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Completed

NCT Number: NCT05371444

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile

Santiago, 8320000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Training without restriction of the DoF

Behavioral

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

Primary outcomes

  1. Normal movements Outcome. Kinematics of grasping and reaching 1

    Time frame: At week 1

    Joint angles of the upper extremity in a water glass test

  2. Normal movements Outcome. Kinematics of grasping and reaching 2

    Time frame: At week 5

    Joint angles of the upper extremity in a water glass test

  3. Normal movements Outcome. Kinematics of grasping and reaching 3

    Time frame: At week 12

    Joint angles of the upper extremity in a water glass test

  4. Normal movements Outcome. Kinematics of grasping and reaching 4

    Time frame: At week 24

    Joint angles of the upper extremity in a glass test

  5. Functioning Outcome 1

    Time frame: At week 1

    Scale scores of Fugl Meyer Upper Limb test

  6. Functioning Outcome 2

    Time frame: At week 5

    Scale scores of Fugl Meyer Upper Limb test

  7. Functioning Outcome 3

    Time frame: At week 12

    Scale scores of Fugl Meyer Upper Limb test

  8. Functioning Outcome 4

    Time frame: At week 24

    Scale scores of Fugl Meyer Upper Limb test

  9. Functioning Outcome - function of the arm1

    Time frame: At week 1

    Scale scores of ARAT (Action Research Arm Test)

  10. Functioning Outcome - function of the arm 2

    Time frame: At week 5

    Scale scores of ARAT (Action Research Arm Test)

  11. Functioning Outcome - function of the arm 3

    Time frame: At week 12

    Scale scores of ARAT (Action Research Arm Test)

  12. Functioning Outcome - function of the arm 4

    Time frame: At week 24

    Scale scores of ARAT (Action Research Arm Test)

  13. Functioning Outcome - daily life activities 1

    Time frame: At week 1

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

  14. Functioning Outcome - daily life activities 2

    Time frame: At week 5

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

  15. Functioning Outcome - daily life activities 3

    Time frame: At week 12

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

  16. Functioning Outcome - daily life activities 4

    Time frame: At week 24

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

  17. Functioning Outcome - quality of life 1

    Time frame: At week 1

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

  18. Functioning Outcome - quality of life 2

    Time frame: At week 5

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

  19. Functioning Outcome - quality of life 3

    Time frame: At week 12

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

  20. Functioning Outcome - quality of life 4

    Time frame: At week 24

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

  21. Connectivity Outcome 1

    Time frame: At week 1

    Interhermispheric coherence of beta bands in the EEG.

  22. Connectivity Outcome 2

    Time frame: At week 5

    Interhermispheric coherence of beta bands in the EEG.

  23. Connectivity Outcome 3

    Time frame: At week 12

    Interhermispheric coherence of beta bands in the EEG.

  24. Connectivity Outcome 4

    Time frame: At week 24

    Interhermispheric coherence of beta bands in the EEG.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Registry information

Official study title

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

Acronym: DoF_UL_S

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 12, 2022
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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