View Clinical Trial (Medical Research Study)
Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
| City: |
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Charlotte |
| State: |
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North Carolina |
| Zip Code: |
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28207 |
| Conditions: |
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Amyotrophic Lateral Sclerosis - Motor Neuron Disease - Lou Gehrig's Disease |
| Purpose: |
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The purpose of this study is to find out if supervised exercise training using a treadmill
with partial weight support is safe and has an impact on gait and function of persons with
Amyotrophic lateral sclerosis.
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| Study Summary: |
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Twenty ALS patients who are independent in their transfer with assistive devise such as
walker, cane, or AFO will be offered the opportunity to participate in this study. 20
subjects will be enrolled at Carolinas ALS/Neuromuscular Center at the Carolinas HealthCare
System. Eligible subjects will return for 26 sessions, each lasting between 1-2 hours. At
Session 1 (4 weeks pre-treatment), assessments of muscle strength, spasticity, gait, and
balance will be performed, which will take between 30-60 minutes. At Sessions 2-25,
patients will do supported treadmill ambulation training at a very low speed 3 times a week
for 6 weeks under the supervision of the physical therapist. Each session will have 30
minutes of direct ambulation with the suspension system and treadmill over a 60 minute
period of time. Additionally, at sessions 13 and 26 (4 and 8 weeks post-treatment), the
assessments of muscle strength, spasticity, gait, and balance will be repeated. Needle EMG
to assess denervation potential will be performed at base line and at the conclusion of the
study. The study will last a total of 26 weeks for each patient.
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| Criteria: |
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Inclusion Criteria:
- Clinically probable or definite diagnosis of ALS/MND
- Able to stand independently and ambulate for six minutes with their assistive
devices
- Able to complete the 25 foot walk in less than 1 minute
- Vital Capacity of over 65% predicted
- 25 to 75 years of age
- Not a pregnant woman
- Able to provide informed consent and to comply with training and assessment
procedures
Exclusion Criteria:
- Unstable angina or severe left main coronary disease
- End-stage congestive heart failure
- Severe valvular heart disease
- Malignant or unstable arrhythmias
- Elevated resting blood pressure (systolic, 200mmHg; diastolic, 110mmHg)
- Large or expanding aortic aneurysm
- Known cerebral aneurysm or recent intracranial bleed
- Uncontrolled or end-stage systemic disease
- Acute retinal hemorrhage or recent ophthalmologic surgery
- Acute or unstable musculoskeletal injury
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| NCT ID: |
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NCT00956488 |
| Primary Contact: |
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Jordan E Lyerly, in progress
Phone: 704-355-9434
Email: jordan.lyerly@carolinashealthcare.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Charlotte, North Carolina 28207
United States
Jordan E Lyerly, in progress
Phone: 704-355-9434
Email: jordan.lyerly@carolinashealthcare.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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