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The effect of a novel floor-based dome device on lower limb haemodynamics of seated individuals

Randomised controlled trial, of healthy 18-65 year old subjects randomised to use their left or right foot on floor-based dome device, comparing the venous haemodynamics of the dome-mobilised limb and the non-mobilised limb.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000020684
Enrollment
10
Registered
2014-01-08
Start date
2014-06-28
Completion date
2014-06-29
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Blood flow in the veins of the legs usually slows down when a person sits for a period of time. This study is designed to see if blood flow in the veins can be improved by using a small foot rest that encourages people to compress their foot on it intermittently. This may help reduice the incidence of blood clots in legs that can occur with protracted periods of sitting.

Interventions

Change in protocol re timing of measurement of blood flow by ultrasound - which is now as follows: Floor- based footrest. This is a small device, approx 300mm in length, with two raised domes. Viewed from the front it looks like the letter m. The participant flexes and extends the plantar portion of the sole of their foot over the dome to promote venous blood return through compression of the venous plexus in the sole of the foot. For this study, participants will be asked to sit on an apporpr

Change in protocol re timing of measurement of blood flow by ultrasound - which is now as follows: Floor- based footrest. This is a small device, approx 300mm in length, with two raised domes. Viewed from the front it looks like the letter m. The participant flexes and extends the plantar portion of the sole of their foot over the dome to promote venous blood return through compression of the venous plexus in the sole of the foot. For this study, participants will be asked to sit on an apporpriately adjusted chair so that their feet rest flat on the floor with their knees at 120 degrees (measured by a goniometer). They will remain in this position until time 10 minutes when basline ultrasound measures of popliteal venous flow will be done. Then at time points 14 and 18 minutes, they will be asked to flex and extend the sole of one foot (selected by pre-prepared randomisation programme) over the dome device for 60 seconds. Two ultrasound measurements at the popliteal vein will be done in the mobilising leg while it is mobilising, and two measures of popliteal flow will be done in the immobile leg immediately after. The study will be deemed to be completed after the measures that start at the 18 minute time point.

Sponsors

Victoria University of Wellington
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Able to provide informed consent Aged between 18 and 65 years

Exclusion criteria

1. History of previous or current deep vein thrombosis 2. Pregnancy (this may alter lower limb venous return from compression at the level of the iliac vein) 3. History or clinical features of peripheral vascular disease (including arterial and venous insufficiency), or other lower limb abnormalities, such as peripheral neuropathy, scleroderma, lymphoedema, or joint deformity from inflammatory arthritis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026