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People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)

29 maj 2026 uppdaterad av: Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

28

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada, H4A 3S5
        • Rekrytering
        • Research Institute of the McGill University Health Centre
        • Kontakt:
          • Telefonnummer: 5149341934
        • Huvudutredare:
          • Suzanne Morin, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • men and women 70 years and older
  • able to walk independently with or without a walking aid
  • experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score < -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)

Exclusion Criteria:

  • fracture sustained in the past 12 months
  • unable to walk unsupervised because of active medical or neurocognitive reasons
  • unable to provide informed consent, or cannot communicate in English or French

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
Enhet: Device: Heel2Toe[TM] sensor
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.
Beteende: Technology-assisted therapeutic walking program
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.
Andra namn:
  • Walk BEST
Aktiv komparator: Walk-BEST Delayed
Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.
Enhet: Device: Heel2Toe[TM] sensor
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.
Beteende: Technology-assisted therapeutic walking program
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.
Andra namn:
  • Walk BEST

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Study recruitment rates (feasibility objective)
Tidsram: 3 months
The study will be considered feasible if the investigator can recruit 28 participants
3 months
Study retention rates (feasibility objective)
Tidsram: 9 months
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
9 months
Adherence to intervention (feasibility objective)
Tidsram: 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.
9 months
Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
Tidsram: 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.
9 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional walking capacity
Tidsram: Change from Baseline to 3 months, 6 months
Six Minute Walk Test (6MWT)
Change from Baseline to 3 months, 6 months
Grip strength
Tidsram: Change from Baseline to 3 months, 6 months
Hand Dynamometer
Change from Baseline to 3 months, 6 months
Balance
Tidsram: Change from Baseline to 3 months, 6 months
Mini-Best Test (0-28; higher is better)
Change from Baseline to 3 months, 6 months
Functional leg muscle strength
Tidsram: Change from Baseline to 3 months, 6 months
30-second Chair stand test
Change from Baseline to 3 months, 6 months
Fear of falling
Tidsram: Change from Baseline to 3 months, 6 months
6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)
Change from Baseline to 3 months, 6 months
Physical activity
Tidsram: Change from Baseline to 3 months, 6 months
Physical Activity Scale for the elderly (0-400+; higher is better)
Change from Baseline to 3 months, 6 months
Lower limb function
Tidsram: Change from Baseline to 3 months, 6 months
Lower Extremity Functional Scale (0-80; higher is better)
Change from Baseline to 3 months, 6 months
Quality of Life
Tidsram: Change from Baseline to 3 months, 6 months
Older Persons Active Living Related Quality of Life (8-32, higher is better)
Change from Baseline to 3 months, 6 months
Falls
Tidsram: Change from Baseline to 3 months, 6 months
Number of falls reported in the falls calendar
Change from Baseline to 3 months, 6 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
Tidsram: Change from Baseline to 3 months, 6 months
Degrees per second
Change from Baseline to 3 months, 6 months
Co-efficient of variation of angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
Tidsram: Change from Baseline to 3 months, 6 months
Degrees per second
Change from Baseline to 3 months, 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Utredare

  • Huvudutredare: Suzanne Morin, MD, RI-MUHC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 maj 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

25 maj 2026

Först inskickad som uppfyllde QC-kriterierna

29 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-12401

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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