A Phase 1/2 interventional study of Treadmill Exercise in Amyotrophic Lateral Sclerosis, Motor Neuron Disease and Lou Gehrig's Disease, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Wake Forest University Health Sciences · Phase 1/2, Interventional, and Prevention
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.
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 9 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences