Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539936
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test the following hypothesis Use of Glide results in improved functional performance satisfaction and usage metrics as compared to use of a standard Direct Control DC prosthesis
This study will compare the use of Glide Experimental prosthesis with a DC Standard prosthesis in a clinical setting and in unsupervised daily activity We will follow a multiple baseline design specifically an AB design Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks The A phase is the baseline phase where the DC prosthesis will be used and the B phase will be the treatment phase where the Glide prosthesis will be used Participants will undergo an A phase of either 10-weeks 12-weeks or 14-weeks duration with the remaining 14- 12- or 10-weeks of the study being dedicated to the B phase
This study will compare the use of Glide Experimental prosthesis with a DC Standard prosthesis in a clinical setting and in unsupervised daily activity We will follow a multiple baseline design specifically an AB design Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks The A phase is the baseline phase where the DC prosthesis will be used and the B phase will be the treatment phase where the Glide prosthesis will be used Participants will undergo an A phase of either 10-weeks 12-weeks or 14-weeks duration with the remaining 14- 12- or 10-weeks of the study being dedicated to the B phase
Detailed Description:
Recruitment and group assignment Participants will be recruited through one of Arm Dynamicss six Centers of Excellence Potentially eligible participants will be identified by their care team and referred to a study team member to go over the details of the patients involvement and the study protocol After informed consent and medical clearance are completed the study prosthetist and occupational therapist will meet with the participant and identify functional goals for their prosthesis The prosthetist will then begin fabricating the prosthesis A single prosthesis will be fabricated for use with both control strategies Switching between control methods will be done through the Glide iPad application Once fabrication is completed a clinical team member will configure the assigned control strategy with the subject to achieve maximum functional efficiency
Prosthesis delivery and occupational therapy Day 0 After the consenting process and group assignment patients will return to the clinic to be fit with the prosthesis Each prosthetic system will include IBTs Glide system remote electrodes FlexCell batteries and prosthetic componentry chosen by the patient and their clinical team The Glide system also allows for Direct Control of the prosthesis without any hardware change as long as two of the remote electrodes are positioned according to Direct Control site selection The fitting process may take multiple visits to adjust the socket The participant will be given instructions on how to use their prosthesis and activate the various functions of their initial device Occupational therapy OT will be provided over 2 days to the patient to help patients accomplish their desired activities of daily living At the conclusion of OT participants will complete baseline assessments of the CAPPFUL tBBT CAPROQ FIT DASH and SAM measures
Phase I DC prosthesis Over the course of the next 5- 6- or 7-weeks subjects will use their DC prosthesis during their everyday lives The Glide system is capable of recording usage data during these at-home periods regardless of which control system is active at a given time These measures include the Daily Mean Number of Movement Bouts DMNMB Using a web portal submission subjects will report the DMNMB and their Mean Prosthesis Wear Duration MPWD for the previous week At this time subjects will also complete the CAPROQ and FIT surveys This data submission will occur weekly
Phase I Midpoint Subjects will return to the clinic where they will first complete CAPPFUL tBBT CAPROQ FIT DASH and SAM Once completed the subject will continue Phase I
Phase I DC prosthesis Phase I procedures will be repeated DC prosthesis
Crossover checkpoint Day 70 84 or 98 Subjects will return to the clinic where they will first complete CAPPFUL tBBT CAPROQ FIT DASH and SAM Once completed they will have their control strategy transitioned to Glide They will then receive OT training and complete the same measurements using their prosthesis with Glide control
Phase II Glide prosthesis Over the course of the next 7- 6- or 5-weeks subjects will use their Glide prosthesis during their everyday lives Using the Glide system subjects will repeat the procedures outlined in Phase I
Phase II Midpoint Subjects will return to the clinic where they will first complete CAPPFUL tBBT CAPROQ FIT DASH and SAM Once completed the subject will continue Phase II
Phase II Glide prosthesis Phase II procedures will be repeated Glide prosthesis
Endpoint evaluation Day 168 Measurements from the crossover checkpoint will be made with the Glide prosthesis only The patient will be re-fit with their pre-study prosthesis and OT provided as necessary
Prosthesis delivery and occupational therapy Day 0 After the consenting process and group assignment patients will return to the clinic to be fit with the prosthesis Each prosthetic system will include IBTs Glide system remote electrodes FlexCell batteries and prosthetic componentry chosen by the patient and their clinical team The Glide system also allows for Direct Control of the prosthesis without any hardware change as long as two of the remote electrodes are positioned according to Direct Control site selection The fitting process may take multiple visits to adjust the socket The participant will be given instructions on how to use their prosthesis and activate the various functions of their initial device Occupational therapy OT will be provided over 2 days to the patient to help patients accomplish their desired activities of daily living At the conclusion of OT participants will complete baseline assessments of the CAPPFUL tBBT CAPROQ FIT DASH and SAM measures
Phase I DC prosthesis Over the course of the next 5- 6- or 7-weeks subjects will use their DC prosthesis during their everyday lives The Glide system is capable of recording usage data during these at-home periods regardless of which control system is active at a given time These measures include the Daily Mean Number of Movement Bouts DMNMB Using a web portal submission subjects will report the DMNMB and their Mean Prosthesis Wear Duration MPWD for the previous week At this time subjects will also complete the CAPROQ and FIT surveys This data submission will occur weekly
Phase I Midpoint Subjects will return to the clinic where they will first complete CAPPFUL tBBT CAPROQ FIT DASH and SAM Once completed the subject will continue Phase I
Phase I DC prosthesis Phase I procedures will be repeated DC prosthesis
Crossover checkpoint Day 70 84 or 98 Subjects will return to the clinic where they will first complete CAPPFUL tBBT CAPROQ FIT DASH and SAM Once completed they will have their control strategy transitioned to Glide They will then receive OT training and complete the same measurements using their prosthesis with Glide control
Phase II Glide prosthesis Over the course of the next 7- 6- or 5-weeks subjects will use their Glide prosthesis during their everyday lives Using the Glide system subjects will repeat the procedures outlined in Phase I
Phase II Midpoint Subjects will return to the clinic where they will first complete CAPPFUL tBBT CAPROQ FIT DASH and SAM Once completed the subject will continue Phase II
Phase II Glide prosthesis Phase II procedures will be repeated Glide prosthesis
Endpoint evaluation Day 168 Measurements from the crossover checkpoint will be made with the Glide prosthesis only The patient will be re-fit with their pre-study prosthesis and OT provided as necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None