Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb
NCT05371444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-04-26
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Training with restriction of the DoF
The intervention is based in the training of a single DoF of the upper extremity with restriction of the rest DoF of the arm and trunk that aren't being trained being restrained by an exoskeleton
- BEHAVIORAL
-
Training without restriction of the DoF
The intrevention is based in the training of the upper extremity movements without the restriction of DoF
Sponsors & Collaborators
-
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
collaborator OTHER_GOV -
University of Chile
lead OTHER
Principal Investigators
-
Pedro Maldonado, Doctor · University of Chile
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2024-04-19
- Completion
- 2024-04-19
Countries
- Chile
Study Locations
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