The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation
Primary Purpose
Amputation, Traumatic Amputation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
visual feedback
usual prosthetic rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Amputation focused on measuring Transtibial amputation, visual feedback, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- had unilateral transtibial amputations,
- used prosthesis with total surface bearing socket (TSB) for at least 1 year
- volunteered to participate in the study
Exclusion Criteria:
- had any neurological disorders
- had any cognitive problems
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
visual feedback
Usual prosthetic rehabilitation
Arm Description
participants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied.
participants in the control group were applied usual prosthetic rehabilitation. 9 sessions for three days were applied.
Outcomes
Primary Outcome Measures
Prosthetic Weight bearing
minimal (Min WB) and maximal (Max WB) values were visually recorded on the amputated side for three consecutive minutes.
The average weight bearing on the amputated side (Ml) was calculated by dividing the sum of maximal and minimal weight bearing values by two.
The percentage of total body weight (TBW) borne through the amputated limb was then determined using the formula:
(Ml/TBW) x 100
Secondary Outcome Measures
Full Information
NCT ID
NCT03316248
First Posted
October 16, 2017
Last Updated
October 19, 2017
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT03316248
Brief Title
The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation
Official Title
Investigation of the Effect of Visual Feedback on Function, Stability and Quality of Life in Individuals With Transtibial Amputation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
June 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was conducted to examine the effect of visual feedback on function, stability and quality of life in transtibial amputees. A total of 24 subjects who had unilateral transtibial amputations, used prosthesis with total surface bearing socket (TSB) for at least 1 year and volunteered to participate in the study were included. Before and after Treatment subjects were evaluated with "LASAR Posture" for prosthetic weight bearing (PWB), "Berg Balance Scale (BBS)" and "Timed Up& Go Test (TUG)" for balance and functional mobility, "2-Minute-Walk-Test (2MWT)" for physical performance, "Satisfaction with the Prosthesis Questionnaire (SATPRO)" for prosthetic pleasure and "Nottingham Health Profile (NHP)" for health- related quality of life. Participants were randomly divided into two equal groups as study and control groups. After the evaluations the same exercises; PWB exercises, balance exercises, anteroposterior and lateral weight shifting, obstacle course, walking on different grounds were applied to the the study group with visual feedback methods and control group.
Detailed Description
Inclusion criteria:
had transtibial amputation
>18 years old
had total surface bearing socket at least one year
Outcome measures:
Prosthetic weight bearing
Berg Balance Scale
Timed up &go Test
2 Minute Walk Test
Satisfaction of prosthesis questionnare
Nottingham health profile
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Traumatic Amputation
Keywords
Transtibial amputation, visual feedback, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
visual feedback
Arm Type
Experimental
Arm Description
participants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied.
Arm Title
Usual prosthetic rehabilitation
Arm Type
Active Comparator
Arm Description
participants in the control group were applied usual prosthetic rehabilitation. 9 sessions for three days were applied.
Intervention Type
Other
Intervention Name(s)
visual feedback
Intervention Description
in the study group, subjects were applied for example prosthetic weight bearing exercises in front of the mirror. They watched their reflected image while doing exercises.
Intervention Type
Other
Intervention Name(s)
usual prosthetic rehabilitation
Intervention Description
prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.
Primary Outcome Measure Information:
Title
Prosthetic Weight bearing
Description
minimal (Min WB) and maximal (Max WB) values were visually recorded on the amputated side for three consecutive minutes.
The average weight bearing on the amputated side (Ml) was calculated by dividing the sum of maximal and minimal weight bearing values by two.
The percentage of total body weight (TBW) borne through the amputated limb was then determined using the formula:
(Ml/TBW) x 100
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
had unilateral transtibial amputations,
used prosthesis with total surface bearing socket (TSB) for at least 1 year
volunteered to participate in the study
Exclusion Criteria:
had any neurological disorders
had any cognitive problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Kırdı
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation
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