The Effects of Rehabilitation on Functional Outcomes in Patients With SOD1 ALS Treated With Tofersen

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:

NCT05725759

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