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

NCT ID: NCT03316248

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2017-06-18

Brief Summary

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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

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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

Conditions

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Amputation Traumatic Amputation

Keywords

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Transtibial amputation visual feedback rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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visual feedback

participants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied.

Group Type EXPERIMENTAL

visual feedback

Intervention Type OTHER

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

participants in the control group were applied usual prosthetic rehabilitation. 9 sessions for three days were applied.

Group Type ACTIVE_COMPARATOR

usual prosthetic rehabilitation

Intervention Type OTHER

prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.

Interventions

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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.

Intervention Type OTHER

usual prosthetic rehabilitation

prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Elif Kırdı

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Kırdı

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GO 17 / 115

Identifier Type: -

Identifier Source: org_study_id