- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04325516
Decoding Motion Planning Using Cortical Potentials
Decoding Motion Planning Using Cortical Potentials in People With a Transfemoral Amputation and Able-bodied Individuals
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The evolution of lower limb prostheses has made considerable progress in the past decades. There has been a transition from passive (e.g. Total knee®, Össur) to quasi-passive (e.g. C-leg®, Otto Bock) and eventually to active prostheses (e.g. Power knee®, Össur). The development always focused on an amputation as a primary peripheral disorder. For example, manufacturers have been searching to compensate the loss of muscle mass by adding torque into the prosthesis. However, few considerations have yet been taken to the fact that central adaptations are also observed after amputation in terms of neuroplasticity and reorganization.
The atypical motion planning strategies of people with a lower limb amputation (LLA) could possibly be related to the challenges that they experience during daily activities, such as the sit to stand transfer. Standing up from a chair is a relevant clinical problem and current devices do not yet relieve the asymmetrical loading. A few studies have already investigated the muscular activity during a sit to stand movement in people with a LLA and able-bodied individuals. The movement is characterized by a forward displacement of the centre of mass with the highest activation of the m. gluteus maximus, m. adductor magnus and m. biceps femoris.The sit to stand transfer is a potential movement to investigate brain activity incorporating the advantages and disadvantages of EEG measurements.
Until now, the development of lower limb prostheses approaches people with a LLA as a peripheral disorder whereas relevant central adaptations are also observed. Therefore, the purpose of this study is to identify the cortical activity that is responsible for successfully completing a sit to stand transfer. The hypothesis is that different brain locations are activated in people with a transfemoral amputation for motion planning compared to able-bodied individuals.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Brussel, Belgia, 1050
- Rekruttering
- Vrije Universiteit Brussel
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Ta kontakt med:
- Jo Ghillebert, msc
- Telefonnummer: 0494902770
- E-post: jo.ghillebert@vub.be
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Deltakelseskriterier
Kvalifikasjonskriterier
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Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: People with a lower limb amputation
Participants will perform four tasks in a randomized order:
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Participants will perform four tasks in a randomized order:
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Eksperimentell: Able bodied individuals
Participants will perform four tasks in a randomized order:
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Participants will perform four tasks in a randomized order:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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ElectroEncephalography in milliseconds
Tidsramme: Approximatley 9 months
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Movement related cortical potential before the actual movement
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Approximatley 9 months
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ElectroMyography activity in milliseconds
Tidsramme: Approximatley 9 months
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Amplitude
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Approximatley 9 months
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ElectroMyography timing
Tidsramme: Approximatley 9 months
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Time of movement onset
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Approximatley 9 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of the sit to stand test
Tidsramme: Approximatley 9 months
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Duration of the sit to stand test
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Approximatley 9 months
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- EEGstudy
Plan for individuelle deltakerdata (IPD)
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