrook.edu

631-444-1193

Study Officials

• Lori I Hochman, PT, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: November 17, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

US (1)