Transhumeral AmputationNCT06853938
Optimizing Transhumeral Osseointegration Prosthesis Control
A study testing Myoelectric prosthesis in people with Transhumeral Amputation, run by University of Alberta at 2 sites in Canada.
Trial summary
Upper limb amputation above the elbow results in a significant loss of function. There have been many advancements in surgery and prosthetic devices to restore arm function, but many people still reject upper limb prostheses. This is due to difficulties with how the socket fits and poor control of the device. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transhumeral Amputation
- What is being tested?
- Myoelectric prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with transhumeral amputation who:
- are between 18 and 65 years old,
- have been scheduled to undergo osseointegration by the Alberta Limb Osseointegration Program.
- demonstrate adequate pain-free shoulder range of motion to perform the required tasks and have potential muscle signals for myoelectric control to be able to undertake the muscle signal training
- willing to undergo all of the study procedures and follow-up.
Who cannot join
- Individuals who:
- are unable to comply with treatment or follow-up processes,
- are unable to understand English sufficiently to provide full informed consent.
- have shoulder pathology on the side of the amputation (arthritis, adhesive capsulitis, chronic rotator cuff, or musculoskeletal dysfunction) that would negatively affect the ability to perform the training and functional assessments,
- have insufficient muscle signals to operate a myoelectric prosthesis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Jacqueline S Hebert, MD, FRCPC, 780-492-7846, jhebert@ualberta.ca
Mayank Rehani, MSc, 780-492-4736, rehani@ualberta.ca
- Recruiting
University of Alberta
Edmonton, Alberta, T6G2R3
Jacqueline S Hebert, MD, FRCPC, 780-492-7846, jhebert@ualberta.ca
Mayank Rehani, MSc, 780-492-4736, rehani@ualberta.ca
About this study
Upper limb amputation above the elbow results in a significant loss of function. There have been many advancements in surgery and prosthetic devices to restore arm function, but many people still reject upper limb prostheses. This is due to difficulties with how the socket fits and poor control of the device. Above-elbow prostheses are particularly challenging to use for several reasons. The socket must go all the way into the shoulder for stability. To hold the prosthesis onto the remaining arm, there needs to be a strap across the chest and shoulder. The prosthesis can be heavy, and the socket can slip or move around. This makes it hard to use muscle signals in the residual limb to control advanced prosthetic devices. People with limb loss are interested in advanced prostheses to use them reliably for day-to-day activities.
Bone-anchored prostheses (BAPs) are a new approach. They are for people with upper limb loss who can't use socket prostheses. The surgery involves putting a titanium rod into the remaining bone, which, over time, joins with the bone. This implant extends through the skin. It enables the direct attachment of the prosthetic parts (like the elbow and hand). With BAPs, there is no need for a socket. Also, there is a well-known surgery called "Targeted muscle reinnervation" (TMR). It improves the number of arm muscle control signals. These signals are used to control myoelectric prostheses. However, after both these surgeries, there is a lack of research that shows how best to train the muscle signals to use an advanced myoelectric arm and little evidence on what factors actually improve in a person's day-to-day life when using such a prosthesis.
This study aims to implement an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving OI and TMR for above-elbow amputation, and to evaluate the outcomes over time. The goal is to understand whether these advanced prostheses improve prosthesis use and function in daily life.
- Conditions
- Transhumeral Amputation
- Being tested
- Myoelectric prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myoelectric prosthesisDevice
The interventions in this study are (1) an enhanced muscle training protocol and (2) fitting with a myoelectric (muscle signal-controlled) prosthetic device after receiving an osseointegrated implant and targeted muscle reinnervation.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Persons with transhumeral amputation who receive an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving osseointegrated implant and targeted muscle reinnervation. Receives: Device: Myoelectric prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis-related activity
The percentage reliance on the use of the prosthesis compared to the dominant arm. Prosthesis-related activity will be measured by participants wearing activity sensor bracelets (commercially available accelerometer-based sensors, i.e. Actigraph), one on each arm, for 7 days at each assessment time point. We will calculate the sum of seconds of active use for each arm to calculate the ratio of symmetry. The primary measure will be the percentage reliance on the dominant side, calculated for when the prosthesis is worn. Measures of unilateral and bilateral activities will also be computed.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Sep 2025
- Primary completion14 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transhumeral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853938
- Sponsor's protocol ID
- Pro00140248
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Transhumeral Osseointegration Prosthesis Control
- ClinicalTrials.gov ID
- NCT06853938
- Acronym / sponsor ID
- Pro00140248
- Conditions
- Transhumeral Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 14 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Mar 2025 (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.
