AzTrials
AzTrials

Multiple SclerosisNCT01339234

Supported Treadmill Training for Progressive Multiple Sclerosis

A study testing Body-weight supported treadmill training in people with Multiple Sclerosis, run by Hicks, Audrey, Ph.D. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a pilot trial to evaluate the effects of supported treadmill walking in patients with primary progressive multiple sclerosis (MS) on functional and psychosocial outcomes. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Body-weight supported treadmill training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
Apr 2008to Jun 2009
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed, written informed consent
  • Males or non-pregnant females, 18-60 years of age (inclusive)
  • Clinically definite PPMS as per the diagnostic criteria of Thompson et al (2000)
  • Expanded disability status score 5.0-8.0 (constant assistance required)
  • Body weight <90kg (due to support limitations of treadmill)
  • Approval from physician to participate in the exercise program
Show all 9Show fewer
  • Ability to tolerate upright locomotion of the body weight supported treadmill
  • Ability to visit the different sites required for the study
  • Ability to commit to 3 weekly training sessions for the duration of 24 weeks

Who cannot join

  • Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
  • Any other serious medical condition that might impair the subject's ability to walk on a treadmill and/or participate in aerobic exercise (including but not limited to: documented heart disease or unstable angina, uncontrolled cardiac dysrhythmia, chronic obstructive lung disease, recent non-traumatic fracture, osteoporosis and severe skin ulcerations)
  • Female patients who do not agree to use effective contraceptive method(s) during the study
  • Current use or use within the last 2 months of any on- or off-label disease-modifying therapy including IFN-β, glatiramer acetate, IV steroids, mitoxantrone, azathioprine, and cyclophosphamide
  • Previous experience with supported treadmill training
  • Kidney disease, peripheral vascular disease or poor circulation
  • Inability to undergo MRI or MRI with gadolinium administration

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University (Centre for Health Promotion and Rehabilitation)/Hamilton Health Sciences

    Hamilton, Ontario, L8S 4K1

Other trials in Canada

About this study

Official title: Body-weight Supported Treadmill Training in Primary Progressive Multiple Sclerosis: A Pilot Trial

This study is a pilot trial to evaluate the effects of supported treadmill walking in patients with primary progressive multiple sclerosis (MS) on functional and psychosocial outcomes. Patients will exercise three times per week over the course of 6 months and will be evaluated at baseline, 12 weeks and 24 weeks into the program. Follow-up testing will also be conducted 12 weeks after participants have stopped exercising to determined the lasting effects of the intervention.

The investigators hypothesize that supported treadmill walking will be effective at improving physical physical function and psychosocial outcomes in patients with primary progressive MS.

Read the detailed description

The use of exercise as an adjunct to other disease modifying treatments in MS has found increasing support over the past decade. There is ample evidence that exercise therapy can improve physical measures of disability in MS, in addition to being safe and well-tolerated. However, there is a paucity of data on whether exercise is equally effective for those with primary progressive MS as it is in relapsing remitting MS. In addition, studies of exercise therapy have traditionally excluded MS patients with severe disability. There are also currently no treatments for primary progressive MS, so finding a safe disease-modifying therapy is of the utmost importance. The investigators are therefore conducting a pilot trial to evaluate the effects of exercise in the form of supported treadmill walking for patients with primary progressive MS with severe functional impairments.

Six patients with primary progressive MS with high disability level will be recruited to participate in this study. Participants will exercise using body-weight supported treadmill training (BWSTT; Woodway Loco-system) which allows a portion of an individual's body-weight to be counterbalanced by an overhead pulley system. This system allows patients with limited mobility to walk upright on the treadmill with therapist assistance. Therapists trained in using the BWSTT system will guide the patients' legs through a proper gait motion and assist with lower limb control. Participants will complete 72 training sessions (30min/session, 3x/week) over the course of 24 weeks. Participants will be evaluated at baseline, 12 weeks (half-way through the training program) and 24 weeks (end of intervention). A follow-up assessment will also be performed 12 after participants have completed the training program (36 weeks). Outcome measures are described below.

