Physical Therapy for Multiple Sclerosis

(PromPT-MS Trial)

Overseen By Dominique Kinnett-Hopkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Physical activity and exercise help manage symptoms like fatigue in people living with multiple sclerosis (MS). Despite research supporting physical activity participation, people with MS are often insufficiently active to reach health benefits. Promotional efforts that are sustainable within the United States healthcare system are needed. This project is a pilot randomized controlled trial examining the feasibility of a consultative physical therapy intervention for increasing physical activity engagement.

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 seems focused on physical therapy and exercise, so it's best to discuss your medications with the study team.

What data supports the effectiveness of the treatment PromPT-MS for Multiple Sclerosis?

Research shows that physical therapy, including telerehabilitation, can improve gait and balance in people with Multiple Sclerosis, and is as effective as in-person therapy. This suggests that similar physical therapy programs like PromPT-MS could also be beneficial. ^{1 2 3 4 5}

Is physical therapy safe for people with multiple sclerosis?

The studies reviewed indicate that physical therapy, including telerehabilitation and home-based exercise programs, is generally safe for people with multiple sclerosis, with no significant safety concerns reported. ^{1 3 4 6 7}

How is the PromPT-MS treatment different from other treatments for multiple sclerosis?

PromPT-MS is unique because it focuses on a novel physical therapy program called lower extremity constraint-induced therapy (LE CIT), which aims to transfer improvements from the clinic to real-world use of the legs. It includes behavior change techniques like prescribed home exercises, daily therapist interviews, and activity diaries, making it distinct from other treatments that may not emphasize real-world application and structured behavior change. ^{2 3 5 8 9}

Research Team

Dominique Kinnett-Hopkins, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with Multiple Sclerosis who are not currently very active. The goal is to see if a special physical therapy program can help them exercise more.

Inclusion Criteria

Access to a smartphone

Not sufficiently active as measured by the Godin Leisure Time Exercise Questionnaire score <24

Less than 2 affirmative on the physical activity readiness questionnaire

Exclusion Criteria

Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)

Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol.

I cannot attend the study visits.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 24-week progressive exercise intervention supported by physical therapy visits and educational material

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for sustained treatment effects and complete assessments at 10 months

4 months

Treatment Details

Interventions

• PromPT-MS

Trial Overview The study tests 'PromPT-MS', a consultative physical therapy intervention designed to encourage people with MS to engage in more physical activity and manage symptoms like fatigue.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.

Group II: Waitlist Control Active Control 1 Intervention

24-week waitlist control condition

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A study involving 30 participants with Multiple Sclerosis showed that a telerehabilitation (TR) program is a feasible alternative to conventional physical therapy, lasting 8 weeks and conducted via real-time telecommunication.

The TR program demonstrated comparable efficacy to in-person physical therapy, as both methods led to improvements in gait and balance without significant differences in patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation in Multiple Sclerosis: Results of a Randomized Feasibility and Efficacy Pilot Study. Fjeldstad-Pardo, C., Thiessen, A., Pardo, G.[2020]

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 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]

A systematic review of 8 randomized clinical trials involving 919 individuals with multiple sclerosis found no significant differences in step count or moderate to vigorous physical activity levels between those who participated in physical activity interventions and those who did not.

Despite the interventions, the results indicated that physical activity did not lead to measurable improvements in physical activity intensity or step count, suggesting a need for more studies with objective measures to assess the effectiveness of exercise in individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise and physical activity-interventions on step count and intensity level in individuals with multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. Arntzen, EC., Bidhendi-Yarandi, R., Sivertsen, M., et al.[2023]

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]

References

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

Telerehabilitation in Multiple Sclerosis: Results of a Randomized Feasibility and Efficacy Pilot Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Patient-reported questionnaires in MS rehabilitation: responsiveness and minimal important difference of the multiple sclerosis questionnaire for physiotherapists (MSQPT). [2019]

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

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

4. 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]

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

Physiotherapy Rehabilitation for People With Progressive Multiple Sclerosis: A Systematic Review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The effect of exercise and physical activity-interventions on step count and intensity level in individuals with multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Self-directed exercise in multiple sclerosis: Evaluation of a home automated tele-management system. [2020]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Content and Delivery of Physical Therapy in Multiple Sclerosis across Europe: A Survey. [2020]