Task Specific Training for Advanced Multiple Sclerosis

NCT ID: NCT06506929

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-10

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study- single group pretest postest
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Task specific Physical Therapy

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

Group Type EXPERIMENTAL

Task specific physical therapy

Intervention Type OTHER

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

Interventions

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Task specific physical therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Multiple Sclerosis Foundation

UNKNOWN

Sponsor Role collaborator

Hunter College of City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Herb Karpatkin

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herbert Karpatkin

Role: PRINCIPAL_INVESTIGATOR

Hunter College of City University of New York

Locations

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

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Herbert Karpatkin, DSc

Role: CONTACT

212-396-7115

Arita Winter

Role: CONTACT

212-650-3053

Facility Contacts

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Herbert Karpatkin, DSc

Role: primary

212-396-7115

Arita Winter

Role: backup

212-650-3053

References

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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.

Reference Type BACKGROUND
PMID: 32323606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22668675 (View on PubMed)

Other Identifiers

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2024-0303

Identifier Type: -

Identifier Source: org_study_id

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