AmputationNCT05261178
Evaluation of Satisfaction and Effect on Daily Living Activities With the Use of Myoelectric Controlled Prosthesis
An observational study of Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
Trial summary
Myoelectrically controlled arm prostheses are often offered to individuals with upper extremity limb loss in order to restore body balance and compensate for the lack of grasping ability during the rehabilitation process. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- Evaluation of satisfaction and the level of daily living activities using the prosthesis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2022
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months
Who may be able to join
- Being between the ages of 18-65
- Having an upper extremity amputation
- Using myoelectric controlled arm prosthesis for at least 3 months
Who cannot join
- Being under the age of 18
- Having significant cognitive or hearing impairment that would preclude participation in research
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Satisfaction With the Use of Myoelectric Controlled Prosthesis and Its Effect on Daily Living Activities in Patients With Upper Extremity Amputation
Myoelectrically controlled arm prostheses are often offered to individuals with upper extremity limb loss in order to restore body balance and compensate for the lack of grasping ability during the rehabilitation process. Myoelectrically controlled prostheses utilize the presence of two independent signals from a set of agonist and antagonist muscles. However, individuals with upper extremity amputation may not want to use their prosthesis. One of the reasons for not wanting to use the prosthesis is prosthesis dissatisfaction. This study aims to evaluate prosthesis satisfaction and the effect of prosthesis use on daily living activities of upper extremity amputees using myoelectric controlled prosthesis.
Read the detailed description
The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. Patients' satisfaction with using their prosthesis will be evaluated with TAPES (Trinity Amputation and Prosthesis Experience Scale) and daily living activities using their prosthesis with SF-36 (Short Form-36).
- Conditions
- Amputation
- Being tested
- Evaluation of satisfaction and the level of daily living activities using the prosthesis
- Keywords
- myoelectric controlled protheses, satisfaction, daily living activities
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of satisfaction and the level of daily living activities using the prosthesisOther
Evaluation of satisfaction with using the prosthesis with TAPES (Trinity Amputation and Prosthesis Experience Scale) and the level of daily living activities using the prosthesis with SF-36 (Short Form-36)
| Study group | Role | What they receive |
|---|---|---|
| Upper extremity amputation patients using myoelectric controlled prosthesis | 20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months Receives: Other: Evaluation of satisfaction and the level of daily living activities using the prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trinity Amputation and Prosthesis Experience Scale
It consists of two parts after the first part, which includes demographic and disability-related information. Part I covers psychosocial adjustment, activity restriction, and satisfaction with the prosthesis. In the second part, there are questions about how many hours a day the prosthesis is worn on average, general health status and physical capacity. The scores are summed up with a subscale score between 10 and 50. Higher scores correspond to satisfaction with the prothesis.
Measured: Through study completion, an average of one and a half months
SF-36 (Short Form-36)
It consists of eight scales (general health, physical function, physical role, emotional role, social function, pain, energy, mental health), each varying between 2-10 questions, and a health course question that is not included in the scoring. Each question is scored on only one scale. Scoring is made between 0-100 for each scale. The lowest score represents the worst health condition.
Measured: Through study completion, an average of one and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Oct 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Fatma Özcan, MD, Principal investigator, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261178
- Sponsor's protocol ID
- 27
- Status last verified
- Feb 2022
- First submitted
- 19 Feb 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Satisfaction With the Use of Myoelectric Controlled Prosthesis and Its Effect on Daily Living Activities in Patients With Upper Extremity Amputation
- ClinicalTrials.gov ID
- NCT05261178
- Acronym / sponsor ID
- 27
- Conditions
- Amputation
- Keywords
- myoelectric controlled protheses, satisfaction, daily living activities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 2 Mar 2022 (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.
Myoelectrically controlled arm prostheses are often offered to individuals with upper extremity limb loss in order to restore body balance and compensate for the lack of grasping ability during the rehabilitation process. Myoelectrically controlled prostheses utilize the presence of two independent signals from a set of agonist and antagonist muscles. However, individuals with upper extremity amputation may not want to use their prosthesis. One of the reasons for not wanting to use the prosthesis is prosthesis dissatisfaction. This study aims to evaluate prosthesis satisfaction and the effect of prosthesis use on daily living activities of upper extremity amputees using myoelectric controlled prosthesis.
Detailed description
The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. Patients' satisfaction with using their prosthesis will be evaluated with TAPES (Trinity Amputation and Prosthesis Experience Scale) and daily living activities using their prosthesis with SF-36 (Short Form-36).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper extremity amputation patients using myoelectric controlled prosthesis | – | Other: Evaluation of satisfaction and the level of daily living activities using the prosthesis20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients aged 18-65 years with upper extremity amputation and using myoelectric controlled arm prosthesis for at least 3 months
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Having an upper extremity amputation
- Using myoelectric controlled arm prosthesis for at least 3 months
Key exclusion criteria (2 listed)
- Being under the age of 18
- Having significant cognitive or hearing impairment that would preclude participation in research
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 |
|---|---|---|
| Evaluation of satisfaction and the level of daily living activities using the prosthesisEvaluation of satisfaction with using the prosthesis with TAPES (Trinity Amputation and Prosthesis Experience Scale) and the level of daily living activities using the prosthesis with SF-36 (Short Form-36) | Other | Upper extremity amputation patients using myoelectric controlled prosthesis |
Primary outcome
Trinity Amputation and Prosthesis Experience Scale
Time frame: Through study completion, an average of one and a half months
It consists of two parts after the first part, which includes demographic and disability-related information. Part I covers psychosocial adjustment, activity restriction, and satisfaction with the prosthesis. In the second part, there are questions about how many hours a day the prosthesis is worn on average, general health status and physical capacity. The scores are summed up with a subscale score between 10 and 50. Higher scores correspond to satisfaction with the prothesis.
SF-36 (Short Form-36)
Time frame: Through study completion, an average of one and a half months
It consists of eight scales (general health, physical function, physical role, emotional role, social function, pain, energy, mental health), each varying between 2-10 questions, and a health course question that is not included in the scoring. Each question is scored on only one scale. Scoring is made between 0-100 for each scale. The lowest score represents the worst health condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
Fatma Özcan, MD principal investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Özcan, MD (05078689545, fatma_yumus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trinity Amputation and Prosthesis Experience Scale (time frame: Through study completion, an average of one and a half months). The study lists 2 primary outcomes in all. 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 30 Sep 2022.