NCT02274935

Brief Summary

This study examines the effect of balance and walking exercise on cognition and mobility in people with Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

October 22, 2014

Last Update Submit

October 25, 2016

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Cognitive Motor interference

    This will be operationalized as the percent change in walking velocity from single (walking only) to dual task (walking while thinking). Participants will complete a total of 8 walking trials over a 20' pressure sensitive (Zeno™) walkway. Four at a comfortable walking speed and four as fast as possible. Half of the trials at each speed will be conducted while reciting every other letter of the alphabet (i.e. N, P, R, etc).

    12 weeks

Study Arms (2)

Gait and balance exercise

EXPERIMENTAL

Traditional exercises focusing on gait and balance

Other: Exercise

Cognitive training and physical exercise

EXPERIMENTAL

Gait and balance exercises done in combination with cognitive training (i.e. counting backwards by 7s from 98)

Other: Exercise

Interventions

ExerciseOTHER

Balance and gait exercise twice a week for an hour

Also known as: Physical Rehabilitation
Cognitive training and physical exerciseGait and balance exercise

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motor control research lab

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jacob Sosnoff, PhD

    Associate Professor, University of Illinois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

US(1)