Supervised Walking Assistance for Limited Mobility in Older Patients

Recruiting at 4 trial locations

Overseen By Michael Rothberg, M.D.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Unstable angina, Skilled nursing, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobility technician (a professional who assists with walking) helping patients walk around the hospital up to three times a day can improve recovery. It compares this new approach to usual care, examining recovery outcomes and costs. The trial aims to determine if this extra help benefits patients and reduces overall care expenses. Patients who might be a good fit have been admitted to the hospital with limited mobility and have traditional Medicare coverage. As an unphased trial, this study offers patients the chance to contribute to innovative care practices that could enhance recovery and lower healthcare costs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this supervised walking assistance is safe for older patients?

Research has shown that having a trained person assist older patients with walking in hospitals is generally safe. Studies have found that this support can improve patients' mobility and reduce unwanted side effects. Previous research focused on how this assistance helps older patients feel better and move more without causing harm. The goal is to ensure patients can safely increase their activity, aiding faster recovery. Safety remains a key focus, and results so far are promising, indicating that this approach is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Mobility Technician" approach because it offers a hands-on, personalized method to improve mobility in older patients with limited movement. Unlike traditional physical therapy, which often requires scheduled sessions and may not be available daily, mobility technicians provide up to three daily walking sessions directly in the hospital setting, ensuring consistent and frequent activity. This approach is tailored to the patient's current mobility level, assessed using a "6-clicks score," allowing for a customized experience that can adapt quickly to changing patient needs. By integrating this consistent, patient-centered support, researchers hope to enhance recovery and prevent the decline in mobility often seen in hospitalized older adults.

What evidence suggests that supervised walking assistance is effective for limited mobility in older patients?

This trial will compare usual care with the assistance of mobility technicians (MTs) for older patients with limited mobility. Research has shown that MTs helping older adults walk in the hospital can lead to better health outcomes. Walking early during a hospital stay links to improved health and fewer complications. Studies indicate that patients who walk regularly with assistance often move better and are more likely to return home rather than go to other care facilities. A dedicated mobility technician can greatly enhance these results. Overall, using MTs to assist with walking can boost recovery and improve the hospital experience for older patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Rothberg, M.D.

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older who are admitted to a medical service, have completed necessary health checks, and have a certain level of mobility. They must be insured with Traditional Medicare or Medicare Advantage. It's not for those with significant language barriers (except Spanish at Baystate), planned discharges, upcoming surgeries, severe heart conditions, long-term nursing home residents, on comfort care only, admitted over 48 hours ago, or with active infections requiring isolation.

Inclusion Criteria

I am covered by Traditional Medicare or Medicare Advantage.

I am currently admitted to a hospital.

My mobility score is between 16 and 22.

Exclusion Criteria

I currently have an infection that requires isolation.

I cannot participate in exercise due to my unstable angina or other medical conditions.

Order for bedrest

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive supervised ambulation up to 3 times daily with a Mobility Technician (MT) until discharge or a maximum of 10 days

Up to 10 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of falls, physical function, and activities of daily living

30 days

Extended Follow-up

Assessment of total episode cost and frailty, including non-medication costs for 6 months post-enrollment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mobility technician

Trial Overview The study tests if having a Mobility Technician help patients walk up to three times daily improves health outcomes compared to usual hospital care. The focus is on the benefits and costs during the hospital stay and the first month after joining the study.

How Is the Trial Designed?

Group I: Mobility Technician Experimental Treatment 1 Intervention

Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session

Group II: Usual Care Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A new scale was developed to measure the impact of assistive technologies on the quality of life for older adults, focusing on improvements in safety, control, and participation, based on a cross-sectional survey.

The study found that assistive technology is particularly beneficial for older individuals with greater functional limitations, suggesting that these devices can help maintain independence and enhance quality of life in aging populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality-of-life scale for assistive technology: results of a pilot study of aging and technology. Agree, EM., Freedman, VA.[2021]

The study surveyed 55 assistive technology training programs across 27 states, revealing that most programs are university-based and primarily train graduate students through comprehensive courses, while community-based programs focus on shorter workshops.

Despite the growth in diverse audiences for assistive technology training, challenges such as funding instability and the need for hands-on learning experiences were highlighted by instructors and training directors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive technology training: diverse audiences and multidisciplinary content. Jans, LH., Scherer, MJ.[2019]

Only a small percentage of frail elderly individuals (3.5% using rollators and 4.3% using shopping carts) utilized these mobility aids, indicating a potential gap in the adoption of assistive devices among this population.

Satisfaction scores from the QUEST 2.0 survey showed that users of rollators reported better support in terms of repairs and services compared to shopping cart users, highlighting the need for improved follow-up and tailored walking aids for those with lower care levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actual use of and satisfaction associated with rollators and "shopping carts" among frail elderly Japanese people using day-service facilities. Kitajima, E., Moriuchi, T., Iso, N., et al.[2018]

Assistive technology users and service professionals identified key barriers in the assistive technology service delivery process, including the need for detailed selection criteria and standardized evaluation tools to improve assessments.

To enhance the delivery of assistive technology, participants emphasized the importance of government support, adequate funding, and the establishment of dedicated assistive technology centers to streamline the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators of assistive technology service delivery process (AT-SDP) in South Korea. Woo, J., Jang, W.[2023]

The introduction of mobility technicians (MTs) in a hospital setting significantly improved patient outcomes, with 79.7% of patients in the MT group discharged home compared to 66.1% in the control group, indicating enhanced recovery and mobility support.

Patients receiving MT services experienced a 2.4-day reduction in hospital stay and an estimated cost savings of $148,500 over six months, demonstrating the financial and operational benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Discharge Rates to Home With the Help of Mobility Technicians: A Step in the Right Direction. Patel, SV., Imburgio, S., Johal, AS., et al.[2023]

In a quality improvement project involving hospitalized patients, the addition of a physical therapist and mobility technician led to significant improvements in patients' functional status and mobility levels during their stay.

Although there were no significant changes in overall hospital length of stay or readmission rates, the results suggest that mobility interventions can enhance patient care quality and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BOOSTing patient mobility and function on a general medical unit by enhancing interprofessional care. Johnson, AM., Kuperstein, J., Graham, RH., et al.[2021]

The Mobility Technician (MT) program significantly improved early ambulation outcomes for 11,777 patients undergoing total joint replacement, increasing the number of ambulations and distance ambulated on the day of surgery (POD0).

After implementing the MT program, the time to first ambulation decreased, indicating that specially trained aides can effectively support early mobility, potentially enhancing recovery and reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobility Technicians: A Viable Solution to Early Ambulation of Total Joint Replacement Patients. Lisevick, AB., Kelly, S., Cremins, MS., et al.[2021]

The AMBULATE study is a large randomized controlled trial involving older medical inpatients across five hospitals, aiming to assess the impact of mobility technicians (MTs) on improving mobility and reducing adverse events during hospitalization.

The study will evaluate key outcomes such as physical performance at discharge, hospital-acquired complications, and cost-effectiveness of employing MTs, potentially providing valuable insights into enhancing care for older adults in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial. Johnson, JK., Hamilton, AC., Hu, B., et al.[2023]

The Body Weight Supported (BWS) Walker allows therapists to safely conduct gait training for patients with severe gait disturbances without additional physical strain, enabling better focus on improving balance and gait patterns.

This walker is more affordable and user-friendly compared to other body weight support systems, making it a practical option for widespread use in rehabilitation for patients with moderate to severe gait issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A walker with a device of partial suspension for patients with gait disturbance: body weight supported walker. Ochi, M., Makino, K., Wada, F., et al.[2019]

Smart walkers are being recognized as important assistive devices that can enhance mobility and support rehabilitation by providing functional compensation for users.

Research indicates that smart walkers can serve multiple roles, including acting as personal helpers for sit-to-stand movements and diagnostic tools for evaluating gait, which can improve the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the functionalities of smart walkers. Martins, M., Santos, C., Frizera, A., et al.[2015]

The Veterans Affairs Personal Adaptive Mobility Aid (VA-PAMAID) demonstrated good safety and performance, successfully traveling 10.9 km on a full charge while avoiding obstacles at speeds of up to 1.2 m/s.

