Clinical trial NCT06506929: Task Specific Training for Advanced Multiple Sclerosis
Official title: The Effect of Task Specific Physical Therapy for Persons With Advanced Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Foundation
First posted: 2024-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study- single group pretest postest
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). In this study 10 participants diagnosed with severe MS will engage in 1-hour physical therapy sessions twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility.

Detailed description: The purpose of this study is to investigate the feasibility, safety, and efficacy of task-specific physical therapy for persons with severe MS. The hypothesize for this study that a task-specific physical therapy program is safe, feasible, and effective in persons with severe MS.

Multiple studies have confirmed the effectiveness of task specific physical therapy for persons with MS. However,MS is a progressive disease which can lead to mild to severe disability and the studies examining the effectiveness of task specific therapy have only been conducted on persons with mild to moderate MS impairments. The small amount of research on physical therapy for persons with severe disability due to MS has only looked at the use of generalized conditioning exercises(1). Task specific therapy has been shown to be effective in persons with severe disability in non-MS neurologic disorders.(2) The effectiveness of task specific exercises on persons with severe MS not been studied. Based on the previous scientific evidence of the effectiveness of task-specific physical therapy in MS subjects with mild-to-moderate disability, there is strong scientific justification for conducting a trial of task specific therapy on persons with severe disability due to MS.

The results of this study will be presented at various conferences attended by physical therapists as well as other health care practitioners who specialize in MS care, including the American Physical Therapy Combined Sections Meeting, as well as the Consortium of Multiple Sclerosis Centers annual meeting. Additionally, upon completion of the study, we will submit a manuscript to the appropriate peer review journal.

Eligibility criteria: Inclusion Criteria:

1. definitive diagnosis of Multiple Sclerosis
2. Expanded Disability Status Scale (EDSS) of 7.0-8.0
3. Ability to read, understand , and sign an informed consent -

Exclusion Criteria:

1. evidence of MS exacerbation in the 4 weeks prior to starting the study
2. any orthopedic, cardiopulmonary, or non-MS neurologic symptoms that will interfere with their ability to participate in the study

Primary outcomes:
measure: Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)
timeFrame: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Secondary outcomes:
measure: Multiple Sclerosis Impact Scale-29 (MSIS29)
timeFrame: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College, Physical Therapy Department, City University of New York
state: New York
Study officials:
affiliation: Hunter College of City University of New York
name: Herbert Karpatkin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
citation: Arya KN, Verma R, Garg RK, Sharma VP, Agarwal M, Aggarwal GG. Meaningful task-specific training (MTST) for stroke rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2012 May-Jun;19(3):193-211. doi: 10.1310/tsr1903-193.