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

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

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic Amputation
• Intervention / Treatment: Other: visual feedback; Other: usual prosthetic rehabilitation

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: visual feedback; participants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied.	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.
ACTIVE_COMPARATOR: Usual prosthetic rehabilitation; participants in the control group were applied usual prosthetic rehabilitation. 9 sessions for three days were applied.	Other: usual prosthetic rehabilitation; prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Elif Kırdı, Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2017
• Primary Completion (ACTUAL): May 12, 2017
• Study Completion (ACTUAL): June 18, 2017

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (ACTUAL): October 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation; visual feedback; Transtibial amputation
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: GO 17 / 115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No