Gait, UnsteadyNCT00835835
Lokomat Treadmill Training Effects on MS Gait
A study testing Body-weight supported treadmill training +/- Lokomat assistance in people with Gait, Unsteady and Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital at 1 site in United States.
Trial summary
This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Gait, Unsteady, Multiple Sclerosis
- What is being tested?
- Body-weight supported treadmill training +/- Lokomat assistance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2013
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Clinical diagnosis of MS
- EDSS level between 3.5-6.0
- Problems with ambulation
- able to ambulate 25 feet without an assistive device
Main Exclusion Criteria:
- Lower extremity injuries that limit range of motion or function
- Unable to demonstrate an understanding of the process of the study and or fully understand instructions in order to safely participate in the study and use study equipment
- Body weight over 150 kg
- complete inclusion/exclusion criteria listed in consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Mandell Center for Multiple Sclerosis at Mt. Sinai Rehabilitation Hospital
Hartford, Connecticut, 06112
About this study
This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis.
- Conditions
- Gait, Unsteady, Multiple Sclerosis
- Being tested
- Body-weight supported treadmill training +/- Lokomat assistance, Usual Care - no active intervention
- Keywords
- Multiple Sclerosis, gait, falls, lokomat, body-weight support treadmill training
- Medical subject headings
- Gait Disorders, Neurologic, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-weight supported treadmill training +/- Lokomat assistanceOther
Also called Lokomat
walking
Usual Care - no active interventionOther
Also called control group
No treatment used for comparison
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The placebo group did not receive treatment during the matched period yet did undergo all assessments. The MS Placebo group received equal treatment following the study intervention period. Receives: Other: Usual Care - no active intervention |
| Combination Treadmill training group | Experimental | Subjects randomized to Combination therapy received 20 minutes of Lokomat assisted treadmill training followed by up to 20 minutes of BWS treadmill training (without robotic assistance) twice a week. Receives: Other: Body-weight supported treadmill training +/- Lokomat assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Parameters
Measured: Baseline, throughout study enrollment and 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionOct 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gait, UnsteadyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Ruiz, DPT, Mount Sinai Rehabilitation Hospital
- Investigators
- Albert Lo, MD, PhD, Principal investigator, Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835835
- Sponsor's protocol ID
- AL0001
- Status last verified
- Nov 2015
- First submitted
- 3 Feb 2009
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fischer JS, LaRocca NG, Miller DM, Ritvo PG, Andrews H, Paty D. Recent developments in the assessment of quality of life in multiple sclerosis (MS). Mult Scler. 1999 Aug;5(4):251-9. doi: 10.1177/135245859900500410.
PubMed 10467384Vellas B, Baumgartner RN, Wayne SJ, Conceicao J, Lafont C, Albarede JL, Garry PJ. Relationship between malnutrition and falls in the elderly. Nutrition. 1992 Mar-Apr;8(2):105-8.
PubMed 1591453Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.
PubMed 2229941Liston RA, Brouwer BJ. Reliability and validity of measures obtained from stroke patients using the Balance Master. Arch Phys Med Rehabil. 1996 May;77(5):425-30. doi: 10.1016/s0003-9993(96)90028-3.
PubMed 8629916
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lokomat Treadmill Training Effects on MS Gait
- ClinicalTrials.gov ID
- NCT00835835
- Acronym / sponsor ID
- AL0001
- Conditions
- Gait, Unsteady, Multiple Sclerosis
- Keywords
- Multiple Sclerosis, gait, falls, lokomat, body-weight support treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mount Sinai Rehabilitation HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Feb 2009 (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.
This study is being done to test the possible benefits of gait-specific training using body-weight supported, Lokomat assisted, treadmill training in people with Multiple Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Usual Care - no active interventionThe placebo group did not receive treatment during the matched period yet did undergo all assessments. The MS Placebo group received equal treatment following the study intervention period. |
| Combination Treadmill training group | Experimental | Other: Body-weight supported treadmill training +/- Lokomat assistanceSubjects randomized to Combination therapy received 20 minutes of Lokomat assisted treadmill training followed by up to 20 minutes of BWS treadmill training (without robotic assistance) twice a week. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Body-weight supported treadmill training +/- Lokomat assistanceAlso: Lokomatwalking | Other | Combination Treadmill training group |
| Usual Care - no active interventionAlso: control groupNo treatment used for comparison | Other | Control group |
Primary outcome
Gait Parameters
Time frame: Baseline, throughout study enrollment and 2 months follow-up
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 11 Nov 2015.
- Background: PubMed 10467384Fischer JS, LaRocca NG, Miller DM, Ritvo PG, Andrews H, Paty D. Recent developments in the assessment of quality of life in multiple sclerosis (MS). Mult Scler. 1999 Aug;5(4):251-9. doi: 10.1177/135245859900500410.
- Background: PubMed 1591453Vellas B, Baumgartner RN, Wayne SJ, Conceicao J, Lafont C, Albarede JL, Garry PJ. Relationship between malnutrition and falls in the elderly. Nutrition. 1992 Mar-Apr;8(2):105-8.
- Background: PubMed 2229941Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.
- Background: PubMed 8629916Liston RA, Brouwer BJ. Reliability and validity of measures obtained from stroke patients using the Balance Master. Arch Phys Med Rehabil. 1996 May;77(5):425-30. doi: 10.1016/s0003-9993(96)90028-3.
- Mandell Center for Multiple Sclerosis home pageLink provided by the sponsor.
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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.
Albert Lo, MD, PhD principal investigator
Mandell Center for Multiple Sclerosis at Mount Sinai Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-weight supported treadmill training +/- Lokomat assistance in people with Gait, Unsteady and Multiple Sclerosis, run by Mount Sinai Rehabilitation Hospital 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?
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 11 Nov 2015. 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. Some participants in this study may receive a placebo. 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?
Gait Parameters (time frame: Baseline, throughout study enrollment and 2 months 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 NCT00835835, which also lists 4 linked publications.
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 11 Nov 2015.