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Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Sclerosis |
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Study Focus:
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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Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS |
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Study Category:
Other: Exercise |
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Study Status:
Active, currently recruiting |
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Phase:
Phase I |
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Type:
Interventional Trial
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Funding Source:
Carolinas Healthcare System |
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Study Chair(s)/Principal Investigator(s):
Mohammed Sanjak PhD, PT, (Carolinas Healthcare System) |
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Clinicaltrials.gov ID:
NCT00956488 |
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NEALS Affiliated?
No |
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Study Summary:
The intervention will consist of 30 minutes of exercise, performed 3 times per week for 8 weeks (24 sessions). Patient will walk on a treadmill with up to 40% of their body weight supported by a body weight support system with an overhead harness. The training session duration will be 60 minutes consisting of six intervals of 5 minutes exercise, interspersed with 6 intervals of 5 minutes rest to avoid overwork weakness and fatigue. Five minute exercise intervals should be sufficient for patients to reach a steady state. Patients will build up their endurance to this training level at their own pace as tolerated. Walking speed will be determined as tolerated by each patient. Exercise intensity will be guided by each patient's own perception of exertion, but not to exceed level 12-13 (mild to moderate) on the modified Borg perceived exertion scale, and by oxygen saturation (Sa O2) ≥ 90% monitor by handheld pulse Oximeter.
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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Participant Duration:
26 weeks |
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# of Subjects:
20 |
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Enrollment Start Date:
09/01/2008 |
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Enrollment End Date:
12/01/-0001 |
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Posting Last Modified Date:
11/01/2011 |
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Date Study Added to alscortium.org:
11/03/2011 |
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| Eligibility Criteria |
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Gender:
Male & Female |
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Minimum Age:
25 |
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Maximum Age:
75 |
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Min Vital Capacity (% predicted normal):
65% |
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Coordinating Center
Contact Information |
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| Jordan E Lyerly |
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| jordan.lyerly@carolinashealthcare.org |
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| 704-355-9434 |
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| Carolinas ALS Clinical Resarch Center |
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1010 Edgehill Road North
Charlotte, North Carolina 28207
UNITED STATES |
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Other Eligibility Criteria:
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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Site Contact Information (Please click to show/hide) |
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| North Carolina |
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Carolinas ALS Clinical Resarch Center
Jordan E Lyerly
jordan.lyerly@carolinashealthcare.org
704-355-9434
1010 Edgehill Road North
Charlotte, North Carolina 28207
UNITED STATES |
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Familial ALS- ALS cases are inherited from 2 or more family members, affects 5-10% of ALS cases. Sporadic ALS- disease occurs at random with no clearly associated risk factors; most common form of ALS, affects approximately 90-95% ALS cases. Interventional trial- study where exposure, for example a drug, is assigned; used to determine the effectiveness of a treatment or intervention. With drugs and a placebo- One group gets the active treatment, the other gets the placebo. Everything else is held the same between the two groups, so that any difference in their outcome can be attributed to the active treatment. Observational study- study in which patients are observed and where no treatment is given; researcher has no control over the experiment because they are done in a more natural setting than an interventional trial. Trial Phase- objectives are different for each phase of a trial. - Phase I, drug is given to a small number of people to see if it is safe.
- Phase II begins to look at effectiveness of the drug.
- Phase III is considered the definitive test of whether a drug is effective, held at multiple research sites and much larger than the previous phases.
Vital Capacity- the maximum amount of air that can be expelled from the lungs after a maximum drawing of air into the lungs, measured by a spirometer and then scored as a percentage. |
