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The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00400127
Enrollment
6
Registered
2006-11-16
Start date
2005-09-30
Completion date
2007-04-30
Last updated
2009-06-04

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

Conditions

Amputee

Keywords

transfemoral amputee, silicon suspension, balance, gait

Brief summary

The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.

Interventions

DEVICESilesian suspension belt

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* be forty-five (45) or older; * unilateral transfemoral amputee; * current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site; * can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.); * are in the process of being fitted with a silicon suction liner and pin system; * are competent to give informed consent or have a proxy with power of attorney; * have the written permission of the attending physician to participate; * be willing to take part in the study, including signing the consent after carefully reading it.

Exclusion criteria

* have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician; * have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician; * have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.

Design outcomes

Primary

MeasureTime frame
Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire

Secondary

MeasureTime frame
demographics
prosthetic components

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026