Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00956488 |
Recruitment Status :
Completed
First Posted : August 11, 2009
Last Update Posted : April 21, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis Motor Neuron Disease Lou Gehrig's Disease | Behavioral: Treadmill Exercise | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: supported treadmill ambulation training |
Behavioral: Treadmill Exercise
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 Five Foot Walk Test (25FWT) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]
- The Six-Minute Walk Test (6MWT) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]
- Fatigue severity scale (FSS) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]
- Muscle strength [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]
- ALS functional rating scale (ALSFRS-R) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]
- Vital Capacity [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]
- Beck Depression Inventory (BDI) [ Time Frame: baseline, after 4 weaks and 8 weaks post training ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956488
United States, North Carolina | |
Carolinas ALS Clinical Resarch Center | |
Charlotte, North Carolina, United States, 28207 |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT00956488 |
Other Study ID Numbers: |
07-08-15E |
First Posted: | August 11, 2009 Key Record Dates |
Last Update Posted: | April 21, 2022 |
Last Verified: | July 2013 |
Exercise for Amyotrophic lateral sclerosis |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |