Supervised Walking Assistance for Limited Mobility in Older Patients

Recruiting in Cleveland (>99 mi)

+4 other 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

Trial Summary

What is the purpose of this trial?

The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.

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 data supports the effectiveness of the treatment Mobility Technician-Assisted Ambulation for improving mobility in older patients?

Research shows that using Mobility Technicians (MTs) in hospitals helps older patients move more, which can lead to better recovery and shorter hospital stays. In one study, patients who received help from MTs were more likely to go home sooner and spent less time in the hospital, saving costs and improving hospital efficiency. ^{1 2 3 4 5}

Is supervised walking assistance safe for older patients with limited mobility?

Research on devices similar to supervised walking assistance, like active assist transfer devices and robotic walkers, suggests they are generally safe. These devices have shown positive outcomes in terms of safety and satisfaction, although more rigorous studies are needed to confirm these findings. ^{6 7 8 9 10}

How is the Mobility Technician-Assisted Ambulation treatment different from other treatments for limited mobility in older patients?

The Mobility Technician-Assisted Ambulation treatment is unique because it involves a supervised walking aid that partially relieves body weight, providing stability and facilitating movement for those with severe mobility issues. Unlike traditional walkers, this treatment includes a motorized, self-propelled mechanism that helps maintain step symmetry and reduces the physical effort required from the patient. ^{11 12 13 14 15}

Research Team

Michael Rothberg, M.D.

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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 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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial. [2023]

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

Improving Discharge Rates to Home With the Help of Mobility Technicians: A Step in the Right Direction. [2023]

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

Providing Patient Mobilization With a Mobility Technician Improves Staff Efficiency and Constrains Cost in Primary Total Hip Arthroplasty. [2021]

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

BOOSTing patient mobility and function on a general medical unit by enhancing interprofessional care. [2021]

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

Mobility Technicians: A Viable Solution to Early Ambulation of Total Joint Replacement Patients. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Assistive technology training: diverse audiences and multidisciplinary content. [2019]

7. England 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. [2021]

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

Intelligent walkers for the elderly: performance and safety testing of VA-PAMAID robotic walker. [2019]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Further Development of a Robotic-Assisted Transfer Device. [2018]

11. England 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. [2018]

12. Japan pubmed.ncbi.nlm.nih.gov

A walker with a device of partial suspension for patients with gait disturbance: body weight supported walker. [2019]

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

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

14. England pubmed.ncbi.nlm.nih.gov

Self-propelled weight-relieving walker for gait rehabilitation. [2019]

15. England pubmed.ncbi.nlm.nih.gov

A review of the functionalities of smart walkers. [2015]