Study Purpose:
The primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with SOD1 ALS participating in the tofersen expanded access program. Participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy. Participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed. Each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program. Functional assessments will be done at a minimum of every three months.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis , Lou Gehrig Disease , Familial Amyotrophic Lateral Sclerosis , Motor Neuron Disease , Motor Neuron Disease, Familial
Study Type:
Interventional
Type of Intervention:
Behavioral
Intervention Name:
Rehabilitation
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Washington University School of Medicine
Estimated Enrollment:
10
Estimated Study Start Date:
11 / 08 / 2022
Estimated Study Completion Date:
12 / 01 / 2024
Posting Last Modified Date:
02 / 13 / 2023
Date Study Added to neals.org:
02 / 13 / 2023
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:- Confirmed diagnosis of ALS with an SOD1 mutation
- Current enrollment in the tofersen expanded access program
- Age greater than 18 years
- Medically able to participate in outpatient physical therapy and/or home-based rehabilitation, as determined by the treating health care provider
Exclusion Criteria:
- Any comorbidities or conditions that, in the opinion of the treating healthcare provider, would unacceptably increase the risk of participation in outpatient physical therapy and/or home-based rehabilitation
Washington University School of Medicine
Saint Louis, Missouri
63110
United States