The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation

Amputation Clinical Trial

Official title:

Investigation of the Effect of Visual Feedback on Function, Stability and Quality of Life in Individuals With Transtibial Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316248
• Other study ID #: GO 17 / 115
• Status: Completed
• Phase: N/A
• First received: October 16, 2017
• Last updated: October 19, 2017
• Start date: January 25, 2017
• Est. completion date: June 18, 2017

Study information

• Verified date: October 2017
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Inclusion criteria:

1. had transtibial amputation

2. >18 years old

3. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 18, 2017
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Amputation, Traumatic
• Traumatic Amputation

Intervention

Other:
• visual feedback
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.
• usual prosthetic rehabilitation
prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 minutes