Functional and Physiological Responses to Lokomat Therapy (Pilot Study)

Description of the Clinical Lokomat Therapy program:

This is a 12-week program with 3 to 5 sessions per week. Each session includes: 15-20
minutes of patient set-up (set-up time becomes about 5 to 10 minutes after a few sessions),
5-10 minutes of warm-up, 20-40 minutes of Lokomat therapy, 5-10 minutes of cool-down, and
5-10 minutes to remove the patient from the system. During the Lokomat sessions, heart rate
and blood pressure are monitored by the therapist and recorded. Work performed is measured
and recorded in the Lokomat computer for time, speed, amount of weight bearing, and
distance.

Description of the Research Component:

A pre and post, prospective study design will be employed. Baseline measurements (Please
see below and Table 1 for detailed descriptions) will be performed prior to start of the
Lokomat therapy program and then again after completion of the 12-week program. A chart
review will be performed at baseline only for documentation of medical history and
medications. In a subset of patients a muscle biopsy will be performed for gene expression
at baseline and week 12.

As part of Clinical Care, during each of the Lokomat therapy sessions the following
information is collected:

1. Work (total time, speed, distance, amount of weight bearing)

2. Heart rate (HR)

3. Blood Pressure (SBP, DBP)

4. Perception of exertion (Borg Scale)

5. Lipid profile (pre and post)

6. Albumin (pre and post)

For Research purposes the following is being proposed:

Review and record work, HR, BP, Borg Scale from all clinical sessions

Baseline and Week 12 measurements (performed on a separate days or prior to the sessions):

1. Resting energy expenditure (REE)

2. Body Composition [dual energy x-ray absorptiometry (DEXA) ) - [scans include total
body, dual femur, and the knee], partial body potassium counting (PBKleg),
bioelectrical impedance analysis (BIA), anthropometric and skin fold measurements]

3. Fasting blood draw for plasma glucose and insulin (FPG, FPI), lipid profile,
testosterone, sex hormone binding globulin (SHBG), insulin-like growth factor 1
(IGF-1), bone markers, coagulation factors, platelet aggregation, 2 hour standard oral
glucose tolerance testing (OGTT) with insulin levels.

4. Autonomic and blood pressure regulation studies [resting and tilt table provocation,
for heart rate and blood pressure variability (HRV, BPV), arterial blood flow, and
venous occlusion]

5. Disability-specific quality of life (QOL) and activities of daily living surveys
[GI-Bowel survey, brief pain inventory (BPI), fatigue survey, spasticity scale, mini
mental status exam (MMSE)]. These disease-specific QOLs will include the question "How
do you rate your general health and well-being over the past week?" A Lickert scale
response will be incorporated.

6. Functional Mobility Assessment

7. Muscle biopsy for gene expression (subset of patients only).

Inclusion Criteria:

The inclusion criteria are based on the guidelines set by the clinical Lokomat therapy
program.

1. Patients will have been evaluated on the Rehabilitation Service for entry into the
clinical therapy program.

2. Any patient who is already eligible for Lokomat therapy is a candidate for this
research project.

Exclusion Criteria:

1. Pregnant women

2. History of fractures of the lower extremities

3. Bone density study indicating bone loss greater than 5 standard deviations from
normal.

4. Fixed contractures of the ankles, knees or hips

5. Uncontrolled spasticity that significantly interferes with movement of lower
extremities.

6. Uncooperative, unmotivated patients or patients whom cannot follow instructions on a
consistent basis or communicate effectively with the treating clinicians.

7. Pressure ulcers over the greater trochanters, ischial tuberosities and sacrum.

8. Weight greater than 250 lbs

9. severe orthostatic hypotension (drop in blood pressure more than 30mm Hg when moving
from sitting to standing posture)

10. Acute medical illness (i.e. infection)

11. Recently documented DVT in lower extremities

12. SCI ASIA's A and B