- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677969
The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation
This observational study aims to examine the relationship between the percentage of limb loss and functional outcomes in individuals with unilateral upper limb amputation. Upper limb amputation can affect posture, balance control, pain levels, daily living activities, hand function, and reaction time. However, limited research has investigated how the amount of limb loss influences these outcomes.
Participants between 18 and 65 years of age who use a myoelectric or bionic prosthesis will undergo a series of assessments. These assessments include measurements of postural control using a force platform, posture analysis, evaluation of neck and low back pain using a visual analog scale, daily living activities using a validated questionnaire, hand dexterity using the Box and Block Test, and reaction time using a visual stimulus device.
The study does not involve any intervention or treatment. All evaluations will be performed during a single assessment session. The results of this study may help improve rehabilitation planning and provide better understanding of functional changes associated with different levels of limb loss in people with upper limb amputation.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ASLI BEBEK, MSc
- Phone Number: +905364037230
- Email: aslisabanci97@gmail.com
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Recruiting
- Hacettepe University
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Contact:
- aslı bebek, MSc
- Phone Number: +905364037230
- Email: aslisabanci97@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18-65 years
- Unilateral upper limb amputation
- Use of a myoelectric or bionic prosthesis for at least 1 year
- Current prosthesis use for a minimum of 3 months
Exclusion Criteria:
- Bilateral upper limb amputation
- Additional amputation of another limb
- Use of passive or cosmetic prosthesis
- Presence of neurological or other significant orthopedic disorders unrelated to amputation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Unilateral Upper Limb Amputation Group
Participants in this cohort are adults aged 18 to 65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Individuals must have been using their current prosthesis for at least three months and have a minimum of one year of prosthesis experience. Participants with additional neurological or orthopedic conditions, bilateral amputation, or passive/cosmetic prosthesis use are excluded. This is an observational study. No interventional procedures are performed. All participants undergo a single assessment session including measurements of postural control, posture, neck and low back pain, daily living activities, hand dexterity, and reaction time. |
This is an observational study.
No interventional procedures are performed.
All assessments are non-invasive measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily living activity score
Time Frame: through study completion, an average of 1 year
|
In upper extremity amputees, daily living activities and occupational skills will be assessed using a questionnaire.
(0-100 score, Survey on Activities of Daily Living and Occupations of Upper Extremity Amputees)
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Sway and Limits of Stability
Time Frame: through study completion, an average of 1 year
|
Postural sway (cm) measured using a force BERTEC platform system.
|
through study completion, an average of 1 year
|
|
Postural Sway and Limits of Stability
Time Frame: through study completion, an average of 1 year
|
limits of stability (%) measured using a force BERTEC platform system.
|
through study completion, an average of 1 year
|
|
Neck and Back Pain Intensity
Time Frame: through study completion, an average of 1 year
|
Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
|
through study completion, an average of 1 year
|
|
Hand Dexterity
Time Frame: through study completion, an average of 1 year
|
easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
|
through study completion, an average of 1 year
|
|
Reaction Time
Time Frame: through study completion, an average of 1 year
|
Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FTREK25/28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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