Decoding Motion Planning Using Cortical Potentials

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04325516
• Other study ID #: EEGstudy
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lower Limb Amputation Above Knee (Injury)

Intervention

Behavioral:
• Daily activities
Participants will perform four tasks in a randomized order: sit to stand dorsi flexion of the foot knee extension hip extension

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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