Upper limb amputation above the elbow results in a significant loss of function. There have been many advancements in surgery and prosthetic devices to restore arm function, but many people still reject upper limb prostheses. This is due to difficulties with how the socket fits and poor control of the device. Above-elbow prostheses are particularly challenging to use for several reasons. The socket must go all the way into the shoulder for stability. To hold the prosthesis onto the remaining arm, there needs to be a strap across the chest and shoulder. The prosthesis can be heavy, and the socket can slip or move around. This makes it hard to use muscle signals in the residual limb to control advanced prosthetic devices. People with limb loss are interested in advanced prostheses to use them reliably for day-to-day activities.
Bone-anchored prostheses (BAPs) are a new approach. They are for people with upper limb loss who can't use socket prostheses. The surgery involves putting a titanium rod into the remaining bone, which, over time, joins with the bone. This implant extends through the skin. It enables the direct attachment of the prosthetic parts (like the elbow and hand). With BAPs, there is no need for a socket. Also, there is a well-known surgery called "Targeted muscle reinnervation" (TMR). It improves the number of arm muscle control signals. These signals are used to control myoelectric prostheses. However, after both these surgeries, there is a lack of research that shows how best to train the muscle signals to use an advanced myoelectric arm and little evidence on what factors actually improve in a person's day-to-day life when using such a prosthesis.
This study aims to implement an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving OI and TMR for above-elbow amputation, and to evaluate the outcomes over time. The goal is to understand whether these advanced prostheses improve prosthesis use and function in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Myoelectric prosthesisPersons with transhumeral amputation who receive an enhanced muscle training protocol and fitting with a myoelectric (muscle signal-controlled) device after receiving osseointegrated implant and targeted muscle reinnervation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are between 18 and 65 years old,
- have been scheduled to undergo osseointegration by the Alberta Limb Osseointegration Program.
- demonstrate adequate pain-free shoulder range of motion to perform the required tasks and have potential muscle signals for myoelectric control to be able to undertake the muscle signal training
- willing to undergo all of the study procedures and follow-up.
Key exclusion criteria (5 listed)
- are unable to comply with treatment or follow-up processes,
- are unable to understand English sufficiently to provide full informed consent.
- have shoulder pathology on the side of the amputation (arthritis, adhesive capsulitis, chronic rotator cuff, or musculoskeletal dysfunction) that would negatively affect the ability to perform the training and functional assessments,
- have insufficient muscle signals to operate a myoelectric prosthesis
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 |
|---|---|---|
| Myoelectric prosthesisThe interventions in this study are (1) an enhanced muscle training protocol and (2) fitting with a myoelectric (muscle signal-controlled) prosthetic device after receiving an osseointegrated implant and targeted muscle reinnervation. | Device | Study group |
Primary outcome
Prosthesis-related activity
Time frame: From enrollment to the end of treatment at 12 months
The percentage reliance on the use of the prosthesis compared to the dominant arm. Prosthesis-related activity will be measured by participants wearing activity sensor bracelets (commercially available accelerometer-based sensors, i.e. Actigraph), one on each arm, for 7 days at each assessment time point. We will calculate the sum of seconds of active use for each arm to calculate the ratio of symmetry. The primary measure will be the percentage reliance on the dominant side, calculated for when the prosthesis is worn. Measures of unilateral and bilateral activities will also be computed.
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myoelectric prosthesis in people with Transhumeral Amputation, run by University of Alberta at 2 sites in Canada.
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 5 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 Jacqueline S Hebert, MD, FRCPC (780-492-7846, jhebert@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthesis-related activity (time frame: From enrollment to the end of treatment at 12 months). 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 18 Nov 2025.