Engineering tests showed that the VA-PAMAID is structurally sound and stable, with no failures during static stability or fatigue testing, although some issues were noted during obstacle climbing and sensor testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intelligent walkers for the elderly: performance and safety testing of VA-PAMAID robotic walker. Rentschler, AJ., Cooper, RA., Blasch, B., et al.[2019]

The Robotic-Assisted Transfer Device (RATD) underwent significant design improvements, including enhanced safety features like error checking and safety zones, based on feedback from focus groups of potential users, including people with disabilities and caregivers.

A majority of participants expressed willingness to use the RATD, with 63% of people with disabilities and 83% of caregivers indicating interest, suggesting a positive reception for the device's future development and potential marketability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Further Development of a Robotic-Assisted Transfer Device. Burkman, J., Grindle, G., Wang, H., et al.[2018]

The introduction of mobility technicians (MTs) in the care of patients undergoing total hip arthroplasty (THA) led to a higher percentage of patients being discharged home (91.51% vs. 87.43% in the control group), indicating improved recovery outcomes.

The use of MTs resulted in significant cost savings of approximately $119,794.50 annually for the hospital, suggesting that employing MTs can be financially beneficial while enhancing patient care during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Patient Mobilization With a Mobility Technician Improves Staff Efficiency and Constrains Cost in Primary Total Hip Arthroplasty. Mazzei, CJ., Yurek, JW., Patel, JN., et al.[2021]

The weight relieving walker (WRW) is a novel device designed to partially relieve body weight during ambulation, which helps patients with severe locomotion problems to walk more effectively.

In a study involving 26 patients, the WRW demonstrated significant benefits in facilitating walking movements and improving step symmetry, indicating its potential as an effective walking aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-propelled weight-relieving walker for gait rehabilitation. Dickstein, R., Smolinski, Z., Pillar, T.[2019]

Active assist transfer devices (AATDs) can improve safety and satisfaction for both healthcare workers and patients during transfers, but current evidence is mostly low quality and lacks controlled trials.

There is a significant need for more rigorous research on AATDs, particularly in community settings, to better understand their impact on rehabilitation outcomes and caregiver injury risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do active assist transfer devices improve transfer safety for patients and caregivers in hospital and community settings? A scoping review. Tang, K., Diaz, J., Lui, O., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10367239/

Assisted ambulation to improve health outcomes for older ... The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05725928

Study Details: Assisted Ambulation for Older Inpatients Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10696277/

Improving Discharge Rates to Home With Mobility Technicians Early ambulation during acute hospitalization has been associated with improved clinical outcomes for patients. Despite the benefits of mobility ...

4. the-hospitalist.org the-hospitalist.org/hospitalist/article/226741/mixed-topics/dedicated-mobility-technician-improves-inpatient-mobility/

A dedicated mobility technician improves inpatient mobility Studies have shown improved hospital outcomes in patients who ambulate regularly. Many assisted mobility protocols aimed at ambulating ...

5. dukespace.lib.duke.edu dukespace.lib.duke.edu/items/2b8a6f2a-6598-4a75-a7d6-96db0b15d1f7

Assisted ambulation to improve health outcomes for older ... The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients.

6. researchgate.net researchgate.net/publication/372583426_Assisted_ambulation_to_improve_health_outcomes_for_older_medical_inpatients_AMBULATE_study_protocol_for_a_randomized_controlled_trial

(PDF) Assisted ambulation to improve health outcomes for ... The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients.

7. cdn.mdedge.com cdn.mdedge.com/files/s3fs-public/issues/articles/jhm014050272.pdf

Increasing Mobility via In-hospital Ambulation Protocol ... OBJECTIVE: This study aimed to assess the feasibility and effectiveness of dedicated mobility technician-assisted ambulation in older inpatients. DESIGN: This ...

8. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-023-04285-3

Impact of an INtervention to increase MOBility in older ... This study has the potential to improve outcomes of older hospitalized patients through an intervention that should be scalable in clinical practice.