Powered Orthoses for Frailty/Sarcopenia

Overseen By Emily Klinkman, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Neuromuscular, Musculoskeletal, Cardiovascular, Cognitive, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

33 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal of this project is to develop modular, lower-limb, powered orthoses that fit to user-specific weakened joints and control force/torque in a manner that enhances voluntary motion in broad patient populations. This project aims to establish feasibility of assisting different populations with these modular powered orthoses. The investigators hypothesize that assisting lower-limb musculature with modular powered orthoses will improve 1) lifting/lowering posture in able-bodied subjects and 2) functional outcomes in elderly subjects.

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Modular Powered Orthoses for frailty or sarcopenia?

The research does not directly address the effectiveness of Modular Powered Orthoses, but studies show that interventions combining physical activity and technological support can help prevent mobility issues in older adults with frailty or sarcopenia. ^{1 2 3 4 5}

How is the treatment Modular Powered Orthoses different from other treatments for frailty or sarcopenia?

Modular Powered Orthoses are unique because they are wearable devices that assist with movement, providing physical support and enhancing mobility for individuals with frailty or sarcopenia. Unlike traditional treatments that may focus on exercise or nutrition, these orthoses directly aid in physical activity, potentially improving strength and function without the need for medication or intensive physical training. ^{1 2 3 5 6}

Eligibility Criteria

This trial is for adults under 250 lbs who can lift a weight using a specific technique or walk unassisted. It's for those aged 18-65 able to perform certain lifts and those 65-85 who can walk for six minutes. Excluded are individuals with significant pain, cognitive deficits, allergies to medical tape, recent fractures, major health conditions that affect walking, or advised against exercise by doctors.

Inclusion Criteria

I am between 18 and 65 years old.

I am between 65 and 85 years old.

I weigh less than 250 lbs.

Exclusion Criteria

I have severe joint pain that makes it hard for me to walk.

Pregnant (self-report)

I have a history of chronic lower-back pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform various tasks while wearing the modular powered orthosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Modular Powered Orthoses

Trial Overview The study tests lower-limb powered orthoses designed to assist weakened joints and enhance voluntary motion in various populations. The goal is to see if these devices improve posture during lifting tasks in able-bodied subjects and functional outcomes in the elderly.

Participant Groups

Group I: Exoskeleton Experimental Treatment 1 Intervention

Participants in this arm of the study will perform various tasks while wearing the modular powered orthosis

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Findings from Research

A national survey of 136 practitioners in the UK revealed that while 94% provide exercise programs for older adults with sarcopenia or frailty, most programs focus on fall prevention rather than resistance training, which is crucial for improving muscle strength.

Only 9% of programs emphasized resistance training, and 65% offered exercise once a week or less, indicating a lack of adherence to evidence-based practices that could effectively enhance outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content of exercise programmes targeting older people with sarcopenia or frailty - findings from a UK survey. Witham, MD., Chawner, M., Biase, S., et al.[2022]

In a study of 662 elderly nursing home residents in Belgium, 38.1% were found to have sarcopenia, with nearly 50% of frail individuals diagnosed with this condition.

The research indicates a strong link between frailty and sarcopenia, as 47% of frail residents were sarcopenic, highlighting the need for targeted interventions in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of sarcopenia in a population of nursing home residents according to their frailty status: results of the SENIOR cohort. Buckinx, F., Reginster, JY., Brunois, T., et al.[2018]

A systematic review of 4 studies involving older adults with frailty found that e-Health interventions can lead to significant improvements in muscle strength, with a standardized mean difference of 0.51, indicating a moderate effect.

Despite the positive effects observed, the review concluded that there is insufficient overall evidence to fully support the efficacy of e-Health interventions for improving physical performance and quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-Health Interventions for Older Adults With Frailty: A Systematic Review. Han, HW., Park, SW., Kim, DY., et al.[2023]

A multicomponent intervention combining physical activity and nutritional counseling significantly reduced the incidence of mobility disability in older adults with physical frailty and sarcopenia, with a hazard ratio of 0.78, indicating a 22% lower risk compared to controls.

Participants in the intervention group showed better improvements in physical performance and less decline in muscle strength and lean mass over 36 months, suggesting that targeted interventions can effectively preserve mobility in vulnerable older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project). Bernabei, R., Landi, F., Calvani, R., et al.[2023]

In a study of 1454 older adults in Portugal, 57.3% were found to have at least one condition related to nutritional status, such as sarcopenia, frailty, undernutrition, or obesity, highlighting the prevalence of these issues in the elderly population.

Factors such as being male, married, and having a higher education level were associated with a lower likelihood of having multiple conditions, while older age, poor self-perception of health, taking five or more medications, and cognitive impairment were linked to a higher risk of coexisting conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sarcopenia, physical frailty, undernutrition and obesity cooccurrence among Portuguese community-dwelling older adults: results from Nutrition UP 65 cross-sectional study. Sousa-Santos, AR., Afonso, C., Borges, N., et al.[2021]

A study involving 117 frail elderly participants showed that 16 weeks of whole-body vibration (WBV) exercise significantly improved mobility and function, with benefits lasting up to 12 months after the intervention.

WBV exercise was safe and well-tolerated, with high compliance rates (93%), and it outperformed control and simulated WBV groups in functional tests, demonstrating its effectiveness as a training tool against age-related declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial. Wadsworth, D., Lark, S.[2020]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Content of exercise programmes targeting older people with sarcopenia or frailty - findings from a UK survey. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Prevalence of sarcopenia in a population of nursing home residents according to their frailty status: results of the SENIOR cohort. [2018]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

E-Health Interventions for Older Adults With Frailty: A Systematic Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Sarcopenia, physical frailty, undernutrition and obesity cooccurrence among Portuguese community-dwelling older adults: results from Nutrition UP 65 cross-sectional study. [2021]

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

Effects of Whole-Body Vibration Training on the Physical Function of the Frail Elderly: An Open, Randomized Controlled Trial. [2020]