Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163787
Status:
COMPLETED
Last Update Posted:
2005-10-25
First Post:
2005-09-12
Brief Title:
Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre or the centre where they received inpatient physiotherapy services
All participants will be tested at discharge and at six months post discharge Personnel used to score and administer the balance tests at six months will be blinded to pre-test scores subject background as well as mobility and fall history in the six months post discharge
At discharge participants will perform two successful Four Square Step Tests FSST and will be videotaped performing the Timed Up and Go Test TUGT The turn measure will be scored from this TUGT Participants will also complete the Locomotor Capabilities index LCI
At the six-month test participants repeat balance and mobility tests and LCI as well as being interviewed to ascertain fall history since discharge
All participants will be tested at discharge and at six months post discharge Personnel used to score and administer the balance tests at six months will be blinded to pre-test scores subject background as well as mobility and fall history in the six months post discharge
At discharge participants will perform two successful Four Square Step Tests FSST and will be videotaped performing the Timed Up and Go Test TUGT The turn measure will be scored from this TUGT Participants will also complete the Locomotor Capabilities index LCI
At the six-month test participants repeat balance and mobility tests and LCI as well as being interviewed to ascertain fall history since discharge
Detailed Description:
Subjects
All unilateral trans-tibial amputees with prosthesis at discharge who are over 18 years of age willing to participate and give informed consent Subjects will be excluded if visually unable to perform tests cognitively unable to follow testing procedures or being discharged into supported accommodation
Identify scores for unilateral trans-tibial amputees for FSST TUGT and turn measure items 1 steps 2 time and 3 steadiness fluency of movement
Evaluate the validity predictive value sensitivity specificity of the balance and mobility measures for falls and community ambulation with trans-tibial amputees
All unilateral trans-tibial amputees with prosthesis at discharge who are over 18 years of age willing to participate and give informed consent Subjects will be excluded if visually unable to perform tests cognitively unable to follow testing procedures or being discharged into supported accommodation
Identify scores for unilateral trans-tibial amputees for FSST TUGT and turn measure items 1 steps 2 time and 3 steadiness fluency of movement
Evaluate the validity predictive value sensitivity specificity of the balance and mobility measures for falls and community ambulation with trans-tibial amputees
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None