NCT04238533

Brief Summary

The eADAPT training consists of a variety of mobile games played on a mobile app (phone or tablet). A band is worn on the residual limb. Participants use muscle activation to send signals to execute certain movements in the game.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

January 15, 2020

Last Update Submit

January 8, 2021

Conditions

Amputation

Keywords

transradialupper extremityamputeeforearm

Outcome Measures

Primary Outcomes (1)

  • Compliance

    Compliance with the respective training protocol. For conventional exercise, patients will be contacted by phone once per week and asked if they were compliant with the training protocol. For the experimental (eADAPT) training protocol, utilization time will be recorded via the app and available for download for analysis. The difference in compliance between the two protocols will be compared.

    3 weeks

Study Arms (2)

eADAPT

ACTIVE COMPARATOR

This arm includes transradial amputees who will be assessed while using the eADAPT trainer.

Other: eADAPT training

Conventional program

ACTIVE COMPARATOR

This arm includes transradial amputees who will be assessed while using the conventional training program.

Other: Conventional training

Interventions

eADAPT trainingOTHER

eADAPT training for myoelectric prosthesis users is the comparator training.

eADAPT
Conventional trainingOTHER

Conventional training with Myoboy has been the only training available to users.

Conventional program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Amputation or missing limb at or above the wrist and below the elbow (transradial)
  • Current myoelectric prosthesis user
  • Sufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
  • Sufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively;
  • The patient is free of comorbidities that could interfere with the function of the prosthesis;
  • Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual when performing activities of daily living
  • Age 18-70 years
  • Able to independently read, speak and understand English for the purpose of consent, following instructions and completing surveys

You may not qualify if:

  • Amputation or missing limb at a level that is not above the wrist and below the elbow (transradial)
  • Not currently a myoelectric user
  • Insufficient neurological and cognitive function to operate the prosthesis effectively as assessed by research personnel during initial interviews;
  • Insufficient neurological and cognitive function to operate a mobile device (phone, tablet) effectively
  • The patient has comorbidities that could interfere with function of the prosthesis;
  • Functional evaluation indicates that despite training, use of a myoelectric prosthesis is unlikely to meet the functional needs of the individual when performing activities of daily living;
  • Age \<18 or \>70 years
  • Participants with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the study procedure, or the ability to obtain relevant user feedback.
  • Unable to independently read, speak and understand English for the purpose of consent, following instructions, and completing surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James A Haley VA

Tampa, Florida, 33612, United States

RECRUITING

Study Officials

  • Jason Highsmith, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Highsmith, PhD

CONTACT

813-974-8530mhighsmi@usf.edu

Rebecca Miro, PhD

CONTACT

813-974-8530mirorm@usf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 23, 2020

Study Start

March 18, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)