A Novel Approach to Upper Extremity Amputation
This study is exploring a new way to perform upper arm or forearm amputations. The goal is to improve how people control advanced prosthetic limbs and to help them regain a sense of feeling and position (proprioception) in the amputated limb. Researchers will compare a modified amputation procedure, which involves carefully arranging muscle pairs, to the standard amputation procedure. They will measure how well participants can control their prosthetic, how much movement they have, and how much feeling they recover over 0-36 months. This study is for individuals aged 18-65 who are candidates for an upper extremity amputation due to injury, birth defects, or severe arthritis.
- Study design
- This interventional study plans to enroll 20 participants. Ten participants will receive the modified amputation procedure, and ten will receive the standard amputation procedure.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 36 months after their procedure to assess motor control and proprioception recovery.
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A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception
At a glance
Conditions
NCT03882073
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Brigham & Women's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Massachusetts Institute of Technology Media Lab
Cambridge, Massachusettsstudy coordinator listed
Recruiting
Walter Reed National Military Medical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Matthew J Carty, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- Motor Unit Innervation0-36 months
Intact volitional activation of motor constructs, as assessed by electromyographic evidence of activation (muscle potentials measured in mV)
- Motor Unit Excursion0-36 months
Intact volitional activation of motor constructs with measurable excursion, as assessed by ultrasound (excursion measured in mm)
- Proprioception Recovery0-36 months
Manifestation of functional proprioception with motor unit activation, as evidenced by spatial limb position testing using a modified upper limb prosthesis (accurate limb positioning relative to target measured in mm)