AmputationNCT03316248
The Effect of Visual Feedback on Function, Stability and Quality of Life in Transtibial Amputation
A study testing visual feedback and usual prosthetic rehabilitation in people with Amputation and Traumatic Amputation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Traumatic Amputation
- What is being tested?
- visual feedback and usual prosthetic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2017to 18 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had unilateral transtibial amputations,
- used prosthesis with total surface bearing socket (TSB) for at least 1 year
- volunteered to participate in the study
Who cannot join
- had any neurological disorders
- had any cognitive problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Amputation, Traumatic Amputation
- Being tested
- visual feedback, usual prosthetic rehabilitation
- Keywords
- Transtibial amputation, visual feedback, rehabilitation
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual feedbackOther
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 rehabilitationOther
prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.
| Study group | Role | What they receive |
|---|---|---|
| visual feedback | Experimental | participants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied. Receives: 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. Receives: Other: usual prosthetic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start25 Jan 2017
- Primary completion12 May 2017
- Study completion18 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kırdı, Hacettepe University
- Investigators
- Elif Kırdı, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316248
- Sponsor's protocol ID
- GO 17 / 115
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Visual Feedback on Function, Stability and Quality of Life in Individuals With Transtibial Amputation
- ClinicalTrials.gov ID
- NCT03316248
- Acronym / sponsor ID
- GO 17 / 115
- Conditions
- Amputation, Traumatic Amputation
- Keywords
- Transtibial amputation, visual feedback, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- 18 Jun 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visual feedback | Experimental | Other: visual feedbackparticipants in the experimental group were applied usual prosthetic rehabilitation with visual feedback methods. 9 sessions for three days were applied. |
| Usual prosthetic rehabilitation | Active comparator | Other: usual prosthetic rehabilitationparticipants in the control group were applied usual prosthetic rehabilitation. 9 sessions for three days were applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- had unilateral transtibial amputations,
- used prosthesis with total surface bearing socket (TSB) for at least 1 year
- volunteered to participate in the study
Key exclusion criteria (2 listed)
- had any neurological disorders
- had any cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual feedbackin 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. | Other | visual feedback |
| usual prosthetic rehabilitationprosthetic weight bearing and balance exercises were applied to the control group for 9 sessions. | Other | Usual prosthetic rehabilitation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Amputation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Kırdı principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual feedback and usual prosthetic rehabilitation in people with Amputation and Traumatic Amputation, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Weight bearing (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.