NCT01453868

Brief Summary

Standing Balance, with and without blindfold, will be measured on patients with Multiple Sclerosis using a Biodex Balance Scale. A Twelve week intervention with one non impact aerobics group and one control group will be performed. Standing balance will then be retested on all subjects and the results will be statistically compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

5 months

First QC Date

October 13, 2011

Last Update Submit

October 17, 2011

Conditions

Keywords

Multiple Sclerosisnon impact aerobics

Outcome Measures

Primary Outcomes (1)

  • Biodex Scale Balance score: Automated

    A patient will step up to a Biodex Balance scale and will be instructed to try and maintain balance on the machine until it produces an automated outcome score for balance. This number is directly related to a fall risk score in patients with neurological compromise.

    Change: baseline and 12 weeks

Secondary Outcomes (1)

  • Pre and post intervention questionaire

    Change: baseline and 12 weeks

Study Arms (2)

Active non impact aerobics

ACTIVE COMPARATOR

This group will be performing a 12 week non impact aerobics program twice a week.

Other: Non Impact Aerobics

Control group: Passive lecture series

ACTIVE COMPARATOR

The control group will also be measured for balance and then attend a 12 week lecture series with no exercise. They will then also be remeasured post lectures series

Other: Passive : lecture series

Interventions

a 12 week, twice a week class in non impact aerobics

Also known as: Dancing, NIA, MS
Active non impact aerobics

a 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis

Also known as: Lifestyle lectures, symptom management
Control group: Passive lecture series

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients that were diagnosed by a neurologist with Relapsing Remitting Multiple Sclerosis.
  • EDSS scale between 1 and 6.
  • Patients that are able to travel to and from a 12 week program location.

You may not qualify if:

  • Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
  • EDSS scale above 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthZone Chiropractic Clinic

Gaylord, Michigan, 49735, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Donovan Adendorf, DC

    Nelson Mandela Metropole University, Department of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Rosa DuRandt, PhD

    Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa

    STUDY DIRECTOR
  • Maryna Baard, PhD

    Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa

    STUDY CHAIR

Central Study Contacts

Donovan Adendorf, DC

CONTACT

Donovan Adendorf

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Donovan Adendorf

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 18, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations