Control of Degrees of Freedom Post-stroke for the Recovery of the Upper Limb

NCT05371444 | Completed

• 2 other identifiers: hcuch_03811181337
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Stroke

Keywords

True recovery; Neurorehabilitation; Stroke

Outcome Measures

Primary Outcomes (24)

• Normal movements Outcome. Kinematics of grasping and reaching 1

  Joint angles of the upper extremity in a water glass test

  At week 1

• Normal movements Outcome. Kinematics of grasping and reaching 2

  Joint angles of the upper extremity in a water glass test

  At week 5

• Normal movements Outcome. Kinematics of grasping and reaching 3

  Joint angles of the upper extremity in a water glass test

  At week 12

• Normal movements Outcome. Kinematics of grasping and reaching 4

  Joint angles of the upper extremity in a glass test

  At week 24

• Functioning Outcome 1

  Scale scores of Fugl Meyer Upper Limb test

  At week 1

• Functioning Outcome 2

  Scale scores of Fugl Meyer Upper Limb test

  At week 5

• Functioning Outcome 3

  Scale scores of Fugl Meyer Upper Limb test

  At week 12

• Functioning Outcome 4

  Scale scores of Fugl Meyer Upper Limb test

  At week 24

• Functioning Outcome - function of the arm1

  Scale scores of ARAT (Action Research Arm Test)

  At week 1

• Functioning Outcome - function of the arm 2

  Scale scores of ARAT (Action Research Arm Test)

  At week 5

• Functioning Outcome - function of the arm 3

  Scale scores of ARAT (Action Research Arm Test)

  At week 12

• Functioning Outcome - function of the arm 4

  Scale scores of ARAT (Action Research Arm Test)

  At week 24

• Functioning Outcome - daily life activities 1

  Scale scores of Barthel Index (independence in daily life activities)

  At week 1

• Functioning Outcome - daily life activities 2

  Scale scores of Barthel Index (independence in daily life activities)

  At week 5

• Functioning Outcome - daily life activities 3

  Scale scores of Barthel Index (independence in daily life activities)

  At week 12

• Functioning Outcome - daily life activities 4

  Scale scores of Barthel Index (independence in daily life activities)

  At week 24

• Functioning Outcome - quality of life 1

  Scale scores of EQ-5D (quality of life test)

  At week 1

• Functioning Outcome - quality of life 2

  Scale scores of EQ-5D (quality of life test)

  At week 5

• Functioning Outcome - quality of life 3

  Scale scores of EQ-5D (quality of life test)

  At week 12

• Functioning Outcome - quality of life 4

  Scale scores of EQ-5D (quality of life test)

  At week 24

• Connectivity Outcome 1

  Interhermispheric coherence of beta bands in the EEG.

  At week 1

• Connectivity Outcome 2

  Interhermispheric coherence of beta bands in the EEG.

  At week 5

• Connectivity Outcome 3

  Interhermispheric coherence of beta bands in the EEG.

  At week 12

• Connectivity Outcome 4

  Interhermispheric coherence of beta bands in the EEG.

  At week 24

Study Arms (2)

Controlled DoF

EXPERIMENTAL

The treatment that this gruop will receive consist in a training with the exoskeleton that will restrict the DoF of the arm and trunk

Behavioral: Training with restriction of the DoF

Non controlled DoF

ACTIVE COMPARATOR

The treatment that this gruop will receive consist in a training with out the exoskeleton and without restriction of the DoF

Behavioral: Training without restriction of the DoF

Interventions

Training with restriction of the DoF BEHAVIORAL

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

Controlled DoF

Training without restriction of the DoF BEHAVIORAL

The intrevention is based in the training of the upper extremity movements without the restriction of DoF

Non controlled DoF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (1) Cognitive impairment that prevents signing informed consent, following instructions and understanding procedures. (MoCA ≥ 18).
• (2) Musculoskeletal pathologies that prevent activities without pain or with limited ranges for the scope.
• (3) Severe visual impairment that does not allow the activities associated with the task.
• (4) Cerebellar o brainstem stroke.
• (5) Previous stroke leaving upper limb impairment.
• (6) Bilateral sensorimotor alterations.
• (7) Do not present alterations in functional clinical tests.

Sponsors & Collaborators

• University of Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, 8320000, Chile

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pedro Maldonado, Doctor

  University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will not now the arm to which each participant corresponds
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 12, 2022
• Study Start: April 1, 2021
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE

Locations

CL (1)