Physical Therapy for Advanced Multiple Sclerosis

Overseen By Herbert Karpatkin, DSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hunter College of City University of New York

Disqualifiers: Orthopedic, cardiopulmonary, non-MS neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify effective physical therapy treatments for individuals with severe multiple sclerosis, a condition in which the immune system attacks the nervous system, causing serious mobility issues. Participants will engage in task-specific physical therapy, focusing on improving standing, balancing, and moving in bed. Suitable candidates should have a diagnosis of severe MS and experience significant challenges in daily physical activities. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance daily life for those with severe MS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this physical therapy is safe for individuals with severe multiple sclerosis?

Research has shown that task-specific physical therapy is generally safe for people with multiple sclerosis (MS). Studies have found that task-oriented circuit training, a similar approach, is both safe and feasible for those with MS. For instance, one study discovered that a high-intensity task-oriented training program was well-tolerated by participants, indicating that these exercises can be done without major risk. While this specific study examines physical therapy for severe MS, existing research supports the safety of similar treatments for MS overall. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for advanced multiple sclerosis, which often includes medications like interferons or monoclonal antibodies, the task-specific physical therapy being explored is all about honing in on real-world tasks to improve daily function. This approach tailors exercises to the individual, focusing on the specific movements and tasks they need in their daily lives. Researchers are excited because this personalized method could lead to more meaningful improvements in mobility and independence, offering a fresh perspective beyond traditional medication-based treatments.

What evidence suggests that task-specific physical therapy is effective for severe multiple sclerosis?

Research has shown that exercise is one of the best non-drug treatments for multiple sclerosis (MS). In this trial, participants will receive task-specific physical therapy, which involves practicing everyday activities and has shown promise in improving balance for people with MS. Studies have found that these exercises can aid with mobility and balance, common issues for those with severe MS. Effective rehabilitation often combines therapies like physiotherapy and occupational therapy to assist with daily activities. Evidence suggests that targeted physical therapy can help manage symptoms and improve the quality of life for people with severe MS. ^{3 4 6 7 8}

Who Is on the Research Team?

Herbert Karpatkin

Principal Investigator

Hunter College of City University of New York

Are You a Good Fit for This Trial?

This trial is for individuals with severe multiple sclerosis. Participants should be able to commit to twice-weekly physical therapy sessions over a period of 6 weeks, focusing on improving standing, balancing, and bed mobility.

Inclusion Criteria

I need help walking but can do some tasks myself.

Ability to read, understand, and sign an informed consent

I have been officially diagnosed with Multiple Sclerosis.

Exclusion Criteria

I have had a worsening of my MS symptoms in the last 4 weeks.

I don't have any heart, lung, bone, or non-MS nerve issues that would stop me from joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive task-specific physical therapy for 1 hour, twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Task Specific Physical Therapy

Trial Overview

The study is testing the effectiveness of task-specific physical therapy in patients with advanced MS. It involves ten participants undergoing one-hour sessions twice a week for six weeks.

How Is the Trial Designed?

Group I: Task specific Physical Therapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Hunter College of City University of New York

Lead Sponsor

Trials

43

Recruited

10,000+

Multiple Sclerosis Foundation

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Cognitive impairments in persons with multiple sclerosis (PwMS) can negatively impact their attendance at physical therapy sessions and their ability to meet rehabilitation goals, particularly due to difficulties in learning new information and reduced working memory.

Despite these cognitive challenges, a significant majority (85.2%) of PwMS showed improvements in at least one functional outcome measure after physical therapy, indicating that they can still achieve motor gains even with cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Cognitive Impairment on Physical Therapy Attendance and Outcomes in Multiple Sclerosis. Gomes, KE., Ruiz, JA., Raskin, SA., et al.[2023]

In a study of 63 individuals with subacute stroke, both groups receiving task-oriented physical therapy showed significant improvements in gait speed and other clinical measures after 2 months, with benefits maintained at a 3-month follow-up.

The use of rehabilitation technology did not provide additional benefits for locomotor recovery, indicating that the effectiveness of task-oriented therapy is independent of the technology used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial. Richards, CL., Malouin, F., Bravo, G., et al.[2016]

A survey of 500 adults with multiple sclerosis revealed that 90% of respondents were interested in participating in a novel physical therapy program called lower extremity constraint-induced therapy (LE CIT), indicating strong acceptability of the treatment.

