Supported Treadmill Ambulation Training (STAT) for Patients Diagnosed With Amyotrophic Lateral Aclerosis

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease; Motor Neuron Disease
• Interventions: Behavioral: Treadmill Exercise

• Registration Number: NCT00956488
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2013-07
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
supported treadmill ambulation training	Treadmill Exercise	-

Primary Outcome Measures

Name	Time	Method
Twenty Five Foot Walk Test (25FWT)	baseline, after 4 weaks and 8 weaks post training
The Six-Minute Walk Test (6MWT)	baseline, after 4 weaks and 8 weaks post training
Fatigue severity scale (FSS)	baseline, after 4 weaks and 8 weaks post training

Secondary Outcome Measures

Name	Time	Method
Muscle strength	baseline, after 4 weaks and 8 weaks post training
ALS functional rating scale (ALSFRS-R)	baseline, after 4 weaks and 8 weaks post training
Vital Capacity	baseline, after 4 weaks and 8 weaks post training
Beck Depression Inventory (BDI)	baseline, after 4 weaks and 8 weaks post training

Trial Locations

Locations (1)

Carolinas ALS Clinical Resarch Center; 🇺🇸 Charlotte, North Carolina, United States