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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Task Specific Physical Therapy, Task-Specific Training, Task-Oriented Physical Therapy, Rehabilitation Therapy for Advanced Multiple Sclerosis?

Research shows that task-oriented training can help improve upper limb functions in people with multiple sclerosis, although it may not be significantly more effective than conventional physical therapy. Additionally, task-specific training has been effective in improving motor skills in other conditions like stroke, suggesting potential benefits for MS patients. ^{1 2 3 4 5}

Is task-oriented physical therapy safe for people with multiple sclerosis?

The research does not specifically mention safety concerns, suggesting that task-oriented physical therapy is generally considered safe for people with multiple sclerosis. ^{1 3 6 7 8}

How is Task Specific Physical Therapy different from other treatments for advanced Multiple Sclerosis?

Task Specific Physical Therapy focuses on improving specific motor skills by practicing tasks that are directly related to daily activities, which can help enhance upper limb functions in people with Multiple Sclerosis. Unlike conventional physical therapy, it emphasizes individualized training intensity and task-oriented exercises, potentially offering a more tailored approach to rehabilitation. ^{1 3 9 10 11}

Research Team

Herbert Karpatkin

Principal Investigator

Hunter College of City University of New York

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Task-oriented training for upper limb functions in patients with multiple sclerosis: Systematic review and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The role of technology in task-oriented training in persons with subacute stroke: a randomized controlled trial. [2016]

3. Netherlands 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Combined task-specific training and strengthening effects on locomotor recovery post-stroke: a case study. [2019]

5. England 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Perspectives From Persons With Multiple Sclerosis for a Comprehensive Real-World Change Therapy for Mobility. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Role of Cognitive Impairment on Physical Therapy Attendance and Outcomes in Multiple Sclerosis. [2023]

8. Netherlands 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. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Use of physical therapy services among middle-aged and older adults with multiple sclerosis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Robot-supported upper limb training in a virtual learning environment : a pilot randomized controlled trial in persons with MS. [2018]