Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05371444
Acronym
DoF_UL_S
Enrollment
45
Registered
2022-05-12
Start date
2021-04-01
Completion date
2024-04-19
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

True recovery, Neurorehabilitation, Stroke

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.

Detailed description

This proposal seeks to demonstrate if the control of joint degrees of freedom (DoF) of the trunk and upper limb is determinant during the early rehabilitation phase post-stroke (here from day 1 to day 28 or first month) for the recovery of upper limb movements without compensations and the normal brain control (true recovery). 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 receive for the initial 2 weeks, 2 hours of therapy, 5 times a week (2 sessions of 1 hour per day, 5 days) and the next 2 weeks, 2 hours of therapy, 3 times a week(2 sessions of 1 hour of therapy, 3 days), using 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 training will be selective in an articulation plane with the biofeedback of active movements (or active-assisted) employing a video game controlled by an external movement sensor installed in the segment 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. The expected results would show more functional improvements with less compensatory kinematics for therapy that control DoF than for the therapy without control of the DoF or for conventional therapy in acute post-stroke patients. About this result, the EEG connectivity analysis would show a lower interhemispheric inhibition of the motor areas and a greater frontal-parietal flow during reaching and manipulation tasks in the group with DoF control.

Interventions

BEHAVIORALTraining without restriction of the DoF

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

BEHAVIORALTraining 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

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
CollaboratorOTHER_GOV
University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

The outcomes assessors will not now the arm to which each participant corresponds

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* (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.

Exclusion criteria

* (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.

Design outcomes

Primary

MeasureTime frameDescription
Functioning Outcome - function of the arm 3At week 12Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 4At week 24Scale scores of ARAT (Action Research Arm Test)
Normal movements Outcome. Kinematics of grasping and reaching 1At week 1Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 2At week 5Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 3At week 12Joint angles of the upper extremity in a water glass test
Normal movements Outcome. Kinematics of grasping and reaching 4At week 24Joint angles of the upper extremity in a glass test
Functioning Outcome 1At week 1Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 2At week 5Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 3At week 12Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome 4At week 24Scale scores of Fugl Meyer Upper Limb test
Functioning Outcome - function of the arm1At week 1Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - function of the arm 2At week 5Scale scores of ARAT (Action Research Arm Test)
Functioning Outcome - daily life activities 1At week 1Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 2At week 5Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 3At week 12Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - daily life activities 4At week 24Scale scores of Barthel Index (independence in daily life activities)
Functioning Outcome - quality of life 1At week 1Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 2At week 5Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 3At week 12Scale scores of EQ-5D (quality of life test)
Functioning Outcome - quality of life 4At week 24Scale scores of EQ-5D (quality of life test)
Connectivity Outcome 1At week 1Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 2At week 5Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 3At week 12Interhermispheric coherence of beta bands in the EEG.
Connectivity Outcome 4At week 24Interhermispheric coherence of beta bands in the EEG.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026