Multiple SclerosisNCT02524483
Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis
A study testing Therapeutic Challenge Program and Therapeutic Exercise Program in people with Multiple Sclerosis, run by University of Nebraska at 1 site in United States.
Trial summary
Outcomes from the investigators' recent investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically improvements in the postural balance and walking speed of individuals with MS. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Therapeutic Challenge Program and Therapeutic Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to 1 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definitive diagnosis of multiple sclerosis
- Kurtzke Expanded Disability Status of 3.0 - 6.5
- Able to walk on a treadmill at a minimum of 0.5 miles per hour while holding onto handrails
- Cognitively and emotionally competent
- A Mini-Mental State Examination score > 21
- Composite score on the computerized Sensory Organization Test of < 70
Who cannot join
- Documented MS-related relapse in the previous 6 months
- Major MS-specific medication changes within the previous 3 months
- Presence of another major co-morbidity such as neurological disorders, uncontrolled pain, hypertension, and diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center, Monroe-Meyer Institute
Omaha, Nebraska, 68106
About this study
Official title: Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis Influence of High-Dosage Physical Therapy on the Balance and Mobility of Individuals With Multiple Sclerosis
Outcomes from the investigators' recent investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically improvements in the postural balance and walking speed of individuals with MS.
This investigation will evaluate mobility and postural balance improvements in individuals with MS who participate in a therapeutic protocol consisting of activity based exercises, and in individuals with MS that participate in challenging physical therapy protocol.
Read the detailed description
Background: Outcomes from the investigators' recent exploratory investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically relevant improvements in the postural balance and walking speed of individuals with MS.
Objective: The investigators anticipated that the promising results were due to the novel challenging postural balance and mobility exercises. The purpose of this investigation was to test this notion by evaluating the mobility and postural balance improvements that could be achieved in a cohort of individuals with MS who participated in a therapeutic protocol that consisted of activity based exercises, and a cohort of individuals with MS that participated in the challenging physical therapy protocol.
- Conditions
- Multiple Sclerosis
- Being tested
- Therapeutic Challenge Program, Therapeutic Exercise Program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Challenge ProgramBehavioural
The Therapeutic Challenge Program will consist of a 5 minute warm-up, 20 minutes of challenging balance training, and 20 minutes of challenging treadmill and overground walking.
Therapeutic Exercise ProgramBehavioural
The Therapeutic Exercise Program will consist of 15 minutes of strength training and flexibility exercises, 15 minutes of balance exercises, and 15 minutes of treadmill walking.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Challenge Group | Experimental | The Therapeutic Challenge Group will complete the Therapeutic Challenge Program twice a day, five days each week for 6 weeks. Receives: Behavioral: Therapeutic Challenge Program |
| Therapeutic Exercise Group | Active comparator | The Therapeutic Exercise Group will complete the Therapeutic Exercise Program twice a day, five days each week for 6 weeks. Receives: Behavioral: Therapeutic Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Balance Using the Sensory Organization Test
The Sensory Organization Test consists of six different conditions that measure each subject's ability to integrate visual, somatosensory, and vestibular feedback to reduce the overall amount of postural sway and improve balance.
Measured: Baseline and 6 weeks
Changes in Walking Velocity, Step Lengths, Step Widths, and Cadence
The changes in walking velocity, step lengths, step widths, and cadence will be quantified using a GaitRITE digital mat.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Changes in Endurance using the 6-Minute Walk
The changes in endurance will be evaluated using the total distance walking during a 6 minute time frame.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start1 Oct 2014
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max J Kurz, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524483
- Sponsor's protocol ID
- 0467-14-EP
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2015
- Last updated
- 5 Sep 2023
- Results posted
- No
Publications
Davies BL, Arpin DJ, Liu M, Reelfs H, Volkman KG, Healey K, Zabad R, Kurz MJ. Two Different Types of High-Frequency Physical Therapy Promote Improvements in the Balance and Mobility of Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Dec;97(12):2095-2101.e3. doi: 10.1016/j.apmr.2016.05.024. Epub 2016 Jul 1.
PubMed 27373745
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Exercise on the Mobility and Balance of Individuals With Multiple Sclerosis Influence of High-Dosage Physical Therapy on the Balance and Mobility of Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02524483
- Acronym / sponsor ID
- 0467-14-EP
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Outcomes from the investigators' recent investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically improvements in the postural balance and walking speed of individuals with MS.
This investigation will evaluate mobility and postural balance improvements in individuals with MS who participate in a therapeutic protocol consisting of activity based exercises, and in individuals with MS that participate in challenging physical therapy protocol.
Detailed description
Background: Outcomes from the investigators' recent exploratory investigation suggested that a high dosage of challenging physical therapy exercises can result in clinically relevant improvements in the postural balance and walking speed of individuals with MS.
Objective: The investigators anticipated that the promising results were due to the novel challenging postural balance and mobility exercises. The purpose of this investigation was to test this notion by evaluating the mobility and postural balance improvements that could be achieved in a cohort of individuals with MS who participated in a therapeutic protocol that consisted of activity based exercises, and a cohort of individuals with MS that participated in the challenging physical therapy protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Challenge Group | Experimental | Behavioral: Therapeutic Challenge ProgramThe Therapeutic Challenge Group will complete the Therapeutic Challenge Program twice a day, five days each week for 6 weeks. |
| Therapeutic Exercise Group | Active comparator | Behavioral: Therapeutic Exercise ProgramThe Therapeutic Exercise Group will complete the Therapeutic Exercise Program twice a day, five days each week for 6 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Definitive diagnosis of multiple sclerosis
- Kurtzke Expanded Disability Status of 3.0 - 6.5
- Able to walk on a treadmill at a minimum of 0.5 miles per hour while holding onto handrails
- Cognitively and emotionally competent
- A Mini-Mental State Examination score > 21
Key exclusion criteria (3 listed)
- Documented MS-related relapse in the previous 6 months
- Major MS-specific medication changes within the previous 3 months
- Presence of another major co-morbidity such as neurological disorders, uncontrolled pain, hypertension, and diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Challenge ProgramThe Therapeutic Challenge Program will consist of a 5 minute warm-up, 20 minutes of challenging balance training, and 20 minutes of challenging treadmill and overground walking. | Behavioural | Therapeutic Challenge Group |
| Therapeutic Exercise ProgramThe Therapeutic Exercise Program will consist of 15 minutes of strength training and flexibility exercises, 15 minutes of balance exercises, and 15 minutes of treadmill walking. | Behavioural | Therapeutic Exercise Group |
Primary outcome
Changes in Balance Using the Sensory Organization Test
Time frame: Baseline and 6 weeks
The Sensory Organization Test consists of six different conditions that measure each subject's ability to integrate visual, somatosensory, and vestibular feedback to reduce the overall amount of postural sway and improve balance.
Changes in Walking Velocity, Step Lengths, Step Widths, and Cadence
Time frame: Baseline and 6 weeks
The changes in walking velocity, step lengths, step widths, and cadence will be quantified using a GaitRITE digital mat.
1 secondary outcome
Changes in Endurance using the 6-Minute Walk
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 27373745Davies BL, Arpin DJ, Liu M, Reelfs H, Volkman KG, Healey K, Zabad R, Kurz MJ. Two Different Types of High-Frequency Physical Therapy Promote Improvements in the Balance and Mobility of Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Dec;97(12):2095-2101.e3. doi: 10.1016/j.apmr.2016.05.024. Epub 2016 Jul 1.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max J Kurz, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Challenge Program and Therapeutic Exercise Program in people with Multiple Sclerosis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Balance Using the Sensory Organization Test (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.