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NCT06538506Not yet recruitingPhase 2

ANIMATOR - RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control

ANIMATOR - A Single-blind Randomized Controlled Trial of RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control

Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

ANIMATOR aims to examine how BCI therapy vs. attention based control therapy can be used to treat people in the chronic phase of stroke with moderate to severe upper extremity impairment. This interventional trial has two phases: Pilot (10 consecutive days of intervention) and a Randomized Phase (24 sessions over 8 weeks).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
1 Aug 2024
Start date
Aug 2024
Primary completion date
Mar 2027
Lead sponsor
University of Calgary
Diseases
Stroke
NCT number
NCT06538506

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From Aug 2024 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • enrollment in concurrent interventional trial

Other illness

  • have neurologic history in addition to stroke (injury or disease), eg. TBI, MS, dementia
  • major co-morbid illness making study completion unlikely

Other

  • Potential participants will be excluded if they do not meet the requirements above, or:
  • contraindication to MRI (such as pacemaker, pregnancy, etc).

Who the study is looking for

  • Stroke survivors, ≥ 6 months post-stroke with severe arm impairment.
  • 18 years of age of older
  • Adequate language skills to be able to follow instructions
  • FM-UE score 30 or less at study entry (i.e., severe arm impairment and would likely not use the stroke-affected arm in daily activities)
  • Modified Ashworth Score ≦ 2
  • Visual acuity 20/50 corrected (both eyes)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Foothills Hospital
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.