Task Specific Training for Advanced Multiple Sclerosis

NCT06506929 | Recruiting

• 1 other identifier: 2024-0303
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Multiple Sclerosis Impact Scale-29 (MSIS29)

  Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.

Study Arms (1)

Task specific Physical Therapy

EXPERIMENTAL

Participants will received task specific physical therapy for 1 hour, twice a week for 6 weeks

Other: Task specific physical therapy

Interventions

Task specific physical therapy OTHER

Physical Therapy based specifically on tasks that the participant os having difficulty with

Task specific Physical Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• Multiple Sclerosis Foundation: collaborator

Study Sites (1)

Hunter College, Physical Therapy Department, City University of New York

New York, New York, 10010, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 32323606 BACKGROUND

• 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.

  PMID: 22668675 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Herbert Karpatkin

  Hunter College of City University of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herbert Karpatkin, DSc

CONTACT

212-396-7115; hkarpatkin@hunter.cuny.edu

Arita Winter

CONTACT

212-650-3053; aw4338@hunter.cuny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Pilot study- single group pretest postest

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 18, 2024
• Study Start: July 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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
• Access Criteria: Access will be granted following review of the request by the PI

Locations

US (1)