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NCT Number: NCT06506929

Task Specific Training for 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Task specific physical therapy

Other

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

Primary outcomes

  1. Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)

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

    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.

Secondary outcomes

  1. Multiple Sclerosis Impact Scale-29 (MSIS29)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arita Winter

CONTACT

[email protected]

212-650-3053

Herbert Karpatkin, DSc

CONTACT

[email protected]

212-396-7115

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • Multiple Sclerosis Foundation

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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