Powered Orthoses for Frailty/Sarcopenia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Disqualifiers: Neuromuscular, Musculoskeletal, Cardiovascular, Cognitive, others

No Placebo Group

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.

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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.

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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.

Trial 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

Participant Groups

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.

Group I: Exoskeleton Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rehab Lab, University of Michigan Ann Arbor, MI

Who Is Running the Clinical Trial?

University of Michigan Lead Sponsor

National Institute for Biomedical Imaging and Bioengineering (NIBIB) Collaborator

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] To establish whether existing exercise programmes offered to people with sarcopenia or frailty adhere to the current evidence base.

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] To investigate the relationship between frailty and sarcopenia, by evaluating the prevalence of sarcopenia among frail, pre-frail and robust elderly nursing home residents in Belgium.

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

E-Health Interventions for Older Adults With Frailty: A Systematic Review. [2023] : To systematically review the efficacy of e-Health interventions on physical performance, activity and quality of life in older adults with sarcopenia or frailty.

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

Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project). [2023] To determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia.

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] To investigate the coexistence of sarcopenia, frailty, undernutrition and obesity and to identify the factors associated with the cooccurrence of these conditions in an older population.

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] To investigate the feasibility and benefits of whole-body vibration (WBV) exercise as a safe and effective training tool for countering sarcopenia and age-related declines in mobility and function in the frail elderly.