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Completed

NCT Number: NCT03316248

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

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.

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Key information

Conditions

Amputation Amputation, Traumatic Traumatic Amputation Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual feedback

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

Other

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

Primary outcomes

  1. Prosthetic Weight bearing

    Time frame: 3 minutes

    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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 20, 2017
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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