- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400127
The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
June 3, 2009 updated by: Nova Scotia Health Authority
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 4K4
- Nova Scotia Rehabilitation Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: amputee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Quiet standing balance
|
Timed-up and Go
|
ambulation profile
|
questionnaire
|
Secondary Outcome Measures
Outcome Measure |
---|
demographics
|
prosthetic components
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Adderson, Capital Health, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
November 15, 2006
First Submitted That Met QC Criteria
November 15, 2006
First Posted (Estimate)
November 16, 2006
Study Record Updates
Last Update Posted (Estimate)
June 4, 2009
Last Update Submitted That Met QC Criteria
June 3, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- CDHA015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amputee
-
University of OttawaCompleted
-
Sheba Medical CenterCompletedUnilateral Transtibial Amputee
-
University of WashingtonCompletedTranstibial AmputeeUnited States
-
Eastern Mediterranean UniversityCompleted
-
Encore Medical, L.P.VA Salt Lake City Health Care SystemUnknownTraumatic AmputeeUnited States
-
Marmara UniversityUnknownTranstibial Amputee | Loading | Conventional | 3DTurkey
-
VA Office of Research and DevelopmentDefense Advanced Research Projects AgencyRecruitingUpper Extremity AmputeeUnited States
-
Marmara UniversityCompleted
-
VA Office of Research and DevelopmentRecruitingDiabetic Peripheral Neuropathy | Lower Extremity AmputeeUnited States
Clinical Trials on Silesian suspension belt
-
Mayo ClinicCompletedDizziness ChronicUnited States
-
Brigham and Women's HospitalEndo Tools Therapeutics S.A.Not yet recruitingObesity | Obesity, Morbid | Weight, Body | Metabolic DiseaseUnited States
-
Sunnybrook Health Sciences CentreCompletedRotator Cuff Impingement SyndromeCanada
-
University of CalgaryCompletedPelvic Girdle Pain
-
Sunnybrook Health Sciences CentreTerminatedObstructive Sleep Apnea | Stroke, IschemicCanada
-
University of PittsburghNational Institute of Neurological Disorders and Stroke (NINDS); National Institute... and other collaboratorsRecruitingCommunity Mobility of Older Adults | Locomotor Adaptability | Gait AutomaticityUnited States
-
Theranova, L.L.C.University of NebraskaCompletedOsteopeniaUnited States
-
Muğla Sıtkı Koçman UniversityBezmialem Vakif UniversityRecruiting
-
ThuasneRecruiting
-
Pugazhendhi VijayaramanMedtronicCompleted