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CompletedNCT03316248Updated Oct 20, 2017

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

An interventional study of visual feedback and usual prosthetic rehabilitation in Amputation and Traumatic Amputation, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Amputation
  • Traumatic Amputation

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Keywords

  • Transtibial amputation
  • visual feedback
  • rehabilitation
03

In context

Amputation, Traumatic

112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.

This study's enrollment of 24 is above the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.

Browse Amputation, Traumatic studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • had any neurological disorders
  • had any cognitive problems
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Othervisual 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.

  • Otherusual prosthetic rehabilitation

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

06

What researchers measure

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

    Time frame: 3 minutes

07

Study locations

1 site
  • Hacettepe University
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03316248
Responsible party
Elif Kırdı (Research Assistant, Hacettepe University) — Principal investigator
First posted
Oct 20, 2017
Start date
Jan 25, 2017
Primary completion
May 12, 2017
Completion
Jun 18, 2017
Last update
Oct 20, 2017

Study contacts

Elif Kırdı
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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