Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3S5, Canada
Location status: Recruiting
NCT Number: NCT07621679
The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H4A 3S5, Canada
Location status: Recruiting
The Walk-BEST™ technology assisted gait optimization program has demonstrated effectiveness in improving gait pattern and walking capacity without adverse events in people living with Parkinson's and Multiple Sclerosis. What is not known and the topic of this pilot and feasibility study is whether older people with osteoporosis will engage successfully with this program, since they do not have a diagnosis of a disabling condition affecting gait and may be unaware that their cautious method of walking exposes them to higher risk of falls and fractures rather than protecting them.
A randomized pilot and feasibility study (PAFS) will be conducted with groups randomized in a 1:1 ratio. Participants will be randomly assigned to either 1) immediate receipt of the Walk-BEST™ program; or 2) wait-list control and delayed receipt of Walk-BEST™ program 3 months post-randomization.
Participants will receive a copy of a proprietary workbook with instructions on simple exercises targeting strength, flexibility, and balance to facilitate a better walking pattern, as well as both 3-5 remote sessions with an exercise professional to practice walking well and to learn how to use the Heel2ToeTM sensor, and two technology phone calls with a research team member, over the first 4 weeks of the intervention. This personal gait training period will be followed by independent home practice over 2 months, during which participants will be instructed to practice walking with the sensor for a minimum period of 6 min, twice a day and to complete three exercises from their workbook at least twice a week.
There will be three on-site study visits at 3-month intervals: one for initial assessment, and two for reassessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors. It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice.
Other names: Walk BEST
Time frame: 3 months
The study will be considered feasible if the investigator can recruit 28 participants
Time frame: 9 months
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
Time frame: 9 months
The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up.
Time frame: 9 months
The acceptability outcomes will be based on an exit debriefing questionnaire. Usability of the Heel2Toe sensor will be quantified with items from the Digital Health Devices Usability Indicators.
Time frame: Change from Baseline to 3 months, 6 months
Six Minute Walk Test (6MWT)
Time frame: Change from Baseline to 3 months, 6 months
Hand Dynamometer
Time frame: Change from Baseline to 3 months, 6 months
Mini-Best Test (0-28; higher is better)
Time frame: Change from Baseline to 3 months, 6 months
30-second Chair stand test
Time frame: Change from Baseline to 3 months, 6 months
6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)
Time frame: Change from Baseline to 3 months, 6 months
Physical Activity Scale for the elderly (0-400+; higher is better)
Time frame: Change from Baseline to 3 months, 6 months
Lower Extremity Functional Scale (0-80; higher is better)
Time frame: Change from Baseline to 3 months, 6 months
Older Persons Active Living Related Quality of Life (8-32, higher is better)
Time frame: Change from Baseline to 3 months, 6 months
Number of falls reported in the falls calendar
Time frame: Change from Baseline to 3 months, 6 months
Degrees per second
Time frame: Change from Baseline to 3 months, 6 months
Degrees per second
Contact information is provided by the study sponsor or research team.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Acronym: Walk-BEST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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