StrokeNCT00975156

Improving Ambulation Post Stroke With Robotic Training

A study testing Physical Therapy and Lokomat in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Stroke
What is being tested?: Physical Therapy and Lokomat
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: May 2008to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
Age>18
At least 3 months post stroke at time of enrollment into study
Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently
Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4
Ability to perform Lokomat ambulation training with assistance of 1 therapist

Show all 10Show fewer

Ability to follow a three-step command
Physician approval for patient participation
Ability to give informed consent
Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies

Who cannot join

Serious cardiac condition
Uncontrolled blood pressure, defined as > 200 or diastolic > 100 at rest
Hx of serious chronic obstructive pulmonary disease or oxygen dependence
Sever weight bearing pain
Lower extremity amputation
Claudication while walking

Show all 10Show fewer

Life expectancy < 1 year
History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months
Severe orthopedic problem
Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Memorial Hermann
Houston, Texas, 77030

Other trials in United States

About this study

The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.

Conditions: Stroke
Being tested: Physical Therapy, Lokomat
Medical subject headings: Stroke

What participants receive

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

Physical TherapyOther
Conventional physical therapy
LokomatDevice
Robotic-assisted walking device

Study groups in NCT00975156
Study group	Role	What they receive
Lokomat Intervention	Experimental	Lokomat gait training (five days a week for eight weeks for a total of 40 sessions). Receives: Device: Lokomat
Standard of Care	Active comparator	Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions. Receives: Other: Physical Therapy

What is being measured

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

10-meter Walking Test (10mWT)
Measured: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Secondary outcomes (1)

6 Minute Walking Distance (6MWD)
Measured: Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Timeline

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

May 2008Oct 2011

First posted11 Sep 2009 (estimated)
Study startMay 2008
Primary completionJul 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00975156
Sponsor's protocol ID: HSC-MH-08-0206
Other IDs: Medallion Grant
Status last verified: Feb 2013
First submitted: 10 Sep 2009
Last updated: 25 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Ambulation Post Stroke With Robotic Training
ClinicalTrials.gov ID: NCT00975156
Acronym / sponsor ID: HSC-MH-08-0206
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: May 2008
Primary completion: Jul 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 11 Sep 2009 (estimated)
Results: Posted 13 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lokomat Intervention	Experimental	Device: LokomatLokomat gait training (five days a week for eight weeks for a total of 40 sessions).
Standard of Care	Active comparator	Other: Physical TherapyConventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
Age>18
At least 3 months post stroke at time of enrollment into study
Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently
Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4

Key exclusion criteria (10 listed)

Serious cardiac condition
Uncontrolled blood pressure, defined as > 200 or diastolic > 100 at rest
Hx of serious chronic obstructive pulmonary disease or oxygen dependence
Sever weight bearing pain
Lower extremity amputation

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
Physical TherapyConventional physical therapy	Other	Standard of Care
LokomatRobotic-assisted walking device	Device	Lokomat Intervention

Primary outcome

10-meter Walking Test (10mWT)
Time frame: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

1 secondary outcome

6 Minute Walking Distance (6MWD)
Time frame: Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Results and safety

Results posted to the registry on 13 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lokomat Intervention	11	11
Standard of Care	10	9

Primary outcome: 10-meter Walking Test (10mWT)

Time frame: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention. Mean (Standard Deviation). Unit: meters per second (m/s)

Measure	Lokomat Intervention 10-meter Walking Test (10mWT) Outcome n = 11	Standard of Care 10mWT Outcome n = 9	All Participants 10mWT Outcome n = 20
Baseline	0.20 (0.10)	0.18 (0.12)	0.19 (0.11)
Post-Intervention (mean=5.05 days post-therapy)	0.20 (0.10)	0.27 (0.27)	0.23 (0.19)
Three-Month Follow-up	0.21 (0.10)	0.28 (0.29)	0.24 (0.20)

Population analysed: Analysis was determined per protocol (i.e.between-group variation)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lokomat Intervention	2 of 11 (18.2%)	5 of 11 (45.5%)	Not reported
Standard of Care	2 of 9 (22.2%)	3 of 9 (33.3%)	Not reported

Limitations and caveats (from the sponsor): Limitations include: small sample (n=21 enrolled, n=20 completed) and significant (p=0.025) difference between groups in time since stroke (Lokomat group, time since stroke mean=1353.60 days; Conventional group, time since stroke mean=525.00 days).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stroke

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

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.

Elizabeth Noser, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Therapy and Lokomat in people with Stroke, run by The University of Texas Health Science Center, Houston 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 10 inclusion and 10 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 25 Feb 2013. 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?

Yes. Results are posted in the registry (first posted 13 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

10-meter Walking Test (10mWT) (time frame: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention). 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 NCT00975156.

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 25 Feb 2013.