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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05371444 on ClinicalTrials.gov