NCT05371444Completed
Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb
Effects of Control of Joint Degrees of Freedom in the Early Rehabilitation Post-stroke for the Recovery of Normal Movement (Non-compensatory) of the Upper Limb
Source: ClinicalTrials.gov · Last updated 26 Apr 2024
Brief summary (registry, in English)
The study's methodology will be a single-blind, multicenter, parallel-group randomized controlled trial (RCT). The sample consists of stroke patients (supratentorial ischemic and hemorrhagic stroke of anterior territory) between 18 and 80 years of age, separated into 2 groups of 20 participants. The experimental group called "controlled DoF", the control group 1 called "non controlled DoF". The "controlled DoF" group will use an exoskeleton that will restrict the movement of the trunk and upper limb to release only the joint to work in the plane of interest. The "non-controlled DoF" group will receive the same therapy time as the previous group but without any restriction of joint movements. The training will be functional with multiarticular and combined planes tasks. All groups receive the conventional rehabilitation of the health center (ideally 45 minutes 1 per day). Using motion sensors, clinical scales, and electroencephalography (EEG), the data will be obtained pre-intervention, post-intervention, and in a follow-up at 3 and 6 months.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 26 Apr 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 19 Apr 2024
- Lead sponsor
- University of Chile
- Diseases
- Stroke
- NCT number
- NCT05371444
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 1 Apr 2021 to the primary completion date, 19 Apr 2024
- 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (5) Previous stroke leaving upper limb impairment.
Other illness
- (1) Cognitive impairment that prevents signing informed consent, following instructions and understanding procedures. (MoCA ≥ 18).
- (3) Severe visual impairment that does not allow the activities associated with the task.
- (4) Cerebellar o brainstem stroke.
Other
- (2) Musculoskeletal pathologies that prevent activities without pain or with limited ranges for the scope.
- (6) Bilateral sensorimotor alterations.
- (7) Do not present alterations in functional clinical tests.
Who the study is looking for
- (1) Clinical diagnosis of supratentorial ischemic stroke.
- (2) Time of onset \<72 hours.
- (3) With alterations of the active voluntary movement of UL.
- (4) At least 3/8 DoF of the UE with MRC force scale of 3 or less.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico Universidad de Chile Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.