28 Participants NeededMy employer runs this trial

Walk-BEST for Osteoporosis

(Walk-BEST Trial)

VG
Overseen ByVelizara Garkova, MSc
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Must be taking: Anti-osteoporosis medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new walking program called Walk-BEST™, designed to help older adults with osteoporosis improve their walking. The goal is to determine if this program is easy to use and acceptable for this group. Participants will either start the program immediately or after a 3-month delay. It suits those aged 70 and older who can walk independently, have experienced certain types of fractures or falls, or are on specific osteoporosis medications.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance mobility and quality of life for older adults with osteoporosis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on certain osteoporosis medications, so you might not need to stop those.

What prior data suggests that the Walk-BEST™ program and Heel2Toe™ sensor are safe for older adults with osteoporosis?

Research shows that the Walk-BEST™ program, which uses the Heel2Toe sensor, helps older adults with osteoporosis walk more safely and reduce falls. Studies have found that the Heel2Toe sensor can improve walking ability. In one study, 13 out of 14 participants improved their performance in a six-minute walk test. This suggests that the treatment is generally well-tolerated and might be safe to use.

The sensor has undergone clinical validation, proving its effectiveness in promoting safer walking. No major negative side effects have been reported from the Walk-BEST program or the Heel2Toe sensor in the available studies. This supports the likelihood of its safety for participants.12345

Why are researchers excited about this trial?

Researchers are excited about Walk-BEST for osteoporosis because it introduces a novel approach to managing the condition. Unlike standard treatments that primarily focus on medication to increase bone density or slow bone loss, Walk-BEST incorporates a wearable Heel2Toe sensor to enhance walking patterns and balance. This method aims to reduce the risk of falls and fractures, which are common concerns for individuals with osteoporosis. By potentially improving mobility and safety through real-world walking interventions, Walk-BEST offers an innovative complement to existing pharmaceutical options.

What evidence suggests that the Walk-BEST™ program is effective for osteoporosis?

Research has shown that the Walk-BEST™ technology, which uses the Heel2Toe sensor, improves walking in people with osteoporosis. In one study, 13 out of 14 participants walked farther and better in a six-minute test after using the Heel2Toe sensor. This trial will evaluate the Walk-BEST™ intervention, with some participants receiving it immediately and others after a 3-month delay. The technology provides real-time sound feedback to help users adjust their steps and reduce the risk of falling. Specifically, improvements were observed in both the distance and quality of walking, which is crucial for those with balance issues. Overall, these findings suggest that Walk-BEST™ can be a valuable tool for enhancing walking and reducing fall risk in older adults with osteoporosis.12367

Who Is on the Research Team?

SM

Suzanne Morin, MD

Principal Investigator

RI-MUHC

Are You a Good Fit for This Trial?

This trial is for older adults who have osteoporosis and are able to walk. Participants should not have any conditions that would prevent them from safely joining a walking program.

Inclusion Criteria

I have had a fracture after age 40, frequent falls, low bone density, or take osteoporosis medication.
I can walk on my own, with or without a walking aid.
I am 70 years old or older.

Exclusion Criteria

I am unable to give informed consent or communicate in English or French.
I have had a bone fracture in the past year.
I cannot walk alone due to medical or cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Training

Participants receive initial assessment and begin the Walk-BEST program with remote sessions and technology phone calls over the first 4 weeks.

4 weeks
3-5 remote sessions, 2 technology phone calls

Independent Home Practice

Participants practice walking with the Heel2Toe sensor and complete exercises independently at home.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with reassessments at 3-month intervals.

6 months
3 on-site visits

What Are the Treatments Tested in This Trial?

Interventions

  • Heel2Toe™ sensor
  • Walk-BEST™

Trial Overview

The study is testing a technology-assisted walking program called Walk-BEST™, which uses the Heel2Toe™ sensor to help improve walking in people with osteoporosis. The goal is to see if this approach can reduce falls and fractures.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Walk-BEST ImmediateExperimental Treatment2 Interventions
Group II: Walk-BEST DelayedActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials
476
Recruited
170,000+

Citations

People With Osteoporosis Can Walk-BEST to Reduce Fall ...

The Walk-BEST™ technology assisted gait optimization program has demonstrated effectiveness in improving gait pattern and walking capacity ...

Discriminating Between Fallers and Non-Fallers Using ... - PMC

This is a comparative study of ankle angular velocity measures between people who have or have not experienced a fall in the past year. 2.1.

Real-Time Auditory Feedback–Induced Adaptation to ...

All gait parameters, proportion of good steps, AV, and duration of walking bouts improved. The coefficient of variation of AV decreased, ...

Real-time Auditory Feedback for Improving Gait and ...

Thirteen of 14 people in the Heel2Toe group improved over measurement error on the primary outcome, the Six Minute Walk Test, (mean change 66.4 ...

Discriminating Between Fallers and Non-Fallers Using ...

This is a comparative study of ankle AV metrics between people who have or have not experienced a fall in the past year. Data came from ...

Reduce Falls in Older Adults: The Role of Technology

Walking capacity was the primary outcome: 13 of 14 participants in the Heel2Toe group improved on the six-minute walk test, while none of seven ...

People With Osteoporosis Can Walk-BEST to Reduce Fall and ...

This study aims to help older people with osteoporosis walk better. It uses a special sensor and exercise program to reduce fall and fracture risk.