The majority of participants (median=88%) expressed a positive attitude towards key procedures of LE CIT, especially those who had prior experience with physical therapy, suggesting that this program could effectively enhance mobility and community use of lower extremities for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives From Persons With Multiple Sclerosis for a Comprehensive Real-World Change Therapy for Mobility. Mark, VW., Lee, RD., Taub, E., et al.[2022]

A 38-year-old female stroke survivor showed significant improvements in walking speed and distance after a 6-week therapy program that combined task-specific and strength training, with an 18% increase in free walking speed and a 14.4% increase in fast walking speed post-treatment.

Gait analysis indicated that these improvements were linked to enhanced activation of key leg muscles, particularly the gluteus maximus and gluteus medius, suggesting that strengthening these muscles can positively impact functional recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined task-specific training and strengthening effects on locomotor recovery post-stroke: a case study. Sullivan, K., Klassen, T., Mulroy, S.[2019]

The case study highlights the importance of addressing psychosocial support alongside physical therapy for individuals with chronic conditions like multiple sclerosis, as this can significantly impact their ability to reintegrate into the community.

The focus on developing independent exercise habits is crucial for long-term management of multiple sclerosis, suggesting that physical therapy should not only aim to restore physical function but also promote sustainable lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring barriers to remaining physically active: a case report of a person with multiple sclerosis. Zalewski, K.[2019]

A study involving 20 people with Multiple Sclerosis showed that task-oriented upper limb training at individualized intensities led to significant improvements in upper limb function, particularly at the highest intensity (100% of individual max repetitions).

Participants experienced no adverse effects from the training, indicating that task-oriented training is safe and effective for enhancing functional recovery in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-dependent clinical effects of an individualized technology-supported task-oriented upper limb training program in Multiple Sclerosis: A pilot randomized controlled trial. Lamers, I., Raats, J., Spaas, J., et al.[2020]

Task-oriented training (TOT) has been evaluated for its effectiveness in improving upper limb functions in patients with multiple sclerosis (MS), with a review of five randomized controlled trials involving 147 patients, primarily women with an average age of 47.

While TOT alone showed potential for improving upper limb functions, meta-analyses indicated no significant differences when compared to conventional physical therapy, suggesting that while TOT can be beneficial, it may not be superior to existing treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Task-oriented training for upper limb functions in patients with multiple sclerosis: Systematic review and meta-analysis. Ahmed Hassanin, M., Aly, MG., Atef, H., et al.[2023]

In a pilot study involving 17 individuals with advanced multiple sclerosis, robot-supported upper limb training showed potential for improving movement efficiency, as participants completed tasks more quickly and effectively in a virtual environment.

Despite these improvements in movement execution, standard clinical measures did not show significant changes, suggesting that individuals with more severe upper limb dysfunction may benefit the most from this type of training, warranting further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS. Feys, P., Coninx, K., Kerkhofs, L., et al.[2018]

In a study involving 269 outpatients with multiple sclerosis across 13 centers, client-centred occupational therapy did not show significant improvements in primary outcomes like disability and participation compared to usual care OT.

While client-centred therapy was favored in terms of process outcomes, it resulted in small negative effects on secondary outcomes such as fatigue and health-related quality of life, suggesting a need to reevaluate its application in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cluster randomised controlled trial on the efficacy of client-centred occupational therapy in multiple sclerosis: good process, poor outcome. Eyssen, IC., Steultjens, MP., de Groot, V., et al.[2019]

In a study of 1,065 adults with multiple sclerosis aged 45 to 90, 36% reported never using physical therapy services, highlighting a significant gap in service utilization among this population.

Factors influencing the use of physical therapy included living in urban areas, worsening MS symptoms, mobility issues, and recent hospitalizations, indicating that access and health status are critical in determining the need for these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of physical therapy services among middle-aged and older adults with multiple sclerosis. Finlayson, M., Plow, M., Cho, C.[2022]

A retrospective review of 500 medical records from MS patients showed that physical therapy significantly improved fatigue and mobility in ambulatory patients, as measured by the Modified Fatigue Impact Scale (MFIS) and Ambulation Index (AI).

The study found that the MFIS is a reliable outcome measure for assessing treatment efficacy in ambulatory MS patients, but neither the MFIS nor the AI were effective in measuring outcomes for non-ambulatory patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of physical therapy in multiple sclerosis as measured with the modified fatigue impact scale and ambulation index: a retrospective study. Brichetto, G., Rinaldi, S., Spallarossa, P., et al.[2019]

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