Lower Limb Amputation Above Knee (Injury) Clinical Trial
Official title:
Decoding Motion Planning Using Cortical Potentials in People With a Transfemoral Amputation and Able-bodied Individuals
Verified date | May 2020 |
Source | Vrije Universiteit Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - Any neurological disease - No upper limb or bilateral amputation |
Country | Name | City | State |
---|---|---|---|
Belgium | Vrije Universiteit Brussel | Brussel |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ElectroEncephalography in milliseconds | Movement related cortical potential before the actual movement | Approximatley 9 months | |
Primary | ElectroMyography activity in milliseconds | Amplitude | Approximatley 9 months | |
Primary | ElectroMyography timing | Time of movement onset | Approximatley 9 months | |
Secondary | Duration of the sit to stand test | Duration of the sit to stand test | Approximatley 9 months |
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