Clinical trial NCT00956488: Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
Official title: Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lou Gehrig's Disease
Keywords: Exercise for Amyotrophic lateral sclerosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 9
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Twenty Five Foot Walk Test (25FWT)
timeFrame: baseline, after 4 weaks and 8 weaks post training
measure: The Six-Minute Walk Test (6MWT)
timeFrame: baseline, after 4 weaks and 8 weaks post training
measure: Fatigue severity scale (FSS)
timeFrame: baseline, after 4 weaks and 8 weaks post training
Secondary outcomes:
measure: Muscle strength
timeFrame: baseline, after 4 weaks and 8 weaks post training
measure: ALS functional rating scale (ALSFRS-R)
timeFrame: baseline, after 4 weaks and 8 weaks post training
measure: Vital Capacity
timeFrame: baseline, after 4 weaks and 8 weaks post training
measure: Beck Depression Inventory (BDI)
timeFrame: baseline, after 4 weaks and 8 weaks post training
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas ALS Clinical Resarch Center
state: North Carolina
Study officials:
References: