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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called modular powered orthoses, resembling a robotic suit for the legs. It aims to assist individuals with weak joints in improving movement, particularly during lifting or walking. Researchers aim to determine if these orthoses can enhance posture in younger individuals and simplify daily activities for older adults. Suitable candidates for this trial include young adults who can lift a 10 kg weight and seniors who can walk unassisted for six minutes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mobility for many.

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 prior data suggests that these modular powered orthoses are safe for use?

Research shows that devices like exoskeletons, which assist with movement, are generally easy for people to use. One study examined older adults using a hip exoskeleton to aid walking and found the device effective and safe. Another study focused on a muscle support system in a hip exoskeleton and demonstrated its safe use in everyday life.

While these results are encouraging, it's important to note that the current trial remains in the early stages. Detailed safety information may not yet be available. However, testing these devices in clinical settings suggests they are considered safe enough for human trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about modular powered orthoses because they offer a new way to assist individuals with frailty and sarcopenia, conditions marked by muscle weakness and loss. Unlike traditional treatments that might involve exercise programs or nutritional supplements, these powered exoskeletons provide direct, mechanical support to the body. This technology aims to enhance mobility and strength by physically supporting and augmenting the user’s movements. It represents a promising step forward by potentially improving quality of life and independence for those affected by these conditions.

What evidence suggests that these modular powered orthoses are effective for frailty/sarcopenia?

Research shows that powered braces, known as modular orthoses, can help people with weak muscles move better. In this trial, participants will use a modular powered orthosis while performing various tasks. One study found that a hip exoskeleton improved walking in older adults, potentially benefiting those with frailty or muscle loss. Another study tested a robotic exoskeleton with a special program to support muscles, which helped with movement. These findings suggest that powered orthoses might enhance posture and movement for people with weak leg muscles. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 65 and 85 years old.

I weigh less than 250 lbs.

You can lift and lower a 10 kg weight using a specific squat technique for 10 times without hurting your back.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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 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]

Citations

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In the study, a GPE-based muscle support algorithm, optimized for embedded and portable environments, is applied to a robotic hip exoskeleton ( ...

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A State-of-the-Art of Exoskeletons in Line with the WHO's ...

The study on sarcopenia by Norris et al. (2007) [49] with powered ankle–foot orthoses (PAFOs) revealed no statistically significant improvement ...