Being tested
Body-weight supported treadmill training
Keywords
treadmill exercise, rehabilitation, progressive multiple sclerosis, functional ability, quality of life, fatigue
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Body-weight supported treadmill trainingOther

    Patients will undergo training using the Woodway Loco-system which consists of a treadmill with an overhead pulley system connected to a support harness. BWSTT allows patients with limited mobility to safely walk upright on a treadmill with a portion of their body weight counter balanced. Three trainers will be required to assist with the BWSTT program. Two trainers will be positioned at the lower limbs to manually guide the participant through a proper gait motion and provided lower limb control. A third trainer will stand behind the participant to provide trunk support and assist with weight shifting.

Study groups in NCT01339234
Study groupRoleWhat they receive
Body-weight supported treadmill trainingExperimentalNot described
Receives: Other: Body-weight supported treadmill training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Multiple Sclerosis Functional Composite (MSFC) at 12, 24 and 36 weeks

    The MSFC assesses functional ability with three scales: the 25ft walk (leg strength and ambulation), the 9-hole peg test (arm strength and coordination) and the Paced Auditory Serial Addition Test (PASAT; cognition). Scores on all three measures are combined to produce a composite Z-score.

    Measured: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

Secondary outcomes (5)

  1. Change from baseline in Expanded Disability Status Scale (EDSS) at 12, 24 and 36 weeks

    The EDSS provides a measure of physical and neurological function specifically in MS patients and is scored from 0-10. This will be assessed by a train neurologist.

    Measured: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

  2. Change from baseline in Modified Fatigue Impact Scale (MFIS) at 12, 24 and 36 weeks

    The MFIS is a 21-item self-report questionnaire that evaluates fatigue overall fatigue, as well as within three categories: physical (pMFIS); cognitive (cMFIS); and psychosocial (psMFIS), over the previous 4 weeks. Scores range from 0-4 on each item with a maximum total score of 84, where higher scores indicate greater fatigue levels.

    Measured: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

  3. Change from baseline in Multiple Sclerosis Quality of Life-54 questionnaire at 12, 24 and 36 weeks

    The MSQOL-54 is an MS-specific measure of quality of life that consists of 54 items divided into 12 multi-item scales, 2 single-item scales, and 2 composite scores (physical and mental health).

    Measured: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

  4. Change from baseline in brain-derived neurotrophic factor (BDNF) at 12, 24 and 36 weeks

    Measured: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)

  5. Change from baseline in magnetic resonance imaging (MRI) outcomes at 24 weeks

    Both standard and unconventional MRI techniques will be used to evaluate the effects of exercise on brain health.

    Measured: Repeat assessments: baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2011 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01339234
Sponsor's protocol ID
Hicks -MS treadmill
Status last verified
Apr 2011
First submitted
18 Apr 2011
Last updated
20 Apr 2011
Results posted
No
Data monitoring committee
No

Publications

  • Pilutti LA, Lelli DA, Paulseth JE, Crome M, Jiang S, Rathbone MP, Hicks AL. Effects of 12 weeks of supported treadmill training on functional ability and quality of life in progressive multiple sclerosis: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):31-6. doi: 10.1016/j.apmr.2010.08.027.

    PubMed 21187202

Questions about this trial

What is this clinical trial studying?

A study testing Body-weight supported treadmill training in people with Multiple Sclerosis, run by Hicks, Audrey, Ph.D. at 1 site in Canada.

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 9 inclusion and 7 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 20 Apr 2011. 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 Canada. 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?

Change from baseline in Multiple Sclerosis Functional Composite (MSFC) at 12, 24 and 36 weeks (time frame: Repeat assessments: baseline, 12 weeks, 24 weeks and 36 weeks (12 weeks post-exercise follow-up)). 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 NCT01339234, 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 20 Apr 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT01339234 | AzTrials