Task Specific Training for Advanced Multiple Sclerosis

The Effect of Task Specific Physical Therapy for Persons With Advanced Multiple Sclerosis

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Task specific physical therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herbert Karpatkin, DSc; Phone Number: 212-396-7115; Email: hkarpatkin@hunter.cuny.edu
• Study Contact Backup: Name: Arita Winter; Phone Number: 212-650-3053; Email: aw4338@hunter.cuny.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • Hunter College, Physical Therapy Department, City University of New York
      • Contact: Herbert Karpatkin, DSc; Phone Number: 212-396-7115; Email: hkarpatk@hunter.cuny.edu
      • Contact: Arita Winter; Phone Number: 212-650-3053; Email: aw4338@hunter.cuny.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Task specific Physical Therapy; Participants will received task specific physical therapy for 1 hour, twice a week for 6 weeks	Other: Task specific physical therapy; Physical Therapy based specifically on tasks that the participant os having difficulty with

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)	Assessment of ability to perform functional mobility tasks. The MSPFFA is a 14 item ordinal scale; the maximum score is a 56, minimom score is 14. The higher the score, the better the function and the less physically frail the person being tested is considered to be.	Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple Sclerosis Impact Scale-29 (MSIS29)	Self report measure of the impact of MS on the participant. The MSIS-29 is 29 item self report measure. The higher the score, the greater the impact of MS on the person person reporting bleives they have.The score is rated from 0-100 with the higher score indicating a greater impact on the individual from MS.	Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York
• Collaborators: Multiple Sclerosis Foundation
• Investigators: Principal Investigator: Herbert Karpatkin, Hunter College of City University of New York

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2024-0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In addition to Individual Participant Data (IPD) the following information will be shared Study Protocol
• IPD Sharing Time Frame: Information to be shared will become available after publication of our findings in the appropriate peer review Journal. We expect this to happen by 12/20025 12/2025 as
• IPD Sharing Access Criteria: Access will be granted following review of the request by the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No