Decoding Motion Planning Using Cortical Potentials
1 other identifier
interventional
10
1 country
1
Brief Summary
The team will investigate the user's intention to move by using cortical activity during a sit to stand movement performance in people with a transfemoral amputation and able-bodied individuals. The goal is to get insights in pre-movement onset indicators within the brain that initiate the sit to stand transfer. The hypothesis is that people with a transfemoral amputation use different brain locations for motion planning compared to able-bodied individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 28, 2020
May 1, 2020
4 months
March 20, 2020
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
ElectroEncephalography in milliseconds
Movement related cortical potential before the actual movement
Approximatley 9 months
ElectroMyography activity in milliseconds
Amplitude
Approximatley 9 months
ElectroMyography timing
Time of movement onset
Approximatley 9 months
Secondary Outcomes (1)
Duration of the sit to stand test
Approximatley 9 months
Study Arms (2)
People with a lower limb amputation
EXPERIMENTALParticipants will perform four tasks in a randomized order: * sit to stand * dorsi flexion of the foot * knee extension * hip extension
Able bodied individuals
EXPERIMENTALParticipants will perform four tasks in a randomized order: * sit to stand * dorsi flexion of the foot * knee extension * hip extension
Interventions
Participants will perform four tasks in a randomized order: * sit to stand * dorsi flexion of the foot * knee extension * hip extension
Eligibility Criteria
You may qualify if:
- Age: 25 - 75 years
- Gender: men and women
- Level of amputation: unilateral transfemoral
- Vascular or traumatic cause of amputation
- Medicare Functional Classification Level25: K3-4
- Participants are able to stand up from a chair and return to the seated position without support of their hands for ten repetitions
- Participants wear their prosthesis for at least 8 hours/day (Prosthetic use has been shown to have an influence on functional reorganization)
- No cognitive impairment. This will be objectified with the mini-mental state examination (score on 30)
You may not qualify if:
- Any neurological disease
- No upper limb or bilateral amputation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vrije Universiteit Brussel
Brussels, 1050, Belgium
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
March 20, 2020
First Posted
March 27, 2020
Study Start
April 1, 2020
Primary Completion
August 1, 2020
Study Completion
December 31, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share