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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amputation focused on measuring Transtibial amputation, visual feedback, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 16, 2017
Last Updated
October 19, 2017
Sponsor
Hacettepe University
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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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