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Clinical Trials/NCT03316248
NCT03316248CompletedNot Applicable

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

Hacettepe University1 site in 1 country24 target enrollmentStarted: January 25, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Prosthetic Weight bearing

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

visual feedback

Experimental

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

Intervention: visual feedback (Other)

Usual prosthetic rehabilitation

Active Comparator

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

Intervention: usual prosthetic rehabilitation (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elif Kırdı

Research Assistant

Hacettepe University

Study Sites (1)

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