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

NCT03316248 | Completed

• 1 other identifier: GO 17 / 115
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Traumatic Amputation

Keywords

Transtibial amputation; visual feedback; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

visual feedback

EXPERIMENTAL

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

Other: visual feedback

Usual prosthetic rehabilitation

ACTIVE COMPARATOR

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

Other: usual prosthetic rehabilitation

Interventions

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.

visual feedback

usual prosthetic rehabilitation OTHER

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

Usual prosthetic rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• had unilateral transtibial amputations,
• used prosthesis with total surface bearing socket (TSB) for at least 1 year
• volunteered to participate in the study

You may not qualify if:

• had any neurological disorders
• had any cognitive problems

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Amputation, Traumatic

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Study Officials

• Elif Kırdı

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: January 25, 2017
• Primary Completion: May 12, 2017
• Study Completion: June 18, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)