Upper Limb AmputationNCT07677969
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
An observational study of Upper Limb Amputation and Postural Control, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Limb Amputation, Postural Control, Neck Pain
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Adult, Older adult
Study population: This study population consists of adults aged 18-65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Participants are recruited from clinical and rehabilitation settings and meet predefined inclusion and exclusion criteria. All individuals undergo a single-session assessment to evaluate postural control, pain, daily living activities, hand function, and reaction time.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe university
Ankara
aslı bebek, MSc, +905364037230, aslisabanci97@gmail.com
About this study
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.
- Conditions
- Upper Limb Amputation, Postural Control, Neck Pain, Low Back Pain, Daily Activities, Reaction Time
- Being tested
- This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.
- Keywords
- Upper Limb Amputation, Postural Control, Neck Pain, low back pain, Daily Living Activities, reaction time
- Medical subject headings
- Neck Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.Other
This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily living activity score
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)
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Postural Sway and Limits of Stability
Postural sway (cm) measured using a force BERTEC platform system.
Measured: through study completion, an average of 1 year
Postural Sway and Limits of Stability
limits of stability (%) measured using a force BERTEC platform system.
Measured: through study completion, an average of 1 year
Neck and Back Pain Intensity
Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: through study completion, an average of 1 year
Hand Dexterity
easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
Measured: through study completion, an average of 1 year
Reaction Time
Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb AmputationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Bebek, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677969
- Sponsor's protocol ID
- FTREK25/28
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: . The study includes sensitive clinical and functional assessment data collected at a single center. All data will be securely stored and used solely for research purposes in accordance with ethical approval and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07677969
- Acronym / sponsor ID
- FTREK25/28
- Conditions
- Upper Limb Amputation, Postural Control, Neck Pain, Low Back Pain, Daily Activities, Reaction Time
- Keywords
- Upper Limb Amputation, Postural Control, Neck Pain, low back pain, Daily Living Activities, reaction time
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (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 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral Upper Limb Amputation Group | – | Other: This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study population consists of adults aged 18-65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Participants are recruited from clinical and rehabilitation settings and meet predefined inclusion and exclusion criteria. All individuals undergo a single-session assessment to evaluate postural control, pain, daily living activities, hand function, and reaction time.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements.This is an observational study. No interventional procedures are performed. All assessments are non-invasive measurements. | Other | Unilateral Upper Limb Amputation Group |
Primary outcome
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)
5 secondary outcomes
Postural Sway and Limits of Stability
Time frame: through study completion, an average of 1 year
Postural Sway and Limits of Stability
Time frame: through study completion, an average of 1 year
Neck and Back Pain Intensity
Time frame: through study completion, an average of 1 year
Hand Dexterity
Time frame: through study completion, an average of 1 year
Reaction Time
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. . The study includes sensitive clinical and functional assessment data collected at a single center. All data will be securely stored and used solely for research purposes in accordance with ethical approval and institutional regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Amputation and Postural Control, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASLI BEBEK, MSc (+905364037230, aslisabanci97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily living activity score (time frame: through study completion, an average of 1 year). 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 1 Jul 2026.