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The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

N

Nova Scotia Health Authority (NSHA)

Status

Terminated

Conditions

Amputee

Treatments

Device: Silesian suspension belt

Study type

Interventional

Funder types

Other

Identifiers

NCT00400127
CDHA015

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

6 participants in 1 patient group

amputee
Experimental group
Treatment:
Device: Silesian suspension belt

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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