CompletedNCT00975156Updated Feb 25, 2013Results posted

Improving Ambulation Post Stroke With Robotic Training

An interventional study of Physical Therapy and Lokomat in Stroke, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study summary

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 studied

Stroke

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Stroke 7,286

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 21 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

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Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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
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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 21 participants (actual)

Study arms

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

Interventions

OtherPhysical Therapy
Conventional physical therapy
DeviceLokomat
Robotic-assisted walking device

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Posted Sep 13, 2012

Limitations and caveats

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).

Participant flow

Participant flow — Overall Study
Milestone	Lokomat Intervention	Standard of Care
Started	11	10
Completed	11	9
Not completed	0	1
Withdrew: Protocol violation	0	1

Outcome measures

Primary10-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
Reported as:: Mean · meters per second (m/s)

10-meter Walking Test (10mWT)
meters per second (m/s)	Lokomat Intervention 10-meter Walking Test (10mWT) Outcome	Standard of Care 10mWT Outcome	All Participants 10mWT Outcome
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

Secondary6 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
Reported as:: Mean · meters (m)

6 Minute Walking Distance (6MWD)
meters (m)	Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome	Standard of Care 6MWD Outcome	All Participants 6MWD Outcome
Baseline	53.94 ± 30.53	48.77 ± 21.04	51.61 ± 26.16
Post-Intervention (mean=5.05 days post-therapy)	57.02 ± 25.50	70.26 ± 60.40	62.98 ± 43.86
Three-Month Follow-up	57.82 ± 25.99	76.89 ± 62.29	66.40 ± 45.65

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lokomat Intervention	—	2/11 (18.2%)	5/11 (45.5%)
Standard of Care	—	2/9 (22.2%)	3/9 (33.3%)

Most frequent serious events

Most frequent serious events
Event	Lokomat Intervention	Standard of Care
Hypotensive episodeCardiac disorders	0/11	1/9
Chest painCardiac disorders	0/11	1/9
Skin breakdownSkin and subcutaneous tissue disorders	1/11	0/9
StrokeVascular disorders	1/11	0/9

Most frequent other events

Most frequent other events
Event	Lokomat Intervention	Standard of Care
Minor skin breakdownSkin and subcutaneous tissue disorders	5/11	3/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Lokomat Intervention	Standard of Care	Total
<=18 years	0	0	0
Between 18 and 65 years	4	5	9
>=65 years	7	5	12

Age Continuous
Age Continuous(years)	Lokomat Intervention	Standard of Care	Total
Mean	66.91 ± 8.50	64.33 ± 10.91	65.75 ± 9.48

Sex: Female, Male
Sex: Female, Male(Participants)	Lokomat Intervention	Standard of Care	Total
Female	4	4	8
Male	7	6	13

Region of Enrollment
Region of Enrollment(participants)	Lokomat Intervention	Standard of Care	Total
United States	11	10	21

Study locations

1 site

Memorial Hermann
Houston, Texas 77030, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00975156
Lead sponsor: The University of Texas Health Science Center, Houston
Responsible party: Elizabeth Noser (Clinical Assistant Professor - Neurology, The University of Texas Health Science Center, Houston) — Principal investigator
First posted: Sep 11, 2009
Start date: May 2008
Primary completion: Jul 2011
Completion: Oct 2011
Results posted: Sep 13, 2012
Last update: Feb 25, 2013

Study contacts

Elizabeth Noser, MD

principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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