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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03316248
Other study ID # GO 17 / 115
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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