Prosthesis UserNCT04030585
Robot-assisted Exercise in Patients With Amputation Using Myoelectric Prosthesis
A study testing Robot and Home exercise in people with Prosthesis User and Amputation, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Amputation
- What is being tested?
- Robot and Home exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2019to 13 Nov 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Upper elbow amputation
- Being using myoelectric prosthesis for amputated upper extremity
- Be literate
- To be able to complete and complete the tests at the level of mental and physical activity
- Being 18-65 years old
Who cannot join
- Patients with neurological sequelae
- Patients who could not cooperate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34192
About this study
Official title: Efficacy of Robot-assisted Exercise Program in Patients With Upper Limb Amputation Using Myoelectric Prosthesis
The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In the literature review, There is no robot-assisted exercise program applied in patients using upper extremity myoelectric prosthesis.
The expected benefit from this study is to show that the functional status, depressive status, and quality of life of the patients who received robot-assisted biofeedback exercise were better than those who had a home exercise program only.
Read the detailed description
The study was planned as a randomized prospective clinical study. The study was planned to include 16 patients. New amputation patients will be excluded from the study. The patients in the study group will have 5 sessions of exercise in the hospital for a week. The control group will receive a home exercise program.
Statistical analysis Student t-test will be used for the comparison of descriptive statistical methods (mean, standard deviation, median, frequency, and ratio) and normal distribution parameters between groups. Pearson chi-square test, Yates Continuity Correction, Fisher-Freeman-Halton Exact Test, Fisher Exact Test, and Marginal Homogeneity Test will be used to compare qualitative data. The results will be evaluated at 95 % confidence interval and p <0.01 and p <0.05.
- Conditions
- Prosthesis User, Amputation
- Being tested
- Robot, Home exercise
- Keywords
- Amputation, robotic rehabilitation, Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotDevice
Patients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program
Home exerciseOther
Patients with upper limb amputation using myoelectric prosthesis will done home exercise program
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted exercise | Experimental | Robot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis Receives: Device: Robot |
| Home exercise | Active comparator | Home exercise program will applied by patients with upper limb amputation using myoelectric prosthesis Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic data
range of motion (ROM): unit is degree
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start24 Jul 2019
- Primary completion13 Nov 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prosthesis UserStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group: robot-assisted exercise program Control: Home exercise program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- TUGBA AYDIN, MD, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030585
- Sponsor's protocol ID
- MYO-2019
- Status last verified
- Dec 2021
- First submitted
- 22 Jul 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Biffi E, Maghini C, Cairo B, Beretta E, Peri E, Altomonte D, Mazzoli D, Giacobbi M, Prati P, Merlo A, Strazzer S. Movement Velocity and Fluidity Improve after Armeo(R)Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: An Observational Study. Biomed Res Int. 2018 Nov 18;2018:1537170. doi: 10.1155/2018/1537170. eCollection 2018.
PubMed 30581845Aydin T, Kesiktas FN, Akbulut YD, Corum M, Ones K, Kizilkurt T, Bugdayci ND, Karacan I. The efficacy of robot-assisted training for patients with upper limb amputations who use myoelectric prostheses: a randomized controlled pilot study. Int J Rehabil Res. 2022 Mar 1;45(1):39-46. doi: 10.1097/MRR.0000000000000506.
PubMed 34775437
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Robot-assisted Exercise Program in Patients With Upper Limb Amputation Using Myoelectric Prosthesis
- ClinicalTrials.gov ID
- NCT04030585
- Acronym / sponsor ID
- MYO-2019
- Conditions
- Prosthesis User, Amputation
- Keywords
- Amputation, robotic rehabilitation, Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 13 Nov 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 24 Jul 2019 (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.
The aim of this study was to investigate the effect of a robot-assisted biofeedback exercise program on grip strength, movement speed, coordination, functional status, depressive status, and quality of life in patients with a myoelectric prosthesis with upper limb amputation. In the literature review, There is no robot-assisted exercise program applied in patients using upper extremity myoelectric prosthesis.
The expected benefit from this study is to show that the functional status, depressive status, and quality of life of the patients who received robot-assisted biofeedback exercise were better than those who had a home exercise program only.
Detailed description
The study was planned as a randomized prospective clinical study. The study was planned to include 16 patients. New amputation patients will be excluded from the study. The patients in the study group will have 5 sessions of exercise in the hospital for a week. The control group will receive a home exercise program.
Statistical analysis Student t-test will be used for the comparison of descriptive statistical methods (mean, standard deviation, median, frequency, and ratio) and normal distribution parameters between groups. Pearson chi-square test, Yates Continuity Correction, Fisher-Freeman-Halton Exact Test, Fisher Exact Test, and Marginal Homogeneity Test will be used to compare qualitative data. The results will be evaluated at 95 % confidence interval and p <0.01 and p <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment group: robot-assisted exercise program Control: Home exercise program
| Arm | Type | Receives |
|---|---|---|
| robot-assisted exercise | Experimental | Device: RobotRobot-assisted exercise program will applied by patients with upper limb amputation using myoelectric prosthesis |
| Home exercise | Active comparator | Other: Home exerciseHome exercise program will applied by patients with upper limb amputation using myoelectric prosthesis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Upper elbow amputation
- Being using myoelectric prosthesis for amputated upper extremity
- Be literate
- To be able to complete and complete the tests at the level of mental and physical activity
- Being 18-65 years old
Key exclusion criteria (2 listed)
- Patients with neurological sequelae
- Patients who could not cooperate
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 |
|---|---|---|
| RobotPatients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program | Device | robot-assisted exercise |
| Home exercisePatients with upper limb amputation using myoelectric prosthesis will done home exercise program | Other | Home exercise |
Primary outcome
Kinematic data
Time frame: 1 day
range of motion (ROM): unit is degree
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 17 Dec 2021.
- Background: PubMed 30581845Biffi E, Maghini C, Cairo B, Beretta E, Peri E, Altomonte D, Mazzoli D, Giacobbi M, Prati P, Merlo A, Strazzer S. Movement Velocity and Fluidity Improve after Armeo(R)Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: An Observational Study. Biomed Res Int. 2018 Nov 18;2018:1537170. doi: 10.1155/2018/1537170. eCollection 2018.
- Derived from this study: PubMed 34775437Aydin T, Kesiktas FN, Akbulut YD, Corum M, Ones K, Kizilkurt T, Bugdayci ND, Karacan I. The efficacy of robot-assisted training for patients with upper limb amputations who use myoelectric prostheses: a randomized controlled pilot study. Int J Rehabil Res. 2022 Mar 1;45(1):39-46. doi: 10.1097/MRR.0000000000000506.
Related trials for Prosthesis User
Active, not recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
Recruiting
Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
Prosthesis User, Prosthesis
Active, not recruiting
Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration
Amputation, Prosthesis User
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.
TUGBA AYDIN, MD study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot and Home exercise in people with Prosthesis User and Amputation, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 5 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 17 Dec 2021. 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?
Kinematic data (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04030585, which also lists 2 linked publications.
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 17 Dec 2021.