|- candidate number||28403|
|- NTR Number||NTR6935|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jan-2018|
|- Secondary IDs||ECB/2017.01.30_2 Ethische Commissie Bewegingswetenschappen, UMCG, Groningen (ECB)|
|- Public Title||Invloed van een amputatie van de onderarm op de aansturing van spieren in de onderarm|
|- Scientific Title||Influence of a transradial amputation on neuromuscular control of forearm muscles.|
|- hypothesis||We hypothesise that the braced condition is significantly more similar to the affected side than the non-braced condition |
|- Healt Condition(s) or Problem(s) studied||Forearm amputation, Motor control|
|- Inclusion criteria||The inclusion criteria for the participants are: individuals with acquired unilateral limb deficiency at the transradial level. The stump needs to be properly healed with sufficient reduction of stump oedema which can usually be expected 8 weeks after surgery. Participants should have a 2 cm broad region on the forearm with no scaring. Their understanding of the Dutch language needs to be sufficient to understand what they need to do in the experiment.|
|- Exclusion criteria||Anyone who do not match the inclusion criteria |
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- planned startdate ||21-feb-2017|
|- planned closingdate||1-dec-2018|
|- Target number of participants||15|
|- Interventions||The participants will be fitted with two elastic bands. Each band is fitted with 8 equally spaced clinically used electrodes (Otto Bock 13E200=50). The first band is placed on the thickest part of the forearm of the affected side that does not have scarring. The second band is placed at the same place on the unaffected side. The participant will then be placed in front of a computer monitor on which prompts will be shown that instructs the participant to perform specific bimanual movements. The participant will be instructed to perform the movements with moderate strength for three seconds. The movements are|
• Forearm supination
• Forearm pronation
• Wrist flexion
• Wrist extension
• Open hand
• Key grip
• Fine pinch
• Radial deviation
• Ulnar deviation
Each movement will be performed three times and the order of the movements will be presented in a randomised order. While performing the movements, the EMG signal measured from the electrodes on the elastic bands are saved on a computer. After the participant has performed all the movements, the same movements will be performed while wearing a wrist/hand brace on the unaffected side. The order of the brace condition is counterbalanced over participants.
After completing all the movements for both conditions (no brace and brace), the participant will fill out a short questionnaire.
|- Primary outcome||The EMG signals of forearm muscles will be measured from both limbs using the electrode bands. To compare EMG patterns during movement execution between conditions and affected / un-affected limb, we will compute three indexes:|
(1) SI (separability index): How distinct are EMG activity patterns for different movements?
(2) RI (repeatability index): How similar are patterns of the same movement if repeated?
(3) VI (variability index): How variable is each pattern over the time of one movement execution?
|- Secondary outcome||Questionnaire data|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Morten Bak Kristoffersen|
|- CONTACT for SCIENTIFIC QUERIES|| Morten Bak Kristoffersen|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|The European Council|
|- Brief summary||Questions arise as to how the control strategy of the neuromotor system changes after amputation when muscles and other tissues are rearranged, degenerated, and when the feedback loop is heavily altered due to absence of a moving limb.|
The findings of this study give a fundamental understanding of how neuromuscular plasticity, degeneration processes and altered feedback affect the production of an EMG signal to produce a movement.
|- Main changes (audit trail)|
|- RECORD||5-jan-2018 - 12-jan